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Job Summary:
The Quality Control Specialist is responsible for the review, management, and closure of Batch Manufacturing Records (BMRs) and associated quality documentation to support compliant and timely product release. This position plays a critical role in ensuring manufacturing records are complete, accurate, and audit-ready while maintaining compliance with GMP requirements and internal quality standards.Â
The role serves as a key contributor to maintaining the Batch Manufacturing Record (BMR) review process, supporting operational efficiency, and ensuring the timely release of product to customers. The individual will work cross-functionally with Manufacturing, Quality Control, Quality Assurance, and Operations to resolve documentation issues, drive batch record closure, and support continuous improvement initiatives.
Job Duties and Responsibilities:
Batch Record Review & Closure
- Perform QC Final Review of Batch Manufacturing Records (BMRs) to verify accuracy, completeness, and compliance with GMP requirements and company procedures.
- Identify, document, and follow up on missing information, discrepancies, and documentation gaps.
- Coordinate with Manufacturing and other departments to obtain corrections and complete record documentation.
- Support timely review, closure, and maintenance of batch records within Redzone.
- Ensure batch records are audit-ready and maintained in accordance with document retention requirements.
Documentation Management
- Support the scanning, filing, organization, and interim archiving of quality documentation until archiving activities transition to Document Control.
- Maintain accurate and organized records to support inspections, audits, and regulatory requirements.
- Verify that all required supporting documents are included and properly filed.
Product Release Support
- Perform physical product reviews prior to release.
- Verify completion of required quality documentation and release criteria.
- Support product release activities to ensure adherence to quality standards and customer requirements.
Certificate of Analysis (COA) Management
- Generate and issue Certificates of Analysis accurately and within established timelines.
- Verify data and supporting documentation prior to COA approval and release.
- Maintain COA records in compliance with company procedures.
Continuous Improvement & Compliance
- Assist in identifying process improvements related to batch record review, document management, and release activities.
- Support internal and external audits, inspections, and quality system initiatives.
- Promote compliance with GMP regulations, company policies, and quality standards.
Job Requirements:
- High school diploma or GED required.
- Minimum of 2 years of experience in a Quality Control, Quality Assurance, Document Control, or Manufacturing environment.
- Experience in reviewing manufacturing documentation and batch records preferred.
- Experience working in a GMP-regulated environment preferred within dietary supplements, food, or pharmaceuticals.
- Experience with electronic manufacturing or quality systems, including Redzone, is a plus.
- Hands-on experience reviewing batch records and supporting manufacturing operations.
- Proven ability to perform root cause analysis and implement practical corrective actions.
- Effective communication and documentation skills.
- Ability to lift 25 lbs and perform standard physical duties in the workplace.
Required Skills & Competencies
- Strong attention to detail and data accuracy.
- Excellent organizational and documentation management skills.
- Strong written and verbal communication skills.
- Ability to manage multiple priorities and meet deadlines.
- Proficiency in Microsoft Office applications.
- Strong problem-solving and follow-up skills.
- Ability to work independently and collaboratively across departments.
Monday-Friday, 8:00am-5:00pm
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