3rd Shift Batch Record Auditor

Sharp Corporation; Allentown (Lehigh County); On-site; USD 42,000 - 54,000; Full time

Job summary

Sharp Packaging Services in Allentown, PA is seeking a Documentation Reviewer to support the packaging quality workflow. You will review line documentation for primary, secondary, and clinical packaging, and release work for distribution.

Responsibilities include logging documentation, addressing customer inquiries, and participating in audits. Proficiency in Microsoft Office, Adobe Acrobat, and QAD is valued.

Qualifications

• High School Diploma required; 1–2 years pharma experience preferred.
• Knowledge of FDA cGMPs and cGDPs.
• Strong documentation review and compliance skills.
• Excellent written and verbal communication.
• Strong organizational and planning abilities.
• Excellent interpersonal skills.

Responsibilities

• Review documentation for primary, secondary, and clinical packaging after reconciliation.
• Log and review documentation for errors, omissions, or overwrites per SOPs.
• Follow up on customer inquiries related to packaging documentation and compliance.
• Release final work in-process or finished product.
• Maintain QAD Item Master and Router Maintenance.
• Log packaging samples and coordinate shipment to customers.
• Maintain and file packaging documents in current status locations.
• Enter lot-specific information into Quality Dashboard.
• Participate in internal, customer, and regulatory audits.
• Other duties as required.

Skills

Microsoft Office Suite

Adobe Acrobat

QAD

Pilgrim SmartSolve

Education

High School Diploma

Tools

QAD

Pilgrim SmartSolve

Job description

Sharp Packaging Services in Allentown, PA is seeking a Documentation Reviewer to support the packaging quality workflow. You will review line documentation for primary, secondary, and clinical packaging, and release work for distribution.

Responsibilities include logging documentation, addressing customer inquiries, and participating in audits. Proficiency in Microsoft Office, Adobe Acrobat, and QAD is valued.