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1 to 2 years experience working in a regulated CGMP manufacturing plant (preferably Pharma / Biotech / Life Sciences industries)Knowledge, Skills, AbilitiesKnowledge of inventory control techniques, proven understanding and application of planning functions related to Capacity Planning (CPS), Master Production Scheduling (MPS), Material Requirements Planning (MRP), and interfacing systems (, QA, Forecasting.
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Must be skilled in data reconciliation and using the reporting features of the BSI. Experienced in written and verbal communications with either commercial clients or government investigators and a strong documentation background in a laboratory setting with respect to regulatory requirements (cGMP, cGLP or ISO) and Standard Operating Procedures is a requirement.
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KeywordsProject manager, program manager, program management, pmp, project management professional, cmc, mst, msat, ms&t, manufacturing, pharmaceuticals, biotechnology, vaccine development, vaccine manufacturing, capital funding, capital funds, gmp, cgmp, good manufacturing practices, sow, statement of work, asset management, root cause analysis, depreciation management, asset disposal, critical path method, monte carlo analysis, lean principles.
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Demonstrated knowledge and application of FDA cGMP/GCP regulations, ANSI/ISO/IEC/ASQC standards, and 21 CFR Part 11 in a manufacturing setting. against cGMP and requirements for validation.
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You will also be a qualified trainer on-the-floor, follow and execute cGMP documentation, maintain qualifications in Production Technician duties, and utilize Manufacturing Execution Systems (MES.
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CGMP document review, which may include batch records and/or validation protocols. OFCCP Statement Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.
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Review of existing systems, document review, general consulting and auditing for programs needed to comply with regulatory requirements of FDA and other regulatory authorities worldwide. Candidate will aid in the design, preparation, implementation, and management of client quality systems.
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Assures compliance to cGMP parts 210 and 211 and company quality systems. Follows standard operating procedures (SOPs), facility safety guidelines, and Food & Drug Administration (FDA) requirements which may include compliance with cGMP CFR parts 210 and 211 where applicable.
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QA Manager duties are to include managing the QMS to make changes towards cGMP compliance with applicable sections of 21 CFR Regulations for medical devices and QA monitoring of manufacturing, quality, logistics and customer management processes.
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Establish process and documentation for EM monitoring program to support cGMP manufacturing (MFG) operations. Team members will support cGMP manufacturing in a dynamic new company setting.
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Possesses thorough knowledge of current domestic and international standards and regulations related to pharmaceutical dosage forms/devices, (e.g., cGMP, GLP, ICH guidelines and guidance documents) and how to apply them to products pending release, and marketed products.
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Project manager, program manager, program management, pmp, project management professional, cmc, mst, msat, ms&t, manufacturing, pharmaceuticals, biotechnology, vaccine development, vaccine manufacturing, capital funding, capital funds, gmp, cgmp, good manufacturing practices, sow, statement of work, asset management, root cause analysis, depreciation management, asset disposal, critical path method, monte carlo analysis, lean principles.
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The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.
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The position will report directly to the VP of Manufacturing and will work hand in hand with Quality, QC/AD, Clinical/ Regulatory, Materials, MSAT and PM to ensure high quality cGMP product is delivered on time and in full.
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The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
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cgmp job in Frederick, MD
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