Technical Writer

New Jersey

Process Alliance
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About the Role

We're looking for a detail-oriented and process-focused Entry-Level Batch Record Reviewer to join our pharmaceutical manufacturing team. This role is ideal for someone with strong organizational skills and technical writing ability, or a junior chemical engineering background looking to build experience in a regulated industry.

Key Responsibilities

  • Review completed batch production records for accuracy, completeness, and compliance with Good Manufacturing Practices (cGMP).
  • Identify and document discrepancies, deviations, or incomplete information in batch records.
  • Work cross-functionally with manufacturing, quality, and document control teams to ensure timely resolution of issues.
  • Support efforts to streamline and improve batch documentation processes.
  • Ensure proper filing and archival of reviewed records in compliance with company procedures.
  • Follow standard operating procedures (SOPs) and work instructions related to batch record review.

Qualifications

  • Bachelor's degree in a technical field (e.g., Chemical Engineering, Life Sciences, Technical Writing) is preferred but not required.
  • Strong attention to detail and ability to spot inconsistencies in technical documents.
  • Effective written and verbal communication skills.
  • Comfortable working in a fast-paced, team-oriented environment.
  • Basic proficiency in Microsoft Office applications (Word, Excel, Outlook).

Bonus Skills (Not Required)

  • Exposure to GMP environments or production documentation.
  • Experience with batch records, SOPs, or compliance-related work.

Date Posted: 02 May 2025
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