Quality Specialist II
Job Description
Ensure GMP compliance and quality verifications across Davie pharmaceutical manufacturing operations
Quality Specialist II
Location: Davie, FL
Duration: 6 months
Shift: Monday – Friday 2:00 PM – 10:30 PM EST. Able to work at least up to 2 weekends (Sat and Sun) per month.
Job Description
- Experience as a QA in a Pharmaceutical environment (direct support to Mfg Operations)
- Strong cGMP knowledge with complex process in granulation, blending, coating, printing and equipment cleaning verifications.
- Experience working independently with minimal supervision and bring the knowledge and expertise needed to improve and transform the areas.
Position Summary
- Under general supervision, monitors compliance with the current Good Manufacturing Practices and Company policies, procedures and specifications; performs visual cleaning verification of equipment and rooms.
Essential Areas Of Responsibility
- Carries out responsibilities in accordance with the organization's policies, procedures, and state, Federal and local laws.
- Conducts daily GMP walkthrough and audit
- Conduct walkthroughs of manufacturing rooms and perform AQLs – (Acceptance Quality Limits) as needed
- Place material and products on Hold.
- Review executed manufacturing records.
- Performs cleaning verifications of rooms and equipment as needed.
- Responsible for performing additional related duties as assigned.
Education/Certification/Experience
- Minimum Qualifications: High School Diploma or equivalent and two (2) years manufacturing and/or warehouse environment experience or one (1) year of satisfactory performance as QA Inspector.
Skills/Knowledge/Abilities
- Establishing and maintaining cooperative working relationships with others.
- Reading, reviewing, sampling, counting and calculating yields and reconciliations.
- Reading, understanding, interpreting and complying with current Company policies and procedures including safety rules and regulations.
- Communicating clearly and concisely, both orally and in writing.
- Operating personal computer and database software.
Monitor compliance with current Good Manufacturing Practices and company policies, procedures and specifications, Perform visual cleaning verification of equipment and rooms, Conduct daily GMP walkthroughs and audits, Place material and products on Hold and perform AQLs as needed, Review executed manufacturing records and perform cleaning verifications of rooms and equipment
