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The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
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DPS Group is seeking a qualified Senior Quality Assurance Operations professional to perform batch disposition, batch record review, deviation, CAPA and change control support at the Boston, MA client site.
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Must have strong knowledge of biologics and small molecules manufacturing, materials management, quality control, quality assurance and CMC regulatory requirements. The position is responsible for product development, technology transfer and overall management of CMC activities related to ensuring robust development and reliable GMP supply of oligonucleotide conjugates and intermediates.
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Support Associate Director in the management of PECOs Quality Assurance program in partnership with key stakeholders to support multiple customer-facing teams of varying tenure and experience.
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The Senior Analyst / Scientist will work cross-functionally with others in Quality Control, Analytical Development teams, Quality Assurance, and Manufacturing, as needed. The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs) and analytical assays for AAV efficacy (potency), safety and product quality.
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Collaborate with cross-functional teams, including the CDMO joint project team, Obsidian Process and Analytical Development, Quality Assurance, Quality Control, and Regulatory to assure effective tech transfers and start-up of new manufacturing processes according to agreed upon timelines in support of business objectives.
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Reporting to the Field Operations Manager, Quality Assurance Inspectors partner with HPC's, residential customers, and Abode office staff to ensure that work completed under the Mass Save program meets program standards, is high quality, and delivers a great customer experience.
$15,000 - $72,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Support regulatory inspections, supplier audits, and client auditsLead, facilitate and participate in Quality meetings, Raw Material Review Board, Supplier Review Board and Quality Management Review.
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Director GMP Quality Assurance will collaborate with the CMC department and external Vendors to ensure oversight and compliance. Reporting to the Sr. Director of GMP Quality Assurance.
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Ongoing supervision and education of Nutrition Assistant staff through review and co-signing charts for purposes of Quality Assurance required by Federal/State standards. WIC Program Nutritionist provides the full range of WIC nutrition services to applicants and participants (infants, children, prenatal and postpartum women, both breastfeeding and non-breastfeeding) under the supervision of the Senior Nutritionist.
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The Director/Sr. Director, Global GMP Quality has multiple direct reports, is a member of the Quality Assurance Leadership Team (QALT) and reports to the Vice President, Quality Assurance.
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Required Experience: Experience with economic sanctions related risks and a solid business understanding of financial services industry, especially those associated with correspondent banking, corporate banking, treasury management and capital markets conducting sanctions reviews.
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GMP quality assurance experience in the pharmaceutical or biotechnology industry. The Sr Specialist Quality Assurance will be responsible for quality review of production and testing of clinical trial materials at external manufacturing site.
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Knowledge of hotel operations, including marketing plans, security and safety programs, personnel and labor relations, preparation of business plans, repairs, maintenance, budget forecasting, quality assurance programs, hospitality law, and long-range planning.
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HRV Conformance Verification Associates, Inc. supplies a highly integrated series of professional engineering and quality assurance/quality control services worldwide that span the steel, concrete, paint, mechanical, and construction industries.
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quality assurance supplier management jobs Title: director in Waltham, MA
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