Vacancy expired!
- Perform product inspection for defects, leaks and particulates.
- Perform environmental monitoring of personnel (as needed) and complete documentation.
- Assist in the manufacturing validations
- Perform document review of activities such as cleaning records, line clearance forms and inventory sheets:
- Verify that raw materials meet specification
- Verify and account for labeling
- Review temperature and BMS alarms
- Verify that product test results meet specification limits
- Verify that all documentation is complete
- Document non-compliance and work with supervisor/lead if further investigation is needed
- Submit samples to the appropriate lab for particulate identification or microbial analysis.
- Assist with equipment calibration program and maintenance record files.
- Assist with raw material release and movement.
- Under the direction of supervisor/lead, document and initiate quality events for deviation and complaint investigations.
- Support internal & external audits.
- Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).
- Participate in Quality Manager's staff meetings
- Minimum of High School Diploma/GED with work experience
- Minimum of 2 years' experience in a quality or manufacturing department of a pharmaceutical, Medical Device or related industry - OR a recent AAS/BS science graduate without industry experience
- Experienced in laboratory or aseptic operations.
- Experience within a regulated environment
- Associates/BS Degree in a scientific discipline (Biology, Microbiology, Chemistry) and no industry experience is also encouraged to apply
Vacancy expired!