Administrative Skills, Communication Skills, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Collection, Detail Oriented, Document Management, Documentation, GMP (Good Manufacturing Practices), High School Diploma, Maintain Compliance, Manufacturing, Manufacturing Operations, Multitasking, Office Management, Operational Support, Operations Management, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Production Support, Quality Management, Quality Metrics, Record Keeping, Standard Operating Procedures (SOP), Support Documentation, Team Player, Time Management, Vendor/Supplier Management, Writing Skills
Batch Record Coordinator
Join our team as a Batch Record Coordinator and play a critical role in supporting GMP manufacturing operations. This position is responsible for preparing, reviewing, and maintaining batch records and controlled documentation to ensure accuracy, compliance, and operational efficiency. The ideal candidate is highly organized, detail-oriented, and thrives in a fast-paced environment where quality and compliance are top priorities.
Key Responsibilities
- Review batch records and manufacturing documentation for completeness, accuracy, and compliance with GMP and ALCOA principles.
- Prepare, issue, reconcile, and maintain controlled forms and batch production records used in manufacturing.
- Compile and organize data for investigations, quality events, corrective actions, and batch history records.
- Coordinate document revisions, approvals, distribution, and filing activities.
- Prepare manufacturing training packets and supporting documentation.
- Assemble and maintain batch record binders, labels, and production documentation.
- Track and maintain documentation quality metrics and Right First Time (RFT) performance indicators.
- Support manufacturing planning activities and collaborate with cross-functional teams to resolve documentation-related issues.
- Revise SOPs, batch production records, reports, and other controlled documents as needed.
- Perform general administrative duties, including filing, copying, scheduling, and office supply management.
- Follow all company policies, procedures, and cGMP requirements.
- Support the Senior Document Coordinator and assist with additional projects as assigned.
Qualifications
- High school diploma or GED required; additional administrative, clerical, or manufacturing experience preferred.
- Strong attention to detail and commitment to accuracy.
- Excellent organizational, written, and verbal communication skills.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Sense of urgency and strong problem-solving skills.
- Experience working in a regulated environment is a plus.
Compensation
The pay range for this position is $18.00 - $21.00 per hour, depending on experience, qualifications, and overall fit for the role.
Why Join Us?
We offer comprehensive benefits, career growth opportunities, and a collaborative work environment where your contributions directly support the production of high-quality products. This is an excellent opportunity for someone looking to build a long-term career in manufacturing documentation, quality systems, or biopharmaceutical operations.
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Kinetic Personnel Group
BUSINESS NEVER STOPS.
Kinetic Personnel Group provides you with a single point of contact to ensure efficiency and keep your business moving. One call gets the job done, so you can stay focused on what matters most.
The people working behind the scenes on your projects are subject matter experts who focus solely on their area of expertise. They actively cultivate a network of passive and active candidates, to create quick, accurate and lasting employment matches.
500 to 999 employees
Staffing/Employment Agencies
http://www.kineticpersonnelgroup.com/