3rd Shift Batch Record Reviewer — Quality & Compliance

Sharp Clinical Services; Allentown (Lehigh County); On-site; USD 55,000 - 85,000; Full time

Job summary

Sharp Clinical Services is seeking a Documentation Reviewer to ensure accuracy of packaging documentation and regulatory compliance. This on-site role focuses on review, logging, and final release of products.

Responsibilities include maintaining QA records, auditing documentation, and addressing customer inquiries related to packaging and compliance. A High School Degree with 1–2 years pharma experience is required, with strong attention to detail and communication skills.

Qualifications

• High School Degree required; 1–2 years pharma experience preferred.
• Strong knowledge of FDA/cGMP regulations and quality control/assurance.
• Excellent documentation, communication, and organizational skills.

Responsibilities

• Review documentation for primary, secondary, and clinical packaging after reconciliation.
• Log and log defects for errors, omissions, overwrites and cGMP compliance.
• Follow up on customer inquiries related to packaging documentation and compliance.
• Perform final release of work-in-process or finished product.
• Maintain QAD Item Master and Router Maintenance.
• Log and maintain packaging process samples and coordinate shipment to customers.
• Enter lot-specific information into Quality Dashboard.
• Participate in internal, customer, and regulatory audits.
• Other duties as required.

Skills

Detail-oriented

Written & verbal communication

Organizational skills

Interpersonal skills

Quality systems knowledge

Education

High School Degree

Tools

Microsoft Office

Adobe Acrobat

QAD

Pilgrim SmartSolve

Job description

Sharp Clinical Services is seeking a Documentation Reviewer to ensure accuracy of packaging documentation and regulatory compliance. This on-site role focuses on review, logging, and final release of products.

Responsibilities include maintaining QA records, auditing documentation, and addressing customer inquiries related to packaging and compliance. A High School Degree with 1–2 years pharma experience is required, with strong attention to detail and communication skills.