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 Manager, Quality Control - Microbiology in Boca Raton, FL.
The Manager, Quality Control - Microbiology will lead and develop the Quality Control microbiological team while providing testing function oversight in support of environmental monitoring/utilities, raw materials, and in-process and finished products for ADMA Biologics production at the Boca Raton site.
Qualifications
- Ability to lead the Quality Control microbiology and environmental monitoring team with emphasis on mentoring, guidance, training, and development of staff in a 24/7, fast paced, FDA regulated work environment.
- Provide feedback (formal and informal, positive and constructive) to team members on routine basis.
- Ability to work cross functionally and coordinate work with other teams onsite including manufacturing and facilities.
- Able to prioritize and communicate testing, timelines, and performance expectations to junior supervisory and technical staff.
- Strong working knowledge of WFI systems, clean room control and operation, environmental monitoring technologies and trending, aseptic manufacturing concepts, and microbiological testing (sterility, endotoxin, bioburden etc.).
- Responsible for all aspects of microbial assay (method) development, assay validation, and assay transfer. This includes, but is not limited to, the establishment of justifiable acceptance criteria, drafting, review, and approval of protocols and final reports.
- Accountable for maintaining area of operation in compliance with cGMP requirements, cUSP requirements (as appropriate), environmental health and safety policies, and all governmental regulatory requirements for the biopharmaceutical and plasma derived blood products industry.
- Drive 5S, lean laboratory, and other continuous improvement projects to increase efficiency.
- Manages collected testing, department, and facility key performance indicators and the assessment of the data on a periodic basis for trending purposes.
- Provide directional oversight to investigations (deviations, Out-of-Specification, alert and action limit) and ensure effective CAPA implementation for the microbiology laboratory.
- Direct department related change control activities and be able to provide expertise and assessment on those originated in other areas.
- Ensure equipment needs are evaluated and identified including associated documentation for Validation, Qualification, and Implementation.
- Responsible for team headcount and hiring and ensuring team is appropriately staffed.
- Lead and manage the drafting, maintenance, and review of regulatory submissions, SOPs, methods, raw materials specifications, validation protocols and reports.
- Serve as the primary presenter and interface for FDA audits or other inspections in area in microbiology.
Education Requirements:
Bachelor's Degree Microbiology or a related scientific discipline is required. Advanced degree is preferred.
Experience Requirements:
At least 5 years of working experience in a quality control laboratory at a pharmaceutical or biopharmaceutical GMP facility with at least 2 years of leadership/supervisory experience. Thorough knowledge of cGMP, ICH guidelines, current USP policy and methodology, FDA guidelines and inspection requirements, and industry guidance in the areas of pharmaceutical microbiology.
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 and Personal Days
- 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
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ADMA Biologics is an Equal Opportunity Employer.