Batch Records Compliance Specialist

Sharp Services, LLC; Macungie (Lehigh County); On-site; USD 52,000 - 76,000; Full time

Job summary

Sharp Services, LLC seeks a Documentation Reviewer to ensure packaging documentation complies with regulatory standards and customer specs. You will review line documents, log issues, and release product batches for distribution to support quality and compliance goals.

The role requires strong attention to detail, knowledge of cGMPs, and experience with QA processes. Proficiency in MS Office, Adobe Acrobat, QAD, and Pilgrim SmartSolve is expected.

Qualifications

• Knowledge of FDA regulations related to cGMPs.
• Understanding of cGDPs and quality control/assurance.
• Attention to detail in documentation review and compliance.
• Strong written and oral communication skills.
• Ability to work with audits and regulatory inquiries.

Responsibilities

• Review documentation for primary, secondary, and clinical packaging after reconciliation.
• Log and review documentation for errors, omissions, and compliance with cGMPs and customer specs.
• Follow up on customer inquiries related to packaging documentation and testing.
• Perform final release of in-process or finished product.
• Maintain QAD Item Master and Router Maintenance records.
• Log and manage packaging samples and coordinate their shipment.
• Maintain and file documentation in current status locations.
• Enter lot-specific information into the Quality Dashboard.
• Participate in internal, customer, and regulatory audits as needed.
• Perform other related duties as required.

Skills

Regulatory compliance

cGMP knowledge

Document control

QA auditing

Detail-oriented

Written & verbal communication

Interpersonal skills

Education

High School Diploma

Tools

Microsoft Office

Adobe Acrobat

QAD

Pilgrim SmartSolve

Job description

Sharp Services, LLC seeks a Documentation Reviewer to ensure packaging documentation complies with regulatory standards and customer specs. You will review line documents, log issues, and release product batches for distribution to support quality and compliance goals.

The role requires strong attention to detail, knowledge of cGMPs, and experience with QA processes. Proficiency in MS Office, Adobe Acrobat, QAD, and Pilgrim SmartSolve is expected.