|Reference # : ||17-00708
||Title : ||QA Specialist - US|
|Experience Level : ||
||Start Date / End Date : ||10/03/2017 / 10/02/2018
| Description |
|The QA Operations contingent provides a link between operations and the various quality systems. Primary responsibility is to directly support Formulation, Filling and Lyophilization (FFL) Operations through real-time, on-line batch record QA review and approval and shop floor presence.|
? Perform technical review of cGMP documentation for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.
? Provide advice and counsel on cGMP and related quality assurance issues to the value stream
? Demonstrate sound decision making relating to quality issues
? Provide on the floor QA support and perform QA Operations activities (batch record issuance and review, room release, event assessment, documentation review, etc)
? Take initiative to follow-up on any issues concerned with quality documentation (e.g., investigations, deviations, and other required documentation).
? Perform review and support regarding discrepancies and/or anomalies noted during QA review of associated processes. This includes deviation investigations, customer complaint investigations, et al.
? Alert management of production trends which may serve as forewarning of process or equipment problems.
? Provide guidance and oversight for aseptic technique and behaviors for production activities in aseptic areas, complete gown qualification to enter aseptic areas
? BS/BA in biology, chemical engineering, life sciences. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
? QA and/or GMP experience.
? Working knowledge of pharmaceutical facilities, equipment and systems preferred. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
? Experience working in Aseptic processing environment/Knowledge of Aseptic behaviors preferred.
? Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance. Working knowledge of validation principles, quality systems (Deviations, CAPAs, Change controls) and FDA regulations
IMPORTANT: This is a first shift position (7-3:30) BUT the hours will differ during the training period. Per the manager, the new hire will be on first shift for the first 2 weeks, then manager will have them on an off shift for 2-4 weeks for training (length of time depends on how quickly they're picking things up and how quickly we can get through the training ? Manager would anticipate 2 weeks on 2nd and 2 weeks on 3rd ? reasoning is to get exposure to full process and all team members, and divide up training responsibility). Once training is completed, they will be on first shift primarily ? however manager will require flexibility and anticipate that 25% of the time, they will be asked to cover an off shift shift for vacations, trainings, etc. ALSO - The schedule will most likely change in 2018 but the manager is unsure about the exact sch at this time. Manager will discuss with candidates during the interview process.