QA Documentation & Batch Records Specialist

Regulatory Jobs; Lower Providence Township (PA); Sur place; USD 52 000 - 76 000; Plein temps

Résumé du poste

Globus Medical is seeking a Quality Assurance Reviewer to join the QA Operations team to review device and product records and ensure compliance with release criteria. The reviewer will also ensure documents are scanned and logged into the electronic record system.

Responsibilities include batch record review, COA/test report review, and maintaining accurate records while adhering to SOPs and regulatory requirements.

Qualifications

• Minimum of one year experience with document review.
• Familiarity with GMP and SOPs to ISO standards is a plus.
• Strong organizational and time-management skills.

Responsabilités

• Performs batch record review and release functions.
• Reviews certificates of compliance or test reports.
• Reviews receiving inspection documentation.
• Reports non-conformances and discrepancies.
• Generates Excel spreadsheets to record review activities.
• Ensures that finished batch records are scanned and logged into the electronic record system.

Connaissances

MS Excel

Document review

Attention to detail

Formation

High School Diploma

Outils

MS Office

Description du poste

Globus Medical is seeking a Quality Assurance Reviewer to join the QA Operations team to review device and product records and ensure compliance with release criteria. The reviewer will also ensure documents are scanned and logged into the electronic record system.

Responsibilities include batch record review, COA/test report review, and maintaining accurate records while adhering to SOPs and regulatory requirements.