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GMP resumes in Indianapolis, IN

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Project Development

Indianapolis, IN
... 2012 Analytical Development Chemist on contract, Indianapolis, IN Infrared Spectrometry and HPLC analyses, repair and troubleshooting instruments Documentation for European REACh certification UCB Generic Pharmaceuticals, for c-GMP Quality Control ... - 2019 Feb 25

Engineer

Carmel, IN, 46032
... She also completed required training modules (FDA and client mandated) and internal staffing firm courses on topics such as GMP, commissioning, validation, writing, execution, automation, safety, and project management. Some of her project ... - 2018 Oct 27

Excellent communication skills, good negotiating skills

Indianapolis, IN
... Pharmacopeia and departmental Standard Operating Procedures utilizing UV/vis, IR, pH meter, particle counter, wet chemistry Worked under strict Good Manufacturing Practices (GMP) QUAD PHARMACEUTICALS, INCORPORATED, Indianapolis, Indiana 1986-1992 ... - 2018 Oct 22

Project Management Manager

Brownsburg, IN, 46112
... Managed and tracked remediation deliverables for Legacy Systems to meet GMP, Medical Device Computer Systems Validation, and CFR 21 Part 11 Requirements. Complete SDLC retrospective development and validation including Intended Use/Systems ... - 2018 May 28

Quality Manager

Indianapolis, IN
... My in-depth knowledge, experience and expertise are: ISO 9000, 9001:2008, ISO 14001OHSAS 18001, GMP, FDA work environment Quality processes and statistical techniques / SPC, Audit and inspection Root Cause Analysis, Manufacturing Investigation and ... - 2018 May 25

Quality Management

Indianapolis, IN
... Highly proficient in driving and ensuring all activities comply with ISO Standards, FDA regulations, current Good Manufacturing Practices (GMP’s), customer specifications, and all other applicable requirements. •Quality Management System •FDA, ISO & ... - 2018 May 12

Clinical Research Assistant

Indianapolis, IN
... viability assays: MTT, CCK8, SRB Microplate handling for high throughput screening for cell based assays Good working knowledge of ICH GCP principles and ICH compliant regulatory submissions - IND, NDA, BLA, GMP, ISO and FDA regulatory guidelines. ... - 2018 Apr 26

Quality Supply Chain

Indianapolis, IN
... Reduced finished goods micro destructions by 35% through root cause investigations which lead to improvement in GMP awareness, time and temperature monitoring, additional product testing and equipment breakdown during sanitation Significant ... - 2018 Mar 22

Operator Manufacturing

Indianapolis, IN
... Strong understanding of GMP regulatory requirements as they relate to laboratory practices and manufacturing processes. Strong knowledge to work through production issues including basic troubleshooting skills, and use of tools. Excellent ... - 2018 Mar 13

Quality Engineer / Analyst

Indianapolis, IN
... Indianapolis, IN Senior Quality Engineer July 2014 ~ present Currently serving as a people leader, and responsible for guiding a small team in quality management and complaint handling while demonstrating GMP and quality initiatives within the meter ... - 2018 Jan 22
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