Batch Records Specialist: Compliance & Product Release

Sharp Corporation; Macungie (Lehigh County); On-site; USD 42,000 - 66,000; Full time

Job summary

Sharp Packaging Services seeks a detail‑oriented documentation reviewer to ensure packaging records meet cGMP and customer specifications. You will review primary, secondary, and clinical packaging docs, log issues, and support release of in‑process and finished products.

Responsibilities include auditing QAD item and router maintenance, handling inquiries from customers, and preparing quality documentation for internal and external audits. Strong MS Office and Adobe Acrobat skills are essential.

Qualifications

• High School Degree is required.
• 1–2 years pharmaceutical documentation experience preferred.
• Knowledge of FDA regulations related to cGMPs.
• Attention to detail essential for documentation review.
• Strong written and oral communication skills.
• Good organizational and planning abilities.
• Interpersonal skills for cross-functional collaboration.
• Experience with QA systems (QAD) a plus.

Responsibilities

• Review documentation related to primary, secondary, and clinical packaging.
• Log and log documentation for errors, omissions, and compliance.
• Follow up on customer inquiries related to packaging documentation.
• Release work in-process or finished product.
• Maintain QAD Item Master and Router Maintenance.
• Log and maintain packaging samples and coordinate shipment to customers.
• File packaging documentation in current status locations.
• Enter lot-specific information into the Quality Dashboard.
• Participate in internal, customer, and regulatory audits.

Skills

Attention to detail

Written & verbal communication

Organizational skills

Problem solving

Education

High School Diploma

Tools

Microsoft Office

Adobe Acrobat

QAD

Job description

Sharp Packaging Services seeks a detail‑oriented documentation reviewer to ensure packaging records meet cGMP and customer specifications. You will review primary, secondary, and clinical packaging docs, log issues, and support release of in‑process and finished products.

Responsibilities include auditing QAD item and router maintenance, handling inquiries from customers, and preparing quality documentation for internal and external audits. Strong MS Office and Adobe Acrobat skills are essential.