Supervisor QC Bioanalytics

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 Supervisor QC Bioanalytics!

The Supervisor QC Bioanalytics  will supervise and be responsible for the daily operation of QC Bioanalytics lab. Ensuring all laboratory testing is performed in accordance to cGMP, regulatory guidelines and company’s standard operating procedures. Leads multiple quality control initiatives.  Be able to use knowledge and creativity to resolve complex problems. 

Qualifications

• Provide leadership and mentorship to the chemists in QC Bioanalytics team. Set goals to develop team expertise and monitor team performance.

• Accountable for testing per Standard Operating Procedures (SOPs), proper training of employees and ensuring compliance to cGMP guidelines.

• Maintain a clean and safe working environment.

• Provide appropriate guidedance to troubleshoot and solve problems.

• Supervise QC testing for products, stability samples and raw materials if applicable. Prioritize work based on production schedule, assign tasks to analysts and meet deadlines.

• Must have knowledge and/or expertise in product test assays performed by the QC Bioanalytics team. Troubleshoot test methods when necessary. 

• Perform review and/or approve data generated by the analysts in a timely manner and in accordance with SOPs.

• Track, trend and analyze data as needed. Prepare written reports, and data summaries when required by Quality Control management.

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

• Write and oversee the execution of validation protocols and other special projects for supporting the assays and instruments used by QC Bioanalytics team.

• Perform and participate in laboratory investigations and devistions. 

• Act as SME during investigations, audits and regulatory inspections.

• Identify opportunities for process improvements and guide the team through completion of responsible tasks.

• Approve employees’ timecards including PTO, jury duty, etc.

Education Requirements:     B.S. or M.S. in Chemistry, Biochemisty, Biological Sciences, Molecular Biology 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) or a combination of prior experience and education.  Knowledge of FDA regulations for cGMP requirements is an essential pre-requisite for this position.  Supervisory experience is required.

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 dental, 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.