Job Description
Job Description Job Summary: The Quality Assurance Specialist is responsible for developing, implementing, and maintaining a cGMP Quality System to meet the requirements of 21CFR210, 21CFR211, Regulatory Agencies, and customer expectations.
Duties/Responsibilities: - Review and approve/reject all raw materials and packaging components.
- Respond to customer complaints.
- Administer/review complaint investigations.
- Review all investigations as necessary.
- Create change controls.
- Revise all packaging and manufacturing batch records.
- Review and approve monographs, specification sheets, and analysis sheets.
- Handle all quarantine shipments.
- Audit manufacturing processes.
- Review and approve new labeling.
- Coordinate recalls.
- Review warehouse temperature monitoring data and charts.
- Support and provide assistance to the Quality Assurance Manager as necessary.
- Perform investigations, determine root cause, and develop CAPAs
Required Skills/Abilities: - Excellent verbal and written communication skills in English.
- Excellent management and teamwork skills.
- Excellent organizational skills and attention to detail.
- Excellent time management skills with a proven ability to meet deadlines.
- Ability to function well in a high-paced and at times stressful environment.
- Ability to understand and follow all Standard Operating Procedures and current Good Manufacturing Practices provided by the Company.
- Understanding of quality systems including change control, deviations and CAPAs.
- Ability to handle multiple tasks concurrently and complete them in a timely manner.
- Strong written and verbal language skills to effectively read and write SOPs and related lab reports, and communicate with personnel at all levels in the organization.
Requirements Education and Experience - B.S. in Chemistry, Biology, or equivalent work experience in a related field.
- •Experience in computer software, such as Microsoft applications.
- •Expert knowledge of cGMP regulations.
- •Expert knowledge and understanding of FDA policies and regulations.
- •Pharmaceutical experience required.
Job Type: Full-time Pay: $58,000.00 - $62,000.00 per year
Ability to commute/relocate:
- Gulfport, MS 39501: Reliably commute or planning to relocate before starting work (Required)
Education:
Experience:
- Quality assurance: 3 years
- Pharmaceutical Investigations: 3 years
Benefits Benefits: - Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Job Tags
Full time, Work experience placement, Relocation,