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.
- · 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:
- Bachelor's (Preferred)
Experience:
- Quality assurance: 3 years
- Pharmaceutical Investigations: 3 years
Benefits
Benefits:
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Skills Required
- B.S. in Chemistry, Biology, or equivalent work experience in a related field.
- Expert knowledge of cGMP regulations.
- Expert knowledge and understanding of FDA policies and regulations.
- 3 years of quality assurance experience.
- 3 years of pharmaceutical investigations experience.
What We Do
Allen Spolden specializes in clinical research operations management and provides tailored workforce solutions for clinical research organizations, pharmaceutical, biotech, and healthcare sectors. They offer services in clinical research, data management, regulatory affairs, and talent acquisition.
