QA Associate, Batch Records

PeopleShare by PROMAN

Moorestown Township (NJ)

On-site

USD 25,000 - 36,000

Full time

9 days ago

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Job summary

PeopleShare is seeking a detail-oriented Quality Technician - Batch Records to join a growing pharmaceutical organization in Moorestown, NJ. This position plays a critical role in ensuring compliance with GMP (Good Manufacturing Practices) and supporting the preparation of clinical supplies through the review, approval, and auditing of batch record documentation.

If you have experience working in a GMP-regulated environment, strong documentation skills, and an exceptional eye for detail, we want

Qualifications

  • Experience in GMP-regulated environments or pharmaceutical manufacturing is preferred.
  • Strong documentation and record-keeping abilities.
  • Excellent written and verbal communication skills.
  • Proficiency with Microsoft Office Suite (Excel, Word, Outlook, Access).
  • Ability to work in a fast-paced, detail-oriented setting and manage multiple priorities.

Responsibilities

  • Maintain work areas in GMP-compliant condition.
  • Review and approve batch-record related documentation (unexecuted batch records, packaging samples, material specs, label batch records, change controls).
  • Verify client approval of reviewed documentation.
  • Audit and release Executed Batch Records (EBRs).
  • Collaborate with Packaging and Quality Control teams to resolve discrepancies.
  • Provide guidance to packaging staff to improve documentation quality and compliance.
  • Maintain document control procedures and records; assist with SOPs and data collection forms.
  • Enter and verify data in the Inventory Control System (ICS) and create/revise controlled documents in ZenQMS.
  • Support client and regulatory audits as required.

Skills

Attention to detail
Communication skills
Interpersonal skills
Multitasking
Analytical skills

Education

Bachelor's degree or equivalent combination of education and experience

Tools

Microsoft Office

Job description

Quality Technician - Batch Records

PeopleShare | Moorestown, NJ 08057

Pay: $22/hour
Schedule: Monday - Friday, 8:00 AM - 4:30 PM
Duration: 4-Month Temp-to-Hire

Join a Leading Pharmaceutical Company in Moorestown, NJ!

PeopleShare is seeking a detail-oriented Quality Technician - Batch Records to join a growing pharmaceutical organization in Moorestown, NJ. This position plays a critical role in ensuring compliance with GMP (Good Manufacturing Practices) and supporting the preparation of clinical supplies through the review, approval, and auditing of batch record documentation.

If you have experience working in a GMP-regulated environment, strong documentation skills, and an exceptional eye for detail, we want to hear from you!

Key Responsibilities
  • Maintain work areas in compliance with GMP standards.
  • Review and approve proposal-related documentation, including:
    • Unexecuted batch records
    • Packaging samples
    • Material specifications
    • Label print batch records
    • Batch record change controls
    • Additional quality documents as needed
  • Verify client approval of reviewed and approved proposal documentation.
  • Audit and release Executed Batch Records (EBRs).
  • Partner with clients to resolve documentation-related issues.
  • Work closely with Packaging and Quality Control teams to investigate and correct batch record discrepancies.
  • Provide guidance and support to packaging personnel to improve documentation quality and compliance.
  • Maintain document control procedures and records.
  • Assist with the creation, revision, and review of SOPs, work instructions, and data collection forms.
  • Enter and verify data within the Inventory Control System (ICS).
  • Create and revise controlled documents in ZenQMS.
  • Support client and regulatory audits as required.
Qualifications
  • Bachelor's degree or equivalent combination of education and experience.
  • Previous experience in packaging, pharmaceutical manufacturing, or quality assurance preferred.
  • Knowledge of cGMP regulations and documentation practices.
  • Experience working in a GMP-regulated environment highly preferred.
  • Familiarity with pharmaceutical industry processes and quality systems.
  • Strong attention to detail and organizational skills.
  • Excellent written and verbal communication skills.
  • Strong interpersonal and problem-solving abilities.
  • Proficiency with Microsoft Office Suite, including Excel, Word, Outlook, and Access.
  • Strong mathematical and analytical skills.
  • Ability to manage multiple priorities in a fast-paced environment.
Why Apply?
  • Opportunity to gain experience with a respected pharmaceutical company.
  • Hands-on exposure to GMP quality systems and batch record review processes.
  • Competitive pay at $22/hour.
  • Potential for permanent hire after the contract period.
  • Consistent weekday schedule with work-life balance.
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