Job Description:
• The Quality Assurance Associate I is responsible for contributing to the oversight of key functional, tactical, and operational aspects within Quality Assurance at the Company CAM facility.
• The Quality Documentation Associate I responsibilities include, but are not limited to:
1. An Associate I is responsible for supporting key functional, tactical, and operational aspects of the Quality Assurance department.
2. An Associate I should possess a fundamental understanding of the Company Quality Systems and apply it in their daily support functions.
3. Additional responsibilities include ensuring adherence to all regulatory licenses and regulations, review/approval of GMP procedures, protocols and reports, support the development and performance of GxP Quality systems-related training, participate in internal/external compliance audits.
4. Interfacing with key Quality, manufacturing, and PO&T customers.
5. The Associate I will also support the Quality Management for activities related to archiving, imaging, and maintaining archived documents.
6. The Associate I should have a working knowledge of Library Sciences and be able to work computerized data management systems.
Job Responsibilities
• Utilizing Library Sciences maintain QA archive room, to include routine scanning, cataloging and filing of Quality Controlled data and documents.
• Coordinate shipping of records to and from offsite storage facilities.
• Work within an electronic document management system to review and provide final Quality approval of Standard Operating Procedures, Master Production Records, Solution Lot Records and other related GMP records. Perform the issuance and printing of quality controlled documents effectively and efficiently ensuring customer needs and schedules are maintained.
• Provide Quality Assurance representation and guidance at Technical Transfer meetings for manufacturing campaigns. Provide technical assistance to manufacturing operations as related to compliance requirements.
• Support the inspection documentation room activities during regulatory agency inspections; to include assembling, printing, tracking and refiling/archiving of all documentation requests.
• Supports and/or assists in GxP quality systems-related training.
• Responsible for scanning, archiving and shipping of GxP documentation and data.
• Responsible for providing final review of GxP documents in support of the Pharmaceutical Operation and Technology business unit.