Quality Assurance Specialist
7 days ago
Kindeva Drug Delivery is a leading global contract developer and manufacturer (CDMO) with expertise in delivery platform technologies. We partner with our customers to improve patient outcomes worldwide.
Job Responsibilities- Conduct audits of aseptic processes to ensure conformance to established specifications, procedures, cGMPs, and FDA regulations.
- Identify and communicate non-conformances to the QA Manager or Supervisor.
- Develop and maintain procedures, identifying gaps and updating as needed.
- Ensure adequate coverage for APA and Grade D/CNC areas.
- Lead monthly In Process Batch Record Reviews.
- Act as the QA Floor point of contact for QA and Production Management.
- Train Floor Quality Assurance colleagues.
- Perform in-process reviews of production batch records for accuracy and conformance.
- Conduct inspection readiness walk-throughs, line clearance, in-process checks, and verifications in support of manufacturing activities.
- Work in a Grade A/B classified area, completing aseptic gowning qualification and adhering to aseptic techniques and behavior.
- Generate daily written shift reports for Quality and Production Management.
- Initiate events in QTS per SOP-QLA-MQA-00720, as applicable.
- Perform PRISM transactions, as applicable.
- High School degree required; Bachelor's degree in a scientific discipline preferred.
- Minimum of 3 years of related experience and/or successful completion of a job-specific training program or equivalent combination of education and experience recommended.
The employee is occasionally exposed to work near moving mechanical parts and is required to stand, use hands to finger, handle or feel, reach with hands and arms, climb or balance, walk, sit, and talk or hear. The employee must occasionally lift and/or move up to 25 pounds and don a full body garb suit, hood, mask, goggles, and gloves for several hours at a time.
Working ConditionsThe employee must have schedule flexibility, depending on the production schedule, and be willing to work overtime, off-shifts, weekends, and/or holidays. The position requires regular onsite attendance and the ability to work effectively under and manage to strict production, time, and performance deadlines.
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