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Quality Specialist II

Integrated Resources

Job 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.
#sczr2
Vacancy posted 3 days ago
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