QC Microbiologist Lead

Nature and Scope

This position will oversee overall routine testing of support staff, implementation of improvements in laboratory operations, procedures, and documents, maintenance of change controls, and performance of higher-level laboratory testing in the Quality Control Microbiology Laboratory, as needed. Position is expected to ensure compliance to guidance regulations and good manufacturing practices.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

The duties and responsibilities of Lead, Microbiology are following but not limited to:

• Successfully operate all instruments including; pH meter, Balances, Autoclave, Vitek ID Systems, BET System, Sterility Isolators/Laminar Flow Hoods/Biological Safety Cabinets, Active Air Samplers, Depyrogenation oven, etc.

• Assist in monitoring lab activities and coordination of personnel and testing to ensure a smooth and timely operation.

• Maintain an adequate supply of inventory levels and order supplies based on workload requirements.

• Write and review technical protocols and reports for APRs, method development/validations, trend reports, special projects, equipment qualification, method transfer, etc.

• Undertake or oversee special projects, validation of new equipment/software, and introduction of new tests or procedures in the laboratory.

• Review testing results and documentation as required.

• Offer input/suggestions for improvement in laboratory operations and procedures.

• Initiate change controls to methods and procedures requiring modifications.

• Assist in the operation, calibration, preventative maintenance, and troubleshooting of lab instruments.

• Maintain well-organized documentation regarding all activities listed above.

• Train and provide technical assistance and guidance to microbiologists as necessary.

• Perform investigations into out of specification or limits occurrences. Provide CAPAs where needed.

• Ensure microbiologists' compliance to current procedures, GMPs, and GDPs.

• Assume supervisory duties in the absence of supervisor. Perform any other tasks/duties as assigned.

• We all must embrace the QUALITY culture.

Qualifications and Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• BS Degree in Microbiology or related science with a minimum of Six (6) years of pharmaceutical laboratory experience (required) or MS Degree in Microbiology or related science with four (4) years relevant laboratory experience (preferred).

• Strong background in microbiological techniques and testing, method development.

• Ability to work independently.

• Knowledge of Vitek, BET, MODA/LIMS, PMS, MS Word, Excel and Outlook.

• Experience reviewing others' testing results and documentation, preferred.

• Strong oral and written communication skills.

• Detail oriented, advanced microbiology knowledge, strong project/time management skills.

• Ability to work overtime as needed.

Expected Salary range:

$100,400 - $115,000

The salary range displayed is the minimum and maximum salary range for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.