What are the responsibilities and job description for the Quality Assurance Specialist position at Focus Laboratories?
Job Overview FOCUS Laboratories is seeking a quality professional with work experience in FDA r egulated l ife s cience industries to perform the duties of Quality Assurance Specialist in our Palm Harbor, FL laboratory. This position requires a firm understanding of FDA current Good Manufacturing Practices as defined in 21CFR210 and 211. Th is position reports to the Director of Quality Assurance in our Allentown Laboratory, and will be the lead quality assurance contact in Florida .
Responsibilities :
- Provides timely review of laboratory data generated for client s' drugs and devices for technical appropriateness and compliance to cGMP and GDP requirements.
- Authors stability protocols for client approval, detailing storage conditions, pull intervals, tests per pull, pass fail criteria per test, and samples quantities required per pull and per sample .
- Collaborates with operational and administrative staff on the implementation, maintenance, and improvement of quality systems.
- Ensures laboratory adherence to ISO / IEC 17025 accreditation and expands accreditation to new tests and locations at the direction of management as services expand.
- Serves as host during client and regulatory audits . Audit host schedule s site visit, prepare s for the visit, accompanies the tour of the lab, retrieve s relevant documentation takes notes and leads the response.
- Assists in the review, approval, and maintenance of all Quality Agreements and confirms FOCUS adherence to same
- Assists in the appropriate archiving of all test data for five years or for the period required by clients in specific Quality Agreements , and assures ready retrieval for review from archive if needed.
- Reviews OOS, Deviation and CAPA investigations for completeness, appropriateness and cGMP compliance.
- Conducts internal audits of the laboratory and its systems to confirm compliance with US FDA cGMP regulations and trends.
- Conducts external audits of FOCUS subcontractors, to confirm compliance with FOCUS needs, including cGMP compliance.
- Attends professional seminars, engages in correspondence with others in similar Quality Assurance positions.
- Provides leadership by example, promoting and enforcing company 's quality cultu re.
Skills :
Salary : $65,000 - $95,000