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Sellersville, PA, 18960
... EDI Testing Web Testing Performance Volume testing Data Mining Sarbanes-Oxley Act (SOX), Clinical Practice/CFR Part 11 FDA regulatory (Drug management) TECHNICAL SKILLS: Operating Systems: MVS, Windows NT/2000 4.0/XP, UNIX, AS/400 RDBMS: Oracle ...
- 2018 Feb 01
Bethlehem, PA
... TRAINING: Computers, T.Q.M, S.P.C, T.P.M, Six Sigma, Team Building, Self-directed Work teams, M.R.P, E.R.P & SAP, OSHA & GMP regulations, USDA, FDA, HACCP, CIP, NSF, SQF Practitioner, Safety Committees and Pepsi CQV process. SALARY: Open.
- 2018 Jan 12
Lansdale, PA
... •Ensures compliance with current bioanalytical guidance documents (FDA, EMA, Health Canada, Crystal City White Papers, WRIB White Papers, GLP, EH&S, etc.). •Work to improve the efficiency, productivity, and profitability of the Bioanalytical ...
- 2018 Jan 10
Lansdale, PA
... - Participated in development of SOPs - Performed laboratory testing of cell growth and viral infection as per FDA requirements - Performed Environmental monitoring of production areas in compliance with cGMPs and CFRs - Maintained compliance at all ...
- 2017 Nov 25
Easton, PA, 18042
... Member of the site Quality Leadership Team (QLT) Additional Responsibilities and Laboratory Experience Trained on all applicable ISO 9001, FDA, and current Good Manufacturing Practices (cGMPs) as they pertain to the industrial gases industry Proven ...
- 2017 Oct 07
Malvern, PA, 19355
... Guidance Document and job aides • CAPA -evaluated for retrospective deletion of cases already submitted to Health authorities • FDA audit request - investigated cases with late submissions Global Medical Safety - Janssen 05/2012 – 06/2014 Senior ...
- 2017 Sep 29
Horsham, PA
... Reviewing and reporting deviation and violations Processing and QC ICSR from clinical trials and post marketed (Phase I to IV) Preparing and reviewing the data listings Reconciliation between safety and clinical databases Broad knowledge of FDA, GCP ...
- 2017 Sep 29
Horsham, PA
... Experience includes strong understanding of FDA’s Good Documentation and Quality Assurance Practices, GxP and 21 CFR Part 11 requirements for validated systems. Strong analytical and problem-solving skills. Developed a reputation of being a ...
- 2017 Sep 13
Collegeville, PA, 19426
... Operate and conform to FDA standards using approved SOPs and GMP. Capital Health Systems, Pottstown Memorial Hospital, Pottstown, PA Staff Pharmacist 2006–2016 Utilize Cerner PharmNet and PowerChart in receiving and processing physician orders. ...
- 2017 Aug 23
Conshohocken, PA, 19428
... Reviewed federal laws and regulations, including HIPAA, the American Recovery and Reinvestment Act of 2009 (HITECH) and various FDA regulations to determine possible effect to company policies. Evaluated automated testing tools such as Selenium, ...
- 2017 Aug 12