Quality Specialist II

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.