We are currently seeking a highly motivated Quality Assurance (QA) Analyst to join a dynamic pharmaceutical quality team. This is an excellent opportunity for a skilled professional with experience in a GMP pharmaceutical manufacturing environment.
Key Responsibilities:
- Perform in-process testing (e.g., weight, thickness, hardness, disintegration, friability) in accordance with manufacturing batch record instructions.
- Conduct room and equipment checks prior to each manufacturing stage, ensuring compliance with detailed written procedures.
- Execute acceptable quality limit (AQL) sampling and inspections as needed.
- Inspect in-process and finished product samples for the QC Lab and follow documentation procedures to deliver results.
- Maintain records of standard weights and verify balances on a daily basis.
- Ensure the proper isolation of rejected materials during batch processes and maintain accountability in batch records.
- Monitor facility and product environmental operating conditions.
- Review engineering records, such as temperature and humidity data, calibration, PM records, pest control records, and contractor-related functions.
- Assess online batch records for completeness, proper entries, and reconciliation/yields before initiating the next processing step.
- Verify functionality of equipment and associated controls during batch runs.
- Perform testing and prepare reports for customer complaints.
- Identify and report any non-conformances or discrepancies to management.
- Participate in project work and other duties as assigned by management.
Education and Experience Qualifications:
- Minimum high school diploma required; advanced vocational training or education in pharmaceutical manufacturing, industrial management, or a related field is preferred.
- At least three (3) years of experience in quality assurance within a GMP pharmaceutical manufacturing environment.
- Experience in MDI (Metered Dose Inhalers) or parentals is preferred.
Knowledge, Skills, and Abilities:
- Proficiency in Microsoft Office tools, SAP, and other business applications.
- Strong ability to influence decision-making and facilitate the completion of work aligned with business goals.
- Excellent interpersonal and team collaboration skills.
- Proficiency in English, including spelling, grammar, and punctuation.
- Strong knowledge of current Good Manufacturing Practices (cGMP).
- Exceptional attention to detail and organizational skills.
- Ability to multitask and meet deadlines in a fast-paced environment.
- A self-starter with initiative to seek additional training or direction as needed.
If you have the required experience and are ready to take the next step in your career, apply today and join a team committed to delivering high-quality pharmaceutical products!