- Astellas Pharma (Westborough, MA)
- …in **Westborough, MA.** **Purpose:** The Validation Specialist , Quality Assurance , will provide QA oversight of commissioning, qualification and ... **Senior Validation Specialist , Quality Assurance ** Do...to, the following:** + Individual Contributor responsible to execute QA Validation Strategy for clinical and pre-commercial… more
- Amgen (New Albany, OH)
- …your best work alongside other innovative, driven professionals in this meaningful role. ** Quality Assurance Specialist ** **Live** **What you will do** Let's ... Reports, Electronic Master Batch Records etc. + Provides quality oversight for quality records...industry + Affinity with digital innovation, data sciences and Quality engineering + IS validation knowledge +… more
- Bristol Myers Squibb (Devens, MA)
- …. Position Summary The Shop Floor Quality organization has responsibility for quality oversight and responsibility for advising and assuring quality ... Manufacturing Practices (cGMPs). In the capacity of Shop Floor QA , the Senior Specialist shall serve as...and track process performance related to key Shop Floor quality assurance quality tasks and… more
- Novo Nordisk (West Lebanon, NH)
- …EMEA or a leading international regulatory agency preferred + As applicable, experience with Quality Assurance oversight and support for all phases of ... Will be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions + Reviews all manufacturing and support records… more
- Novo Nordisk (Clayton, NC)
- … QA presence & process confirmation on shop floor & improvement of Quality processes. Relationships Manager, Quality Assurance . Essential Functions + ... & requirements from health authorities are reflected in the validation planning & quality related decisions +...to root-cause analysis + Participate in process confirmations & quality oversight + Authorized person according to… more
- Cambridge Isotope Laboratories, Inc. (Xenia, OH)
- Cambridge Isotope Separations (CIS) has an outstanding opportunity for an experienced Quality Assurance Senior Specialist based onsite in our Xenia, OH ... its CIS facility. Summary: Primary responsibility of the GMP Quality Assurance Senior Specialist is...Responsibilities: Responsibilities include, but are not limited to: + Oversight and maintenance of various Quality Systems… more
- Catalent Pharma Solutions (Madison, WI)
- ** Specialist II, Quality Assurance ** **Summary:** _Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing ... heart, and lung diseases as well as Alzheimer's._ The Quality Assurance department is responsible for all...material testing and disposition, and training, as well as oversight of the equipment calibration and preventive maintenance program… more
- Hovione (East Windsor, NJ)
- …sexual orientation or ethnicity. (https://en-careers-hovione.icims.com/jobs/10300/senior- quality - assurance - specialist ... oversight of activities, as required. - To approve Validation Master Plans, Process Validation Protocols and...have the potential to mitigate unnecessary complexity - Master Quality Assurance processes and tools - Manage… more
- Catalent Pharma Solutions (Madison, WI)
- …network, Catalent Biologics is positioned to drive significant growth for Catalent. The Quality Assurance department is responsible for all aspects of the ... ** Specialist III, Quality & Compliance** **Summary**...quality assurance functions at Catalent, Madison. The...drug products for our clients and their patients. The Quality & Compliance group has oversight of… more
- Pfizer (Rochester, MI)
- …Will Achieve** You will be a member of Pfizer's dedicated and highly effective quality assurance team. You will evaluate and review Pfizer's clinical and ... Good Manufacturing Practices {also cGMP} impacts. + Investigate, document Quality Assurance related deviations and escalate issues...Good Manufacturing Practices {part of GxP} practices. + Provide Quality Review and oversight of site cGXP… more
- System One (Warren, NJ)
- …safeguard and maintain the safety and quality of company's products. + Provides QA oversight on key software development life cycle (SDLC) processes such as ... Contract Overview Leading Pharmaceutical company looking for an experienced QA Specialist . Ideal candidates should have a...and compliance. + Previous experience as a computer system validation / quality assurance for… more
- Lilly (Branchburg, NJ)
- …operations. This position will interact with the manufacturing, engineering, validation , quality control and regulatory departments. Interaction may ... with other Lilly site / contract producers of Lilly products. The Quality Professional works within Lilly cross-functional groups, anticipates and resolves problems… more
- Gilead Sciences, Inc. (La Verne, CA)
- …We are seeking a highly motivated individual to join us as a Sr. QA Specialist for the Gilead La Verne Quality Assurance Department. This role involves ... Change Management records as required + Participate in the QA oversight of stability program and lifecycle...and USP <1220> + Experience across broad areas of Quality Assurance and/or Quality Control… more
- Contract Pharmacal Corp (Hauppauge, NY)
- …Hauppauge, NY (http://maps.google.com/maps?q=135+Adams+Avenue+Hauppauge+NY+USA+11788) Apply Description Position Summary: The Specialist of Quality Assurance ... Compliance (Computer Systems) is responsible for providing system administration oversight for 21 CFR Part 11 Computer Validation Systems (CVS). This includes… more
- Catalent Pharma Solutions (Harmans, MD)
- …Support regulatory (FDA, EMA) and client audits/inspections of Catalent. * Provide quality oversight of process and analytical method development in an ... **Senior Specialist , QA Analytical** **Position Summary** Catalent...R&D setting for client projects; provide quality oversight in compliance with… more
- Lilly (Durham, NC)
- … Quality System from the ground up. The Quality Assurance Floor Support Specialist works as a member of the QA Floor Support team and reports to the ... is completed and remains in compliance. + Communicates with Quality Specialist Lead and QA ... Specialist is responsible for providing support and QA oversight to GMP operations in the… more
- Insight Global (Philadelphia, PA)
- …degree in engineering or Life Sciences 5+ years of total combined experience in quality assurance and/or validation within a GMP regulated manufacturing ... and startup activities for large capital projects as a Quality Assurance resource. Review and approve system...environment (FDA, EMA, MHRA experience providing QA oversight of qualification of equipment, utilities,… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …years' of pharmaceutical experience required with prior experience in analytical method validation and quality assurance experience. Strong understanding of ... Job Title Analytical Method Validation Specialist Requisition JR000014442 Analytical Method...intended use. This role is critical in maintaining product quality and minimizing risk associated with analytical processes. The… more
- Bank of America (Chandler, AZ)
- …issues and control improvements for remediation + Implements optimized controls and enhanced Quality Assurance ( QA ) practices to support business continuity ... Job expectations include monitoring and testing controls and implementing quality assurance and quality control...by the BSA. Position Summary The Senior Business Control Specialist will provide oversight and support in… more
- L3Harris (Herndon, VA)
- …of 8 years of prior Quality Engineering experience. + Experience in Quality Assurance within the aerospace, defense, FAA or similar industry. + Familiarity ... Job Title: Specialist , Quality Engineer Job Code: 13242...applicable Work Breakdown Structures (WBS) for Software and Hardware Quality Assurance . + Develop and implement audit… more