Job Title: Quality Systems Associate

Job Description

• Ensure compliance to cGMP standards in the Manufacturing and Packaging areas. • Compile and ensure all production control records are complete and accurate. • Confirm that all Laboratory Services release testing meets bulk and finished product specifications. • Execute or coordinate the resolution of excursions identified during the batch review process. • Issue and review logbooks and notebooks. • Compile, organize, and review documentation from customers, Manufacturing, Packaging, and Laboratories. • Adhere to customer release requirements. • Update and maintain paper and electronic records. • File and archive documentation.

Hard Skills

• Ensure company-wide adherence to cGMP standards
• Ensure compliance to cGMP standards in Manufacturing and Packaging
• Compile and ensure accuracy of production control records
• Confirm satisfactory conformance of Laboratory Services release testing
• Execute or coordinate resolution of batch review process excursions
• Issue and review logbooks and notebooks
• Compile, organize, and review documentation
• Adhere to customer release requirements
• Update paper and electronic records
• File and archive documentation

Job Type

This is a Contract-to-Hire position with a duration of 4 Month(s).

Work Site

This is a fully on-site position in Mainland, Pennsylvania.

Work Environment

Will be split between office environment, packaging, and lab. Team of 6 members: currently 2 on first shift (seeking to add a 3rd), and 3 on second shift. Hours: 8am-5pm (M-F) with a 1-hour unpaid lunch.