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Online Resumes with "OOS investigations"
QA Manager, Boca raton, FL
To obtain a position where my education and experience and previous work history would help the firm. I am knowledgeable and have worked with 21 CFR 11, 210 and 211.I was responsible for all 3rd party audits; was the responsible head for all FDA audits and responses; headed the CAPA and OOS Investigations and was involved with International Regulatory submissions as well as all FDA submissions. I was resopnsible for all OO...
Tags for this Online Resume: Quality Assurance, Quality Control, Manufacturing, Teaching, Bio-Statistics, Regulatory
Chemist or research scientist - 9 Years of Experience
Sr.Research Chemist, Research Chemist, or Research Associate
Ideal Companies: Gilead, genentech, PPD, Bayside solutions, impax, illumina, Sancus, Covance, Grifols, Nurix, Coherus, Exelixis, intarcia, Biomarin, Roche, Forest laboratories, Ultragenyx pharmaceuticals, Publicis Touchpoint Solution, Baxter, Astrazeneca, pfizer, Abbott Laboratories, Baxalta, Amgen, Abbvie, Bayer, Relypsa, VWR, Bohringer Ingelheim, Medivation, Zymergen, Teknova, Sanofi, Johnson & Johnson, Celegene, Thermo Fisher Scientific, Fiveprime Therapentics, EMD, Amaris, etouch, Tricida, Glaxosmithkline, Zspharm, Biocentury, Teva, Alelon Services CORP., Mckesson, Valesta, Nektar, Dynavax Technologies, NEVRO CORP., OncoMed pharmaceuticals, Inc., Planet Pharm, Zogenix Inc., SRG Woolf Group, Deloitte
Tags for this Online Resume: UPLC, HPLC, GC, LIMS, Empower, LC-MS, Nasal Spray, dry powder inhale, Chemstation, FT-IR
Biochemist - 18 Years of Experience - Near 21224
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
Director of Quality - 24 Years of Experience - Near 11801
Professional Summary Highly effective professional offering 30 years of US global quality leadership experience developing strategies, improvement action plan and solutions. Dedicated leader to bring organizations together, focusing on hi performance culture leading to improvement and efficiency. Built fully engaged team that is motivated to achieve metrics and deliver ROI. Lead and empowered cross functional teams to impro...
Ideal Companies: end of the year 449.00 + 4 months of our service. resume rewtire and cover letter.
Tags for this Online Resume: TQM (Total Quality Management), Manufacturing, Assessments, Audit, Quality, Quality Management System, HACCP, Continuous Improvement, PCQI, Supplier site and internal audits, USDA, FDA, ISO 9001, SQF, BRC, ISO 22000, ERP, OOS, Investigation, CAPA, NCR
QA Professional - Former FDA CDER 15 years experience, ASQ CQE, CQA, CQMgr-OE, Microbiologist,- DC
Former FDA CDER Compliance Officer with 15 years experience in Pharma QA seeks Leadership position in QA Regulatory Compliance, Investigations, Audits
Ideal Companies: Solvay, Sciele, Monsanto, ConAgra, Bayer, CR Bard, etc. Novartis, Shionogi, CIBA Vision, Alcon, Allergan, Coca Cola, Johnson and Johnson, Pfizer
Tags for this Online Resume: TrackWise, Investigations, CAPAs, APRs, Minitab, SPC, SAS-JMP/Discovery, SAP, QA, Compliance, Medical Device, Pharmaceuticals, Biotechnology