Quality Assurance Specialist I (Swing Shift) PC 1512
About The Position
Your Role: This position is primarily responsible for the maintenance of quality operations and processes to assure GMP compliance for relevant operations carried out, including activities related to preclinical and clinical supplies and potentially commercial production. Essential Duties and Responsibilities: Implement and maintain quality documentation, including equipment master files, personnel training files, controlled material files, and document control files. Update specifications per current USP and EP editions. Perform quality reviews for maintenance work orders and instrument calibration assessments. Review equipment cycle and monitoring data to ensure proper operation. Perform final review of room, equipment, and facility records and associated support systems to release areas for cGMP operations. Perform review of documentation to determine release status. Approve material for release or nonconformance investigation. Approve the mechanism for isolating and/or quarantining equipment, facilities, or materials that fail to meet required specifications. Quarantine Product pending final release testing. Conduct review of batch production records and supporting batch documentation, such as quality control testing data and equipment maintenance and calibration records. Assist in investigations, when assigned, to allow for disposition of material and approve return-to-use for quarantine materials or return-to-service orders for equipment and facilities following completion of investigations. Perform QA on the floor activities with routine presence in the manufacturing area. Assist in internal compliance and external (supplier) audits as assigned. Serve as an internal interface with customers on GMP contract manufacturing projects. Able to support 24/7 process operations and shift schedule.
Requirements
- Bachelor's Degree
- 0-2 years of related experience and/or training; or equivalent combination of education and experience.
- Previous and substantial GMP experience is required, as is prior knowledge of word processing, database management, and record-keeping.
Responsibilities
- Implement and maintain quality documentation, including equipment master files, personnel training files, controlled material files, and document control files.
- Update specifications per current USP and EP editions.
- Perform quality reviews for maintenance work orders and instrument calibration assessments.
- Review equipment cycle and monitoring data to ensure proper operation.
- Perform final review of room, equipment, and facility records and associated support systems to release areas for cGMP operations.
- Perform review of documentation to determine release status.
- Approve material for release or nonconformance investigation.
- Approve the mechanism for isolating and/or quarantining equipment, facilities, or materials that fail to meet required specifications.
- Quarantine Product pending final release testing.
- Conduct review of batch production records and supporting batch documentation, such as quality control testing data and equipment maintenance and calibration records.
- Assist in investigations, when assigned, to allow for disposition of material and approve return-to-use for quarantine materials or return-to-service orders for equipment and facilities following completion of investigations.
- Perform QA on the floor activities with routine presence in the manufacturing area.
- Assist in internal compliance and external (supplier) audits as assigned.
- Serve as an internal interface with customers on GMP contract manufacturing projects.
- Able to support 24/7 process operations and shift schedule.
Benefits
- health, vision, and dental insurance
- 401(k) plan
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
