Kristen Moshier
Sr Qa Audit Specialist @CAMRIS
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WORK HISTORY
Sr Qa Audit Specialist @CAMRIS
Silver Spring, MD, US
Support QMS and contract manufacturing at Pilot Bioproduction Facility (PBF) at Walter Reed Army Institute of Research (WRAIR), Phase I-II vaccines.• Review/approval of GMP Master and Executed Batch Records• QA On the Floor (OTF) activities – line clearance, room release, label review, disposition (DS/DP)• Lead QA team in design and implementation of Internal Audit program for site• Improvements to disposition process, specifically updating site procedures to allow for rejection/conditional release and developing/updating forms to support disposition activities• Act as SME for training program improvements• Data review for Environmental Monitoring (EM), release specifications, stability data• Work closely with QC and Manufacturing groups to close outstanding projects• Lead QA effort for GDP/Data Integrity improvements, including acting as mentor/SME for other departments• QA point of contact for contract manufacturing customers
EDUCATION
Stony Brook University
B.S., Chemistry
SKILLS
ABOUT KRISTEN MOSHIER
Conscientious, resourceful individual with both proven experience with a leading pharmaceutical company in Technical Writing and Compendia Compliance and in a private setting in Data Management/Clinical Trial work. Well organized, strong attention to detail and ability to prioritize and multi-task. Inquisitive and adaptable. Works well both individually and with others to achieve goals. Experience in: MS Office (Word, Excel, Powerpoint, Outlook), Quality Center, ICH/GCP guidelines, Medidata RAVE, Labware LIMS, Wisdom, Trackwise and Oracle, USP, FDA, IRB
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