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The Scientist is responsible for instrument validation/repair/maintenance from user side, reagents management, performing cell based assay and impurity assays according to and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs.
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Technical expertise includes Column Chromatography, tangential flow filtration, cGMP compliance, SOP development, operational/workflow efficiency, process validation and technology transfers. Support technology transfer and/or process development through active participation in ensuring that new processes fit and execute consistently in the cGMP space.
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Technically proficient in the following standard chemical procedures and physical measurements (wet chemistry): GC, GCMS, FTIR, HPLC,NMR, pH, acid value, peroxide value, oil content, water content, specific gravity, refractive index, Tg, optical rotation, salt content, solid content, color, ester value and other standard tests.
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Perform daily/weekly cleaning of infusion room and equipment as required per PMG's Standard Operating Procedures (SOPs). Standard Office Equipment (Phone, Fax, Copy Machine, Scanner, Email/Voice Mail.
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Assist in development, review, and approval of cGMP documents including, but not limited to: Master Validation Plans, FAT/SAT documents, Turnover Packages, SOP’s, specifications, traceability matrices, thermal mapping documents, and design documentation.
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Under the supervision of the Quality Manager / Quality Supervisor the QC Inspector ensures compliance with cGMP and company policies, procedures, and specifications. Minimum 1 - 3 years’ experience in Quality Control environment preferably in cosmetics, personal care, pharma, or food packaging industry with exposure to FDA and cGMP regulations.
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Come work for us and see how BrightStar Care employees uphold A Higher Standard. At BrightStar Care, we provide uplifting in-home care for seniors and older adults who require a helping hand, a supportive companion, and assistance with day-to-day tasks in their homes.
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Perform assigned activities in accordance with Otsuka Standard Operating Procedures, and regulatory requirements. Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance.
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Demonstrated ability to provide copy editing and proofreading to the highest standard under tight deadlines. The Copy Editor/Proofreader will also provide organizational support to the editorial team in the Office of Communications.
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Planning and overseeing cGMP pilot batches, including protocol, batch record, and report reviews. PhD in Pharmaceutical Science or a related scientific field with at least 7 years of experience in pharmaceutical formulation and product development.
$125,000 - $145,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Capture architecture and design information and decisions using-standard tools (Lean IX, Draw-IO, AMT, Confluence, MS Teams) 7+ years of experience supporting Pharmaceutical content management solutions and integration (Authoring, Submissions, Archival, TMF, Quality, DAM, PLM.
$60 - $70 an hourExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Own documentation for area of responsibility, including Standard Operating Procedures (SOPs), Work Instructions (WIs), protocols, data quality catalogs, and other policy and procedure documents.
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5 Must be able to comply with cGMP requirements – hairnet, beard guard, no jewelry except for plain bands with no stones. 7 Polyethylene, polystyrene, PET, polypropylene, polyurethane and purging compound materials are both processed and ground, which provides some fumes and dust.
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Oversee preparation of food, making sure that food items are prepared according to standard recipes and are presented to standards established by the PGA TOUR Golf Course Properties, Inc. to ensure member/guest satisfaction.
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Write C/Q/V documents following established standards and templates, including but not limited to the following: Commissioning Forms C/Q/V Protocols and Summary Reports Standard Operating Procedures Impact Assessments Specifications (URS/FRS/DDS) FATS/SATs.
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