QA Manager - Contract - Kennett Square, PA
Proclinical is seeking a Quality Assurance Manager to oversee quality assurance, quality control, and compliance within a compounding pharmacy operation. This role focuses on ensuring adherence to USP standards (795, 797, 800), state pharmacy board regulations, and FDA expectations.
Primary Responsibilities:
The successful candidate will play a key role in maintaining and improving quality systems, training programs, and documentation standards to ensure the safe and compliant preparation of compounded medications.
Skills & Requirements:
- Bachelor's degree in pharmacy, Chemistry, Microbiology, or a related science (advanced degree preferred).
- Expertise in USP 795, 797, 800, and relevant state/federal regulations for 503A operations.
- Experience leading audits and managing regulatory inspections.
- Proficiency in quality systems (QMS), document control software, and data integrity principles (21 CFR Part 11 awareness preferred).
- Strong analytical and problem-solving skills, with experience implementing CAPAs and continuous improvement programs.
- Excellent communication and leadership abilities.
- Familiarity with environmental monitoring, media fill validations, and sterility assurance best practices.
- Prior experience in both 503A and 503B environments is a plus but not required.
The QA Manager's responsibilities will be:
Regulatory Compliance & Quality Systems:
- Ensure compliance with USP 795, 797, 800, state board regulations, and FDA guidance.
- Develop, implement, and maintain the Quality Management System (QMS), including SOPs, change control, deviations, CAPAs, and risk assessments.
- Prepare for and lead audits and inspections by state boards, FDA, and third parties.
- Monitor regulatory changes and update policies, procedures, and training accordingly.
Quality Assurance & Control:
- Oversee the release and approval of compounded products in line with internal quality standards.
- Lead batch record reviews, product testing, and resolution of quality-related issues or deviations.
- Ensure proper execution and review of environmental monitoring, cleanroom qualifications, and sterility assurance programs.
- Conduct routine observations of QA/QC activities, including aseptic techniques and environmental monitoring.
- Generate and review reports on quality trends, deviations, and key performance indicators (KPIs), escalating critical findings as needed.
- Lead investigations into non-conformances and implement effective CAPAs.
Leadership & Cross-Functional Collaboration:
- Manage and develop QA/QC personnel, fostering a culture of quality and accountability.
- Collaborate with pharmacy operations and compounding staff to address risks and maintain compliance with USP standards.
- Facilitate communication between production and QA/QC teams to uphold GMP discipline.
Training & Documentation:
- Develop and maintain USP-compliant training programs tailored to staff roles.
- Ensure training records, SOPs, logs, and controlled documents are accurate and audit ready.
- Support employee onboarding and ongoing education to reinforce best practices.
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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