Work Schedule
Flex Shifts, 40 hrs/wk
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) and Safety Standards. Cleanroom protocols: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc. allowed. Office environment and some PPE (Personal Protective Equipment) required, including safety glasses, gowning, gloves, lab coat, ear plugs, etc.
Job Description
* Perform batches of the manufactured commercial batches and prepare release documents for QP approval.
* Conduct Statistical Control (AQL) activities downstream of inspection for products in the DPS & PDS areas.
* Train personnel involved in quality activities.
* Support investigation teams in handling quality issues of batches for clinical and commercial use by identifying corrective and preventive actions.
* Collaborate on CAPAs management resulting from quality investigations, verifying their effectiveness over time.
* Participate in initiatives/projects aimed at Operational Excellence.
* Attend all meetings related to new and ongoing projects.
* Coordinate technical and management meetings with customers.
* Support during client/quality inspections (Audits) and internal/regulatory inspections.
* Generate reports on quality events.
* Contribute to achieving quality objectives related to job responsibilities, including RFT, Deviation Rate, Past due, and On-time closure goals.
* Collaborate with Compliance colleagues in reviewing Quality System SOPs within the scope of the Quality Unit.
* Provide customer support via TLC and email, promptly responding to quality inquiries.
* Assist in drafting FMEAs.
* Manage drafting, archiving, and distribution of controlled company documentation.
* Within PDS, perform document issuing activities to support Production, PPT, and Quality System colleagues.
* Draft and review QATs with customers and site QPs.
* Participate in PPI initiatives (Kaizen and Gemba) supporting continuous site improvement.
* Support team and other functions to ensure readiness and support for BUs processes.
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