Group Lead QC Microbiology (23290)

Adma Biologics Inc Boca Raton , FL 33427

Posted 4 weeks ago

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this under served population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Group Lead Microbiology!

The Group Lead Microbiology Oversees the routine lab activities including evaluation of workloads, job assignments, scheduling work to meet deadlines, training employees, and troubleshooting when required. Leads multiple quality control initiatives, selects testing methods, and provides direction to junior staff. Viewed as a proficient, skilled, subject matter expert in Chemical/Microbiological/Biochemical Quality Control. Viewed as a proficient, skilled, subject matter expert in Chemical/Microbiological/Biochemical method development/validation. Viewed as an subject matter expert in quality system compliance. Provides direction to and reviews work of less experienced quality control resources. Uses knowledge, and creativity to resolve complex problems.

Qualifications

Responsibilities:

  • Oversee the routine lab activities within cGMP guidelines.

  • Maintain a clean, and safe working environment.

  • Evaluate workload, and assign tasks to microbiologists on a daily basis.

  • Prioritize work based on routine, production schedule, and meet deadlines.

  • Perform quality control testing for raw materials, product, and environmental monitoring samples, according to approved Standard Operating Procedures and cGMP guidelines. Complete testing documentation, and data entry as required for procedures and tests performed.

  • Review, and/or approve data generated by other analysts in the laboratory.

  • Accountable for following Standard Operating Procedures (SOPs), and adhering to cGMP guidelines.

  • Select, develop and troubleshoot test methods for quality control testing of raw materials, product, and environmental monitoring samples. Write, and oversee the execution of, validation protocols, or other special projects for analytical testing to support manufacturing activities.

  • Write, and revise Standard Operating Procedures according to cGMP guidelines.

  • Prepare written reports, and data summaries, as required by Quality Control management.

  • Use creativity, cGMP guidelines, SOPs, and thorough knowledge of chemistry/biochemistry/microbiology to obtain solutions to complex problems as directed by QC management.

  • Maintain current knowledge in field of expertise.

  • Perform instrument calibration or qualification according to written procedures.

  • Approve employees' time cards as related to PTO, jury duty, etc.

Education Requirements:

B.S. or M.S. in biochemistry, biological sciences, microbiology, biotechnology molecular and cellular biology,or related science discipline. Equivalent education from work experience in pharmaceutical, or bio pharmaceutical fields.

Experience Requirements:

At least eight years of experience in a Chemical/Biochemical/Microbiological laboratory, including experience in a federally regulated environment (FDA, EPA, etc). Knowledge of FDA regulations for cGMP requirements is an essential pre-requisite for this position. Supervisory experience is beneficial, but not a requirement.

In addition to competitive compensation, we offer a comprehensive benefits package including:

  • 401K plan with employer match and immediate vesting

  • Medical, Vision, Life and Dental Insurance

  • Pet Insurance

  • Company paid STD and LTD

  • Company Paid Holidays

  • 3 Weeks' Paid Time Off (within the first year)

  • Tuition Assistance (after the first year)

  • Easily accessible to Tri-Rail

  • Free shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer.

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Group Lead QC Microbiology (23290)

Adma Biologics Inc