Job Description
Job DescriptionJob Title: Quality Specialist II
Job Location: Davie, FL
Job 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.
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