Quality & Regulatory Jobs in Pharma & Biotech

The Rahway based Senior Specialist, Global Development Quality Operations - API , is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release, and maintenance in support of our company's clinical supply programs. This person will also independently review and approve documentation accompanying the disposition of API materials (including new modalities such as ADCs) to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory inspections. Independently performs audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure the compliance with Standard...

Working in the Finished Goods Platform, TPQM (Third Party Quality Management) within our Research & Development Division, the position will be responsible for serving as the key representative for the quality oversight of Clinical Finished Goods Contractors. The role will also lead GMP/GDP activities supporting the production of clinical supplies, on behalf of our Company. Key responsibilities include Managing the quality oversight of Third-Party Vendors for Clinical Finished Goods (FG). This dynamic position would also play a role in the review and certification of batches intended for use in clinical trials. Play a role in supporting Health Authority Inspections, participating...

Responsibilities The Quality Control Technician position is available at our Animal Health facility in Elkhorn, Nebraska, located on the West end of Omaha. Under general supervision, this position assists professional laboratory personnel by performing routine test media preparation, test sample distribution, laboratory equipment cleaning/sterilization, instrument calibrations, laboratory notebook maintenance and other duties as assigned by QC Manager. Reviews internal documents against regulatory requirements for accuracy and compliance. The equipment used includes but is not limited to microscopes, centrifuges, dry ovens, pipettes, pipette aids, syringes, laminar flow hoods, balances, autoclaves, freezers, coolers, liquid nitrogen, etc. Education Minimum Requirement...

Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The main function of the Specialist, QC Deviation Management is to initiate/author laboratory deviations (Incidents and investigations) in response to Quality Control events. Additional Responsibilities General Interacts with other areas including Quality Assurance,...

The West Point Quality organization ensures our products are manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our West Point campus, internal manufacturing facilities, external contract manufacturers and suppliers we create a global manufacturing network dedicated to deliver a compliant, reliable supply to customers and Patients on time, every time, across the globe. The West Point Quality organization is a team of leaders who will exemplify and cultivate our Company's core leadership behaviors and ways of working, fostering a culture of collaboration, innovation, and accountability across...

The Logistics, Compliance and Engineering (LCE) Co-Op will be a part of a cross functional team that concentrates on deviation management, change control, cold chain management, technology support, and operational efficiency projects in support of the North America Supply Chain Management (NASCM) organization. The LCE Co-Op will collaborate with Operations, Quality, Automation, and Validation to drive change in a collaborative manner. The candidate will gain some understanding of cGMPs and cGDPs and will be tasked with a problem(s) to solve while contributing to multiple projects and activities across the facility and North America transportation network as required. The individual must...

Our Quality Organization ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Under the direction of the Associate Director of Quality Control Laboratories, the QC Lab Manager is responsible for providing guidance and supervision to QC Specialists and Technicians to complete testing and testing support...

Are you passionate about serving patients with quality products? Within our Research and Development Division, the Global Clinical Supply (GCS) organization is accountable for the end-to-end supply chain (planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites and patients) across the product portfolio to enable the execution of Phase I-IV clinical trials in 60+ countries in accordance with worldwide GxP regulations as set by the US cFR, EU eudralex, and all applicable jurisdictions as well as Sarbanes-Oxley (SOX) financial, and Environmental Health & Safety agency guidelines. GCS operates in close collaboration with Discovery Sciences Clinical Supply (DSCS),...