Batch Record Coordinator I (Entry-Level)
Department
Manufacturing Operations / Quality Systems
Location
[Company Location]
Position Summary
The Batch Record Coordinator I is responsible for supporting the creation, review, issuance, reconciliation, and archival of manufacturing batch records and associated GMP documentation within a biopharmaceutical manufacturing environment. This entry-level role ensures documentation accuracy, completeness, and compliance with Good Manufacturing Practices (GMP), company procedures, and regulatory requirements. The position works closely with Manufacturing, Quality Assurance, Quality Control, Supply Chain, and Document Control teams to maintain documentation integrity throughout the production lifecycle.
Key Responsibilities
- Prepare, issue, track, and reconcile batch production records and manufacturing documentation.
- Review completed batch records for accuracy, completeness, legibility, and compliance with GMP requirements.
- Identify documentation discrepancies, missing information, or errors and coordinate resolution with appropriate departments.
- Support document control activities, including filing, scanning, archiving, and retrieval of GMP records.
- Maintain controlled documentation in electronic and paper-based quality systems.
- Assist with batch record revisions and updates under established change control procedures.
- Ensure timely processing and routing of manufacturing documentation for review and approval.
- Support manufacturing operations by providing controlled copies of approved procedures, forms, and records.
- Participate in investigations related to documentation errors and support corrective action implementation.
- Track documentation metrics and maintain records of batch record status.
- Follow data integrity principles and ensure compliance with company policies and regulatory requirements.
- Support internal audits, regulatory inspections, and quality assessments by providing documentation as requested.
- Maintain a clean, organized, and inspection-ready documentation environment.
- Perform other administrative and documentation-related duties as assigned.
Required Qualifications
- Associate's or Bachelor's degree in Life Sciences, Biology, Biotechnology, Chemistry, Pharmaceutical Sciences, Engineering, or a related field.
- 0–2 years of experience in biotechnology, pharmaceutical manufacturing, quality, laboratory, or regulated industry environments.
- Basic understanding of GMP, GDP (Good Documentation Practices), or regulated documentation requirements preferred.
- Proficiency with Microsoft Office Suite (Word, Excel, Outlook).
- Strong attention to detail and organizational skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple tasks and meet deadlines in a fast-paced environment.
- Ability to work independently and collaboratively within cross-functional teams.
Preferred Qualifications
- Internship, co-op, or academic experience in biotechnology, pharmaceuticals, medical devices, or other regulated industries.
- Familiarity with document management systems, ERP systems, or electronic batch record systems.
- Knowledge of FDA, EMA, or ICH regulatory requirements is a plus.
- Experience reviewing technical or quality documentation is desirable.