Microbiologist- permanent position (Westwood)
Compensation: $111,680.00 - $166,760.00 /year *
Employment Type: Full-Time
Industry: Scientific Research
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MICROBIOLOGIST I, ENVIRONMENTAL MONITORING SPECIALIST, RCM
This position will be based in Somerset NJ 08873 until March 2020 then will transition to the Totowa NJ 07511 site
The Microbiologist/Environmental Monitoring Specialist supports manufacturing activities at the NJ5 site by (1) detecting, quantifying, identifying and investigation possible contaminants that may impact the quality of product during different stages of the manufacturing process, (2) establishing and monitoring the state of microbiological control at the site, and (3) assessing aseptic behavior and practices of site personnel and assessing the effectiveness of cleaning and sanitization programs at the site.
Essential Duties and Responsibilities
Assist in the oversight of the site environmental monitoring (EM) program including developing and maintaining sampling schedules in accordance with procedures, performing sampling of rooms, equipment and personnel, and performing EM sample management from incubation through isolate ID and completion of EM documentation.
Perform investigations, determine root cause and collaboratively determine required corrective actions for EM excursions, also evaluating EM results for trends that may indicate declining microbiological control of the GMP production environment.
Support finished product release by performing sterility, endotoxin and particulate matter testing (as required).
Support aseptic process simulation activities by participating in media fills as needed and by performing (or coordinating) all subsequent incubation, growth promotion, and isolate ID if needed.
Coordinate all subcontracted B/F, growth promotion and isolate ID activities, including sample control and tracking, defining testing requirements, and assuring subcontracted laboratories are aware of target completion dates.
Overseeing the inventory of EM materials and other materials required for media fills and finished product testing, including working with the Production Manager/Scheduler to ensure adequate inventories are ordered and maintained and that order frequency is timely and sufficient to allow for completion of subcontracted testing before the materials are needed.
Perform sterility failure and media fill failure investigations, if needed. Perform other sterility assurance and microbiology related investigations.
Write, review, approve, and implement procedures, specifications, processes, and methods as required.
Liaise with internal and external inspectors and representatives, as the site Microbiology expert.
Work cooperatively with the corporate Director Sterility Assurance to develop, evaluate and maintain site Sterility Assurance initiatives. Also, as needed, participate in network Microbiology/Sterility Assurance initiatives and investigations.
Develop and deliver training related to microbiology and sterility assurance to site personnel.
Ensure all microbiology testing equipment, incubators and facilities are maintained in a compliant manner at all times.
Review job relevant trends (e.g. environmental monitoring, cleaning, sanitization, etc.) to initiate corrective and preventive actions and/or for continuous process improvement.
Conduct review of aseptic operations to ensure compliance to internal procedures (e.g. gowning, cleaning, sanitation, sterility, environmental monitoring, etc.).
Ensure compliance to all applicable standard operating procedures.
Maintain gowning validation and other qualifications as necessary (including participating in media fills) to enter ISO 7 production areas and ISO 5 enclosures for the purpose of performing EM and evaluating aseptic practices.
Identify opportunities to bring subcontracted microbiological testing in-house.
Bachelors Degree in a Life Science discipline (B.Sc. in microbiology or biology preferred) and 4 years in a cGMP laboratory/ production environment including performing environmental monitoring, or masters degree in a Life Science discipline (microbiology or biology preferred) and 2 years in a cGMP laboratory/ production environment including performing environmental monitoring.
Knowledge of USP, FDA, and cGMP regulations preferred.
Knowledge of how and ability to write, review, and revise SOPs required.
Ability to read, analyze, and interpret governmental regulations, professional journals, or technical procedures required.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.
Ability to effectively present information, deliver training, and respond to questions from groups of managers, clients, customers, and the general public required.
Ability to define problems, collect data, establish facts and draw valid conclusions required.
Ability to solve problems and handle issues required.
Proficiency in MS Office applications required.
Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required.
Why Kelly ? With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year. You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today. About Kelly At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
Associated topics: aseptic, bacteria, bio, biology, biostatistics, life science, microbiology, physical, protein, virus
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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