Group Leader QC Chemistry

Job DetailsLevel ManagementJob Location ADMA Biologics - Boca Raton, FLPosition Type Full TimeEducation Level 4 Year DegreeJob Category QA - Quality ControlDescription

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 underserved 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 Leader QC Chemistry!

The Group Leader QC Chemistry will Oversees the routine lab activities including evaluation of workloads and job assignments, scheduling work to meet deadlines, training employees, and troubleshooting when required, Leads multiple quality control initiatives and provides direction to junior staff.  Viewed as an proficient and skilled chemist in Chemical/Biochemical Quality Control.  Provides direction to and reviews work of less experienced quality control resources.  Uses knowledge and creativity to resolve complex problems. 

 

Qualifications

• Oversee the routine lab activities within cGMP guidelines.

• Maintain a clean and safe working environment.

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

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

• Perform quality control testing for raw materials, and production/stability/development 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.

• Troubleshoot test methods for quality control testing of raw materials and production/stability/development samples.  Write and execute validation protocols or other special projects for analytical testing when required by Quality Control management.

• 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 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’ timecards as related to PTO, jury duty, etc.

Education Requirements:     B.S. or M.S. in Chemistry, Biochemisty, Biological Sciences, Medical Technologist or related science discipline or equivalent work experience in pharmaceutical or biopharmaceutical fields.

Experience Requirements:    At least eight years of experience in Chemical/Biochemical testing, including experience in a regulated environment (FDA, EPA, etc).  Knowledge of FDA cGMP requirements is an essential pre-requisite for this position.  Supervisory experience is beneficial, but not a requirement. Supervisory experience very helpful.

 

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

 

Fast growing company. Redesigning HR of the future for ADMA. Benefit eligible on day 30. 100% paid eye care, life insurance, STD and LTD.  75% employer paid medical with low premiums. PTO of 12 per year for first two years and then goes up from there, holidays, three floating holidays. 4% match 401k vested from day 1. Pet insurance with very low premium. 
Just awarded 2023 Best Places to Work.

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.