Supervisor QA - ATS
MedImmune - Frederick, MD

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Responsible for staff supervision including scheduling, recruiting and performance management. Oversee team responsible for Quality oversight of manufacturing operations and execution and completion of the following: On the Floor reviews of SPR/MPRs, autoclave cycles, alarms, logbooks and temperature charts. MPR/SPR/logbook page issuance. Assist in product changeover and placing equipment on QA hold. Review and approve work orders, create master data in SAP, review master and instrument calibration records. Utilizes Quality Systems in compliance with current good manufacturing practice regulations and corporate policies and procedures. Use the Track Wise system for non-conformance, change control and OOS management. Ensures that root cause investigations are performed, recommends and/or supports implementation of corrective actions to prevent recurrence. Approves non-conformances, CAPAs, extensions and change control records. Compliance with SOP and regulatory requirements per the requirements of the self-inspection program. Assists the site inspection readiness program. Responsibilities may include: Auditing (internal and external) - utilizing risk based strategy. Aegis workflow review and approval. Write/revise SOPs and work instructions. Manage internal tracking database (SAP, lot status, observation logs) and create monthly metrics. Responsible for assuring the quality of products manufactured at the facility. Implements strategic initiatives and translate into tactical solutions; participates in planning strategic initiatives. Implements scalable solutions, including quality policies, manages quality systems, and facilitates regulatory inspections. Provides leadership and strategy development guidance to other functional areas in areas of regulatory compliance, quality practices and procedures and quality systems.
Work is performed with moderate direction. Completed work is reviewed, from a mid-term perspective, for desired results. Contributes to the completion of specific programs and projects. Able to interpret and apply company policies.


7- 10 yrs of QA experience. Prior night shift experience is desirable.

Bachelors in Sciences

MedImmune - 10 months ago - save job - block
About this company
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MedImmune works to boost the immune systems of babies and grown-ups. Its flagship biotech product, Synagis, prevents respiratory syncytial...