- Aequor (Newbury Park, CA)
- …a plus, but not required. Knowledge of industry-wide regulatory systemsDuties: Act as Quality Assurance ( QA ) contact for Change Control(s) for Computerized ... of management Ability to lead and influence staff outside QA organization Able to manage performance issues and conflict...years of direct experience in lieu of education requirements Org Unit: GxP Computer Systems Quality Assurance … more
- Aequor (West Greenwich, RI)
- …for this role? IE office based, lab based, manufacturing floor? This is plant quality assurance role, therefore the EW will spend 50-60% of their time ... in a QA role on the manufacturing floor and the remaining...this vital role, will be responsible for PQA (Plant Quality Assurance ) On the Floor in support… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …by the FDA, EMEA or a leading international regulatory agency preferred Experience with Quality Assurance oversight and support for all phases of Clinical and ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch… more
- Aequor (West Greenwich, RI)
- …equivalent combination of education and/or experience. Typically 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or ... in candidates to work best with your team? Experienced QA - self driven When reviewing resumes, what stands out...Someone who has worked in biotech for years in QA - on the floor experience would be great What… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and focus on the delivery and execution of non-project initiatives within R&D Quality and Global RD/PV QA by collaborating with business process owners ... on applicable Global QA processes and quality standards for continuous improvement and operations excellence. This may include the review of business partner… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …must have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Supervisor as part of the Quality... QA Investigations Supervisor as part of the Quality team based in Raritan, NJ. Role OverviewThe … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …provides direct support for all finishing manufacturing activities. This position supports the Quality Systems within the Quality Assurance Unit ensuring ... Good Manufacturing Practice (cGMP) for in process manufacturing pharmaceuticals. Provides Quality Assurance support for all manufacturing activities performed… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... in the treatment of multiple myeloma.Legend Biotech is seeking QA , Document Control Specialist (1st Shift) as part of...Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Specialist (1st shift) role is an… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …SQE Manager, QA Compliance, is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ensuring ... with all CFR, USP, cGMPs, and SOPs. SQE Manager, QA Compliance will rely on experience and judgment to...to plan and accomplish goals specific to the Supplier Quality Program. This position supports the ongoing development and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position is ... ultimately responsible for the product quality received by the customer and the quality system integrity expected by the customer. The Quality Director is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Executive Administrative Assistant to provide comprehensive support to leaders and members of GMP Quality Assurance team and will serve as the primary point of ... for someone with pharmaceutical industry experience supporting senior leaders within Quality or related function.Proficiency in Microsoft Office Suite (Word, Excel,… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Specialist, Quality Assurance 2nd Shift - Our Company constructed a new manufacturing facility to significantly expand its ... lyophilization, product inspection, and quality control laboratories. - The Quality Assurance Specialist will support this expansion. Project activities… more
- Tris Pharma (Monmouth Junction, NJ)
- …Summary:The Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance ( QA ) Investigations and Product Quality ... Improvements (CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and resolve basic to moderate operating difficultiesCollect required samples needed for Quality Assurance testing as requiredPerform line changeovers in a safe ... of the production lineComplete all required documentation and scheduled quality checksEnsure adequate supply, function, and output of production equipmentAdjust… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance , Finance, R&D, Project Management and Quality ... coach cross functional team staff in areas such as quality , compliance, safety, project planning, process development, technology development.Communicate effectively… more
- Merck & Co. (Durham, NC)
- …Complaints, Corrective Action/Preventive Action Management, Annual Product Review Authoring, and Quality Council.The Senior Specialist, Quality Assurance ... Job DescriptionJob Description:Senior Specialist, Quality AssuranceThe Senior Specialist, Quality serves as a member of a team responsible for instituting… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …daily record keeping for animals and room environments in accordance with LBRI quality assurance standards and regulations. Will maintain cleanliness of the cage ... wash area, warehouse, diet kitchen and any animal equipment storage areas. Outstanding Communication skills and the ability to work harmoniously with team members and all professionals is a must. This is an entry level position that does not require previous… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing complianceKnowledge of cGMP regulations and ... outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any required… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Bachelor's degree or equivalent experience required 8+ years of operations, quality assurance , call center, compliance, project management, operations and/or ... lead who is responsible for ensuring that all aspects of our patient quality and safety operations meets standards. This position requires a highly motivated… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance.Expertise in GMP compliance ... knowledge including knowledge of 21 CFR Part 11, EU Annex 11 among othersExperience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.Thorough knowledge and understanding of GMP data integrity standardsKnowledge of cGMP… more
