Batch Record Reviewer

Batch Record Review

Company - Shoolin Inc

Location: RTP, North Carolina

Duration: 6+ Months Contract

Work Arrangement: 100% Onsite

Pay Rate: $38 - $43/hr on w2

We are seeking experienced Batch Record Review / Manufacturing Documentation Specialists to support pharmaceutical manufacturing documentation and quality review activities.

Candidates with backgrounds in either Quality Assurance or Manufacturing Operations are encouraged to apply.

Key Responsibilities:

Review executed batch records for completeness, accuracy, signatures, calculations, and required attachments.

Perform batch record reviews at the desk and on the production floor, as assigned.

Review manufacturing and equipment logbooks and identify missing or inconsistent entries.

Verify scanned batch records and Component History Files against original source documents.

Check document completeness, legibility, page sequence, and correct identification.

Coordinate documentation corrections, missing pages, and rescanning activities.

Track outstanding review comments and ensure documentation packages are complete.

Required Qualifications:

Pharmaceutical manufacturing experience in QA batch review, Operations documentation review, or manufacturing documentation.

Hands-on experience reviewing batch records and GMP-controlled documents.

Familiarity with documentation discrepancy resolution and good documentation practices.

Experience with scanned records, electronic document repositories, or document verification.

Strong attention to detail and organizational skills.

Pay Rate: $38–$43 per hour on W-2, based on experience.

Benefits: Eligible employees may enroll in and receive benefits offered by Shoolin Inc., subject to applicable plan terms, eligibility criteria, and contribution requirements.

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.