Job Title: Batch record Reviewer

Reports To: Quality Manager / Document Control Supervisor

Group/Division: Laboratory Products Group/Laboratory Equipment Division

Career Band: 2 - 3

Job Track: Professional

Position Location: Marietta, OH

Number of Direct Reports: None

FLSA Status: Non-Exempt

Position Summary:

Facilitate the management and improvement of quality records created and maintained by the Marietta Manufacturing Center of Excellence. Measure and report operational performance on GDP compliance. Perform other related duties as assigned by the Quality Manager / Document Control Supervisor.

Key Responsibilities:

• Identify, error-check, log and file documents critical to GMP compliance.
• Inspect, measure and report GDP performance of reviewed records.
• Provide guidance and training to coworkers as it relates to GDP.
• Lift up to 20lbs unassisted, unpackage / repackage materials.
• Serve as a critical function in facilitating internal and external audits of the facility by retrieving, reviewing, and copying records as needed.
• File records (electronic or hard-copy) in designated locations, retrieve as necessary to support the business.
• Performs all job duties within ISO standards, regulatory or statutory requirements. At Thermo Fisher Scientific, quality is inherent in all that we do, earning our Customers’ loyalty through their trust in our products and services. All employees are required to understand and adhere to site quality requirements, stemming from ISO 13485, and any other applicable regulatory requirements (e.g. FDA CFR). Employees will undergo Quality training during onboarding and annually through our internal learning management system
• Demonstrate continual self-improvement.

Minimum Requirements/Qualifications:

• 2 years experience in Quality Systems, document control administration is desired.
• Unwavering attention to detail, able to identify GDP errors.
• Ability to work alone or in a team, complete routine tasks on-time with minimal oversite.
• Strong verbal and written communication skills are required.

• Proficient in use of Microsoft Office Suite.
• Working experience with Good Manufacturing Practices, FDA, ISO 13485 and Good Documentation Practices is advantageous.