Batch Record Reviewer

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.

• 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).
• Ensure discrepancies missing data or documentation errors are identified and resolved 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.
• Ensure certifications accurately reflect product specifications test/inspection results and applicable standards.
• Verify all supporting data is complete and approved prior to certification issuance.
• Able to 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.
• Any other duties assigned by supervisor.

• 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.
• Ability 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.
• Ability to speak read and write in English.

Education & Experience

• High school diploma or equivalent
• Experience in Quality or related field
• Minimum 3 years of experience in GMP

Working Conditions

• While performing the duties of this job the employee occasionally works near moving mechanical parts and is occasionally exposed to wet and/or humid conditions ambient air fumes or airborne particles.
• The noise level in the work environment is usually moderate but occasionally high requiring safety equipment to be utilized.

Physical Requirements

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Candidate must be able to 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.
• Ability to lift and carry up to 35 pounds and occasionally up to 50 pounds.

Pay: $19.00-$22.00/hour

Benefits:

Eligible after 1st day:

• Paid holidays
• Employee Assistance Program

Eligible after 90-day probation period:

• 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

Eligible after 1 year of service:

• 401(k) with Employer Match
• Potential for discretionary bonus

The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job the type of years and experience within the industry education etc.

Were proud to be an equal opportunity employer.

This means we actively pursue ways to celebrate our differences and dont discriminate based on an individuals 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.

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