PERSONAL SUMMARY. Ensures company food products and business initiatives meet Food Safety and Regulatory requirements, Collaborates cross functionally and globally to create alignment of microbiological programs across the company, Recommends and oversees content updates to department or company resource manuals, standards manuals, training programs, and operational excellence tools. Prepare and sterilize laboratory equipment to ensure its availability for use, dispose of biohazard materials appropriately, and perform monthly preventive maintenance. Reports include trip, audit, and current status, Ability to effectively communicate with cross functional groups located both externally and internally within the organization, Knowledge of problem solving technical problems in a structured method, Perform statistical analysis on data sets and be able to interpret results, Conducts quality audits on appropriate regulatory and procedural requirements, Ability to motivate closure of open Corrective Action Preventative Action (CAPA) incidents, Ability to write, review, updates and approves Quality SOP’s, Perform and report microbiological tests to support manufacturing (both in-house and contract), validations, environmental monitoring, etc, Ensure completion of all laboratory investigations including documentation, Ensure laboratory equipment preventive maintenance is completed on schedule. In addition, he/ she will be supervising a team of lab analyst/ technicians, Provide support to the site Sterility Assurance Group, This role is responsible for assisting the sterility assurance specialist in setting the standards and systems for bio-burden and its control, Ensuring that the bio-burden data is accurate and representative and that the process is adequately assessed and documented, Ensuring that the Biological Indicator validation is accurate and fully compliant with the sterilization monograph and site procedures including proper storage, assessment, use and measurement of the BI’s used in the validation process, Assessment/ approval of changes with regard to sterility assurance/ bioburden control systems in conjunction with the sterility assurance specialist, Provide leadership and direction in all areas relating to the sterility assurance of the product, Ensure clear communication to all stakeholders and customers, Ensure systems are in place to such that all site microbiological activities are carried out in compliance with product license commitments, cGMP and Quality standards, To lead all microbiological discussions during regulatory inspections and internal audits, Anticipate and plan for future requirements within remit, including such aspects as procedural requirements, compliance requirements, efficiency developments and anticipated changes needed to reflect future demand for services from the departments, Ensure safe practices are adhered to at all times in the laboratory, Identify and support training needs required for the site and the QC team, Ensure clear and measurable goals are set in a timely manner for both QC and BU teams, To take the responsibility to engage employees to enable the delivery of the departments functional goals including financial and people development, Provide support to, and deputize for, the QC Manager as required, Provide support to the QC Management team as required, Foster an environment of continuous improvement and providing leadership in this area by identifying and implementing practices to deliver efficiency, cost reduction, quality and service level improvements across the site, Responsible for the QC Technical Support & Release Team, Support the development of the deputy site microbiologist role and work with these personnel to develop and implement continuous improvement projects from a microbiological perspective, Provide support and technical expertise to the site to ensure people and technical skills are in place to implement new technologies and apply best practice in Microbiological techniques and systems, To ensure that all company policies are adhered to by self, Primary degree in Science essential supported by a sound technical background in Microbiology or equivalent knowledge and experience, Proven years microbiology expertise in a regulated Pharmaceutical industry essential, Excellent interpersonal and communication skills with good leadership abilities, Experience of direct interaction with Regulatory Bodies (e.g. HelpBU and bottlers on micro test protocol design. ), Test raw ingredients, finished products and environmental samples, Testing of finished products using pour plate, petrifilm and rapid micro test methods for sterility, Monitor plant and laboratory environment by taking swabs, air and water samples at set frequency, Participate in the AOAC proficiency testing. Demonstrates potential for technical proficiency and scientific creativity, Under the supervision of other scientists, carry out activities in support of the manufacturing of pharmaceutical products. Microbiologist CV template. Troubleshoot excursions and guide, Guide the manufacturing site in the analysis and interpretation of test results. The employee must occasionally lift and/or move up to 25 pounds. or higher degree in science or Pharmaceutical Science (pharmaceutical experience preferred). of Veteran's Affairs indicating you receive a non-service connected pension; AND a copy of your veteran's disability letter from the Dept. **, Proficiency in Microsoft applications, such as Word and Excel, and have the ability to learn new systems quickly, A fundamental understanding of the concepts and theories around microbiology and the ability to translate microbial technical concepts to all levels of the organization as well as external customers, Excellent communication, teamwork and influencing skills and the ability to articulate the science through the entire product life cycle, Must be able to read, write, and speak English, Must be able to willing and able to work in such environments wearing safety equipment, such as respirators, earplugs, goggles, and steel-toed shoes, Must be able to willing and able to work in such environments with frequent bending, reaching, and lifting, Must be willing and able to stand or walk for extended periods of time, 3 to 5 years in a cosmetic/beauty care GMP manufacturing environment and Food or Pharmaceutical GMP experience would be preferred, Experience with rapid micro identification principles such as MALDI-TOF or phenotypic characterization and laboratory information systems such as LIMS is desired, Understanding of US and European Cosmetic, Food, and Industrial Product regulatory requirements and guidelines is preferred, Payment of relocation expenses is not authorized, Payment of recruitment incentives is authorized, Selected applicants may qualify for credit toward annual leave accrual based on prior non-federal work experience or uniformed service experience, This position is not in the bargaining unit, Your application materials must clearly demonstrate this experience. Ability to take an issue from concept to full completion of the task, Demonstrated ability to decipher the meaning of, and where, 5+ years of applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience, Must understand the fundamentals of two of the following sterilization techniques: gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, or dry heat, Demonstrated experience with biocompatibility tests, ability to interpret the associated industry guidelines, Prefer demonstrated competency in advanced testing technologies, Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures, Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives, Ability to effectively work cross-functionally with Product Development, Operations and Marketing, Demonstrated communication skills across different, Must be results oriented, a quick learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met, Demonstrated ability to technically mentor associate engineers and scientists. Buddy System), Ensuring that all Quality Systems within the department are adhered to on a daily basis, Ensuring correct labelling of laboratory reagents and samples, Troubleshooting any erroneous analytical data obtained (Involvement in Lab Investigations Reports), Helping to ensure laboratory SOPs and specifications are kept up to date and in a state of compliance, Training other laboratory staff as requested and appropriate, At least 3 years' experience working within a pharmaceutical cGLP environment (IMB and FDA approved), At least 2 years' experience working in a Microbiological testing role, Environmental monitoring of cleanrooms for viable air, viable surface and particulate in line with ISO 14644 standards, Monitoring of utilities including all grades of water, and where necessary, compressed air, Co-ordination of samples for bioburden and endotoxin testing, Trending and interpreting all associated data. If you consider a position that is not within the area you reside you will be responsible for all cost that incur. Tap/click on the one you wish to review or edit. The incumbent must be able to make routine decisions concerning the suitability of test material, data, and equipment to ensure accuracy and compliance, The incumbent must possess a broad knowledge of microbiological procedures and methods and must be familiar with Current Good Documentation Practices, International Standards Organization regulations, and the Compendia methods of the United States Pharmacopia, European Pharmacopia, as well as appropriate guidelines for performance as they relate to method development, method validation, and routine testing, This position supports the overall manufacturing processes of the facility and may be required to work some evenings or weekends to ensure certain validation, production or other facility and laboratory requirements are met in a manner that supports the requirements of customers and the business, Bayer Core Competencies: Drives Results, Collaborates, Plans & Aligns, Manages Complexity, and Customer Focus, National Diploma in Biotechnology or equivalent, Minimum of 1-2 years’ experience in a micro laboratory or similar environment, Candidate must be numerically literate, mustbe fluent in English (written and verbal ), Good communication and good interpersonal skills, Experience in a manufacturing environment, Microbiological testing lab experience in the pharmaceutical industry, Ability to work off shift, holidays and facility shut downs, Perform / evaluate sterilization studies, validations and revalidations in support of sterile devices and validated processes. Generate scientific data to support Microbiology claims, Expertly interpret the experimental data and generate scientific reports communicate with the internal project teams. and microbiology methods, Experience with general documentation practices and cGMP compliance with notebooks, data entry forms with specific attention to details, Experience with common microbiology lab instrumentation (i.e. to evaluate existing parenteral products manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination, Identification and definition of acceptable aseptic manipulations, and interventions and the associated controls, to be used in manufacturing processes based on risk analysis, Execution of a risk-based approach to identify areas of highest risk in support of sampling location selection for Environmental Monitoring Performance Qualification and eventual identification of routine environmental monitoring sampling sites, Lead or provide consultation for investigation of sterility assurance-related events and non-conformances, Develop/maintain site programs for training and qualification of aseptic personnel, Represent/defend site sterility assurance strategies during internal assessments/audits and external regulatory inspections, Influences corporate guidance associated with sterility assurance, Develop sterility assurance strategies to be employed for new facilities/utilities or processes, Provide oversight of the site TS/MS integrated sterility assurance programs including: aseptic process simulations, cleaning / sanitization programs, aseptic manipulation / intervention programs, sterility assurance risk assessment strategies, discard strategies, filter validation, and sanitization agent validation, Develop and implement targeted process improvements, as well as strategic-level transformations, to site sterility assurance programs, Serve as a sterility assurance subject matter expert and liaison for IPM across the global parenteral network helping to drive change, harmonization and replication, Bachelors in Microbiology with a minimum of 10 years experience, or a Masters in Microbiology (or related scientific field) with 7 years minimum experience, Knowledge and understanding of cGMPs and global compliance expectations for aseptic processing (e.g. It’s actually very simple. Exp with low moisture foods highly desirable, Solid hands-on laboratory microbiology skills (bacteria, including major foodborne). The complete application package must be submitted by 11:59 PM (EST) on Wednesday, April 26, 2017to receive consideration, Veterans Preference Documentation, if applicable, Schedule A Eligibility Letter if you are applying as a Schedule A candidate, Knowledge and application of laboratory procedures and techniques. bioburden testing, environmental monitoring, sterility testing, GPQ testing etc, Develop and author protocols and new procedures and to revise existing procedures to comply with requirements, Timely completion of documentation and data entry for routine test procedures, Assist in laboratory investigations such as out of specification (OOS) results for routine samples as well as sterility failures. Oversees key stakeholder review of relevant operations communication vehicles, Develops and delivers effective communications that provide partners at all levels with appropriate awareness and knowledge of microbiological standards, program updates and process changes, Stays up to date and builds expertise in food microbiology best practices, public health regulations and industry best practices, Auditing and leading continuous improvement of vendor quality assurance systems (10 years), Executing total quality management program for a food manufacturer (10 years), Ability to analyze complex data, draw conclusions and make recommendations, Ability to articulate and sell quality assurance programs and continuous improvement goals to vendors, Ability to assimilate new information quickly and react positively to new and challenging opportunities, Ability to communicate effectively with supplier management team, internal customers and peers, Ability to conduct scientific tests of food products, Ability to make progress in spite of setbacks or lack of clarity, Ability to operate effectively in a fast-changing environment, Ability to solve vendor quality problems through data, processes and influencing skills, Familiarity with quality documentation system, Knowledge of food processing technology, ingredient functionality, microbiology and food safety, Knowledge of quality assurance program methodologies and implementation within manufacturing environment, Performs preservative efficacy testing on new developmental formulations, existing products requiring modification, and experimental projects, Media preparation, culture maintenance, culture and media waste disposal, Track and communicate data and results to Supervisor, Maintain adequate levels of lab supplies, chemicals and medium, Exceptional time management skills with the ability to organize and manage multiple priorities, Set up, adjust, calibrate, clean, maintain, troubleshoot and document laboratory equipment including autoclave, Documentation of testing results, equipment measurements, and media prep, Ensure that Good Laboratory Practices are employed and followed, Assist in writing, revising and editing standard operating procedures for microbiological testing, Assist in the training of more junior team members, Exhibit competence with computer systems available to R&D for formula management, requesting tests etc. third party laboratories), Good knowledge of Regulatory, GMP’s and ISO Quality management system standards, Define the strategy for preservation of the products developed by the Consumer Health organization. | Conduct analysis for microbial limits, assay, microbial identification, environmental monitoring, etc, Calibrates equipment as required, in accordance with set methods and procedures, Reports malfunctioning equipment to Laboratory Supervisors or deputies for repair, Alerts Laboratory Supervisors or deputies verbally in the event of any result not meeting Impax specification or of any questionable results generated, Ensures adequate stocking of Laboratory reagents and consumables, through monitoring re-order levels and timely notification to Laboratory Supervisors or deputies, Records expiry dates of analytical reagents developed in-house by noting the expiry date on container or document, Handles and disposes dangerous materials, such as pathogen, arsenic, cyanide, and concentrated acids, in accordance with standard safety practices, Records regulated toxic controlled chemicals usage and disposition in accordance with standard predetermined procedures, Maintains neatness of laboratory that following the concept of 6S – Sort, Set in order, Shine, Standardize, Sustain, Safety, Supports investigative testing and investigation activities, Perform in a continuous improvement attitude to meet the predetermined KPI, Follows the training program schedule to complete the directed training courses, Performs certification activities in accordance with regulatory and industry requirements like granted license for operating autoclave, Completes delegated tasks by the agreed completion date and treat as commitment, Attends weekly laboratory meetings or delegated meetings, Other duties as assigned by the supervisors or company, B.S. MS Word, MS Excel, e-mail), Must understand basic lab safety, bio-hazard and chemical waste disposal practices, Ability & Flexibility to work a rotational schedule to support a 24/7 plant facility operation, Team Building/Relationship Building - Develops relationships with people throughout the facility and demonstrate team work, Diploma /Bachelor of Science (Microbiology /Chemistry) or related field or equivalent, Fresh Degree /Diploma with Min 3 years or, Degree with Min 3 years /Diploma with Min 6 years, Technical knowledge on lab equipments/ system/ software/ validations, Annual Leave for non-federal service authorized: May Be Authorized, Time in grade (TIG) must be met within 30 days of the closing date of the announcement, Ability to gain the trust of others by taking responsibility for own actions and telling the truth, Knowledge of principles and techniques related to the analysis, presentation and exchange of data, Ability to commit to satisfying internal and external customers, Travel, transportation, and moving expenses will be paid: No, Current or Former Political Appointees: Agencies must seek prior approval from the Office of Personnel Management (OPM) before they can appoint a current or recent political appointee to a competitive or non-political excepted service position at any level under the provisions of title 5, United States Code. degree in Microbiology or a biological science degree with Microbiology coursework, Pharmaceutical microbiology experience is required, Must have well-developed communication and interpersonal skills and the ability to work independently and with others in a team situation, The incumbent must be able to follow directions, both verbal and written, This position will be considered off-shift with hours of 12:00pm to 8:00pm Monday through Friday, Bachelor’s and/or advanced degree in microbiology or closely related field of study, Work experience with medical or laboratory data base(s). ISO, Research, Security, Weapons, Assessments, Coding, Compliance, Data Analysis, Documentation, HVAC, Tags for this Online Resume: Review and sign off completed paperwork prior to being sent to the Documentation Centre, Perform daily solution bio burden testing, examining total count, coliform count and spore count in accordance with SOP. Create a job alert for [job role title] at [location]. Report clear and defensible assay results, Review and approve all microbiological test results for environmental monitoring, raw materials, growth promotion, utilities and In process samples, Good working knowledge of Microsoft Excel, Word, Strong verbal and written communication skills, Minimum of 1 year of combined work experience in Quality, Technical, Manufacturing, and/or Laboratory environment, Bachelor’s degree or higher in Microbiology, Biology, Chemistry, Chemical Engineering, or BioMedical Engineering, or related discipline from an accredited institution, Experience with and complete understanding of ISO 11135, ISO 11137, ISO 10993-7 and 11737 international sterilization and microbiological standards for medical devices, Experience with Ethylene Oxide (EO) and Gamma Irradiation sterilization technologies, Experience working with quality systems applied to health care industry: ISO 13485 and FDA QSR for medical devices, cGMP for drug products, Minimum BS degree in a relevant scientific discipline, Minimum 2 years’ experience in a pharmaceutical or comparable environment, Familiarity with Drug cGMP, GLP and GMP regulations, Demonstrate ability to communicate effectively in a team environment, Proficient with laboratory computer software, Demonstrate flexibility in carrying out a variety of assignments in a high-quality work environment, Ability to complete assigned task with minimum supervision, Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to others' ideas and tries new things, Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings, Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information, Teamwork - Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests; able to build morale and group commitments to goals and objectives; supports everyone's efforts to succeed, Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values; benefits organization through outside activities; supports affirmative action and respects diversity, Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality, The work environment is representative of a group laboratory environment, While performing the duties of this job, the employee is frequently required to use hands to finger, handle, or feel. A minimum of a bachelor's degree in food science or … Develop and share expert functional knowledge, educating individuals across both NPD and the wider AWC team. Prepare documentation for internal use and regulatory submission including, SOPs, technical reports and dossier modules, Be accountable for all meeting all assigned Quality Engineering deliverables, Ensure the quality of products produced at Playtex Business Unit is consistent with EPC / Playtex Mfg. The item will expand and provide your current status, along with additional information about that application. Test Raw-Materials and Finished Goods aseptically for aberrant growth. Step through the process as you did the first time, taking care to make the changes you need, and submitting in the final step, Knowledge of a wide variety of concepts, principles, practices and methods applicable to microbiology and/or related biological sciences such as biochemistry or physiology, Ability to analyze/interpret scientific data, Knowledge of advanced principles, concepts, practices, standards and regulations relating to microbiology and/or related biological sciences such as biochemistry or physiology, To all testing in the lab through instruction via manuals and through training, Problem solving is required when test results are out-of-specification to assign a cause and rule lab error, Impact of actions: Depending on error, there would be an explanation on a deviation report or voluntary/FDA for a major error, Install lab equipment, performs qualification and validation activities of lab equipment following written protocols, Conduct and validate necessary test methods or compendia methods in the lab and performs routine testing and documentation, Recommend solutions to optimize test procedures to improve overall efficiency, Facilitate health authorities’ inspections and internal audits within area of work, Be the on-site technical expert for microbiology laboratory testing including bioburden testing, pyrogen testing, and other required routine/non-routine testing for medical device manufacturing, Lead, mentor, and train microbiology laboratory technicians on laboratory testing requirements for routine/non-routine testing, Perform critical records documentation and review and participate in documentation preparation and assistance for regulatory audit review. and the micro. dose audit), Internal technical document creation and approval, Resource for sterilization and cleaning issues for new product development, Biocompatibility assessment and organization of respective testing, Endotoxin assessment, organization and trending, Reusable device cleaning and sterilization review and validation, Review and preparation of procedures and documents to keep pace with AAMI/ISO standard development, Support the (senior) project microbiologists for special projects, Bachelor’s degree in relevant scientific disciplines, such as microbiology, cell biology and molecular biology, Ability to solve a variety of complex sterilization, microbiological and contamination control issues, Good knowledge of industry standards (AAMI, ISO, ASTM etc). Specific duties for the position to include microbiological testing, providing input for projects, training of other employees, knowledge of laboratory and manufacturing systems, troubleshooting, document maintenance, environmental monitoring, media production and growth promotion, water testing, raw material testing, microbial identification and other duties as required, Provide daily microbiological testing support under little supervision, Collaborate with senior and associate members of group on method development and validation projects, Provide training of other employees on technical, cGMP, safety and administrative aspects of job, Support creation, revision and maintenance of documents including SOPs, methods, protocols and reports, Carry out sampling/testing of purified and potable water systems using aseptic techniques, Perform environmental monitoring of manufacturing and support areas using SAS volumetric and contact plate test applications, Drive production of microbiological media including materials autoclaving, broth/agar medium production, nutritional adequacy/growth promotion culturing, pH assessment and inventory management, Execute TOC, conductivity and microbiology assessments of water systems, employing on-line and manual methodologies, Standard Methods membrane filtration and colony enumeration, Perform Microbial Limits Testing of raw materials and products per USP methodology including total aerobic/yeasts and molds quantitative methodology and qualitative organism presence/absence tests and perform preparatory testing/suitability of the test method, Carry out identification of microbial isolates via traditional staining and culturing techniques and Vitek ID systems, Drive input for continuous improvement activities (LEAN, SS) through participation intra-and interdepartmentally, Minimum of 2 years experience of routinely processing a variety micro samples including release testing, and environmental monitoring with minimal supervision in a cGMP Pharmaceutical setting, Prefer experience with root cause analysis as it relates to microbiological issues, Experience with Rapid Micro testing techniques, equipment and method validation is a plus, Ensure quality and compliance in accordance with established procedures and standards of the Quality System, Comply with and support the GSK Environmental, Health and Safety policies and procedures, Accurately perform microbiological testing for raw materials, finished products, stability samples, environmental monitoring samples, validation samples and all other micro related samples according to prescribed methods in order to comply with required government, corporate, and site regulations, Write, review, and update Microbiology SOPs, methods, and Quality Control Specifications in accordance with cGMP and USP guidance, Perform microbial characterization and identification of microbial results, Work in partnership with other Microbiologists in Consumer Healthcare and act as a member of the Microbiological Functional Group, Analyze and trend environmental and water data and alert management of any trends potentially affecting product quality, Make and test, microbial growth media and reagents. 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Validation protocols and reports to support microbiology claims, Expertly interpret the experimental and. Supporting current and future business needs for [ job role title ] at [ location ] eligibility all. Resume to help you get an interview respond to all laboratory activities including stock control download the pharmaceutical resume... Are looking to move out of academia responsibility requires: monthly audits with department supervisors ; written audit reports the! Bachelors is required, 1 to 5 years of relevant experience, proven science and experience... Mathura ( U.P. of sterility related non-conformances percent error, variance, standard deviation, correlation regression... And production may fax all of your materials viruses, algae, fungi and! Include: 1. medicine 2. healthcare 3. research 4. agriculture and food or pharmaceutical science ( experience. 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