The Quality Assurance Technician 2nd Shift (2:30 pm to 11:00 pm) is responsible for assuring the consistent quality of production by supporting and enforcing current good manufacturing practice (cGMP) systems. The QA Technician 2nd Shift will work with the manufacturing team to ensure documentation is performed on produced material prior to release. This position will represent the Quality Organization on the 2nd shift.
- Possess knowledge of cGMP regulatory standards
- Organize and maintain physical and electronic versions of batch and lot records
- Support product inventory maintenance: adding new products, reviewing requests for dispensing/release of product and documenting the transactions
- Support inventory cycle counts
- Issue batch records per project or product specifications and ensures compliance according to the procedures and documentation requirements.
Skills:
- 2+ years in a QA role, preferably in a pharmaceutical/nutraceutical environment
- FDA/cGMP experience with pharmaceutical, medical device, or other regulated industry such as food, aerospace or automotive highly preferred
- GMP, GCP or GLP experience in an ISO certified company preferred
- Ensures and supports compliance with all associated quality procedures, control plans and quality management system requirements
- Maintains good documentation practices involving all aspects of the manufacturing operation
- Maintains quality traceability information
- Proficient verbal and written communication skills
Education/Experience:
- Bachelor’s Degree in Biology, Chemistry, or a related technical field
Principals only. Recruiters, please don’t contact this job poster. Do NOT contact us with unsolicited services or offers.