Batch Records Writer
Boston
Contract
Negotiable
Compliance
CR/581549_1772124620
Batch Records Writer
Production Batch Records Writer (Contract)
Contract Length: 2 months
Hours: Full‑time (40 hours per week)
Work Setup: Remote
About the Role
A confidential organisation in the chemical/pharmaceutical sector is seeking an entry‑level Production Batch Records Writer to support the consolidation, authoring, and completion of drug‑substance batch records. This contract role is ideal for someone with hands‑on GMP experience and a basic understanding of batch documentation within chemical or pharmaceutical operations.
You will be responsible for writing, organizing, and finalising batch records and related instructions to address recent findings and strengthen overall documentation quality. The expectation is to complete one batch record per week within the standard 40‑hour working schedule.
Key Responsibilities
- Author, revise, and consolidate drug‑substance batch records in alignment with GMP standards.
- Translate operational and process data into clear, accurate, compliant documentation.
- Address documentation improvements related to recent findings.
- Ensure all record sections and instructions are complete, audit‑ready, and compliant.
- Collaborate remotely with Quality and Production teams when clarification is needed.
- Deliver completed batch records on time, targeting one batch per week.
- Maintain consistency, structure, and accuracy across all documentation produced.
Required Qualifications
- 1-2 years of hands‑on GMP experience (required).
- Experience working with batch records, ideally in drug‑substance or chemical processing environments.
- Basic understanding of chemical production workflows.
- Excellent attention to detail and adherence to documentation standards.
- Ability to work independently in a remote setting while meeting deadlines.
Nice-to-Have
- Experience writing instructions, SOPs, or other GMP‑controlled documents.
- Exposure to QARA‑related documentation processes.
- Familiarity with chemical process data and parameters.
Contract & Compensation
- 2‑month contract.
- 40 hours per week with delivery expectation of one batch record weekly.
- W2 workers only
