Batch Record Reviewer
About the role
The Batch Record Reviewer is responsible for reviewing and releasing finished goods while ensuring all documentation meets Good Documentation Practices (GDP) and ALCOA+ data integrity principles.
Responsibilities
- Review batch records and travelers for completeness, accuracy, and compliance.
- Release product in accordance with internal procedures and quality standards.
- Ensure all documentation adheres to GDP standards (legible, complete, properly corrected, and signed/date).
- Confirm data integrity in alignment with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
- Identify and resolve discrepancies, missing data, or documentation errors prior to release.
- Develop deep understanding of company products including raw materials and components.
- Serve as a Subject Matter Expert (SME) for documentation requirements.
- Generate and issue Certificate of Conformance.
- Verify all supporting data is complete and approved prior to certification issuance.
- Maintain tight schedules for releases for different projects.
- Communicate effectively with Production, Engineering, and Quality teams regarding product status.
- Support Quality Control by performing inspections as needed to verify product conformance.
Requirements
- Strong understanding of GDP and ALCOA+ data integrity principles.
- Ability to interpret drawings, specifications, and quality records.
- Demonstrated ability or potential to develop product-level expertise (SME).
- Strong attention to detail and documentation accuracy.
- Able to work as a self-starter.
- Knowledge of Microsoft Excel and Word.
- Strong interpersonal and communication skills.
- Able to execute all duties and responsibilities in a safe and timely manner.
- Able to speak, read, and write in English.
Education & Experience
- High school diploma or equivalent.
- Experience in Quality or related field.
- 3-5 years of experience in GMP.
Physical Requirements
- Perform the physical responsibilities of the job utilizing arms, hands, and fingers to perform complex functions of manufacturing parts and performing other duties of the job; e.g., standing, sitting, walking throughout the facility and stairs, bending, squatting, and kneeling, etc.
- Able to lift and carry up to 35 pounds and occasionally up to 50 pounds.
Pay
$19.00-$22.00/hour
Benefits
- Paid holidays
- Employee Assistance Program
- Medical, Dental, Vision, Basic Life/AD&D Insurance
- Voluntary Term Life/AD&D Insurance
- Health Savings Account (HSA)
- Flexible Spending Account (FSA)
- Dependent Care Account
- Commuter Transportation Management Account
- Vacation time
- Sick time
- 401(k) with Employer Match
- Potential for discretionary bonus
Equal Opportunity Employer
We are proud to be an equal opportunity employer. This means we actively pursue ways to celebrate our differences and don’t discriminate based on an individual’s race (including traits historically associated with race, such as hair texture, hair type, and protective hairstyles including braids, locks, and twists), creed, national origin, nationality, religion, ancestry, age (40 or over), sex (including pregnancy), familial status, marital status, civil union or domestic partnership status, affectional or sexual orientation, gender identity or expression, mental or physical disability (including perceived disability, AIDS, and HIV status), atypical hereditary cellular or blood trait, genetic information, because of liability for service in military, status as a smoker or non-smoker, status as a registered medical marijuana user, or any unlawful criterion existing under applicable federal, state, or local laws.