Demo

Quality Control Analyst

Barrington James
River, MA Full Time
POSTED ON 1/13/2025
AVAILABLE BEFORE 4/2/2025

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!

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