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Quality Assurance Associate (IPQA)

Appco Pharma LLC
Piscataway, NJ Full Time
POSTED ON 12/12/2024 CLOSED ON 1/10/2025

What are the responsibilities and job description for the Quality Assurance Associate (IPQA) position at Appco Pharma LLC?

The IPQA Associate plays a key role in ensuring compliance with Current Good Manufacturing Practices (cGMP) during manufacturing and packaging processes. This position involves monitoring and verifying in-process activities, ensuring products meet quality standards, and maintaining accurate documentation throughout production.


Responsibilities

  • To ensure, In process Quality assurance checks.
  • Equipment, area/ room and line clearances for manufacturing and Packaging.
  • Collection and maintenance of reserve samples per approved documents.
  • Verification of documentation and sampling of incoming materials, in-process samples, finished products and stability samples.
  • Issuance of batch records and formats.
  • Assigning of batch numbers to batch records.
  • Follow cGMP and cGDP practices.
  • Review Batch Records to ensure compliance documents are correct prior to product release.
  • Report and handle any deficiencies observed in work.
  • Follow day-to-day instructions provided by the supervisor.
  • Adherence to the instructions of SOP, protocols or Batch records. 


Qualifications

  • Associate degree OR a minimum of 6 months of related experience (Quality Associate; Document Control/ Record Review/ Quality Control)
  • Excellent verbal and written communication skills
  • Proficient with Microsoft Excel, Word, Access, and Outlook
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