- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document Control (QADC) ... Supervisor . The QADC Supervisor will supervise the...Defined career path and annual performance review and feedback process Diverse, inclusive culture 152 hours of PTO +… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Shop Floor Supervisor as part of the Quality team based in Raritan, NJ. Role Overview The ... QA Shop Floor Supervisor is an exempt level position with responsibilities for...Strong interpersonal and written/oral communication skills. Ability to quickly process complex information and often make critical decisions with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …assigned Support and participate in site shutdown activities Support Event Response Process Performs all job duties and responsibilities in a compliant and ethical ... card access and contractor management PO and invoice approvals within Supervisor approval authorization limit and within established time expectations Smartsolve… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Oversee, schedule and lead day-to-day QC Microbiology activities for routine in- process and product testing ensuring compliance, accuracy and timeliness of testing ... card access and contractor management PO and invoice approvals within Supervisor approval authorization limit and within established time expectations Performs all… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Operations Supervisor (2nd shift) as part of the Technical Operations team based in Raritan, ... NJ. Role Overview The Operations Supervisor is an exempt level position working within Technical Operations team, responsible for directing the daily production of a… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The QC Microbiology Supervisor leads, and monitoring the daily operations, activities, and workflow for the laboratory personnel. Additionally, you will implement ... testing standards, policies and ensure safety measures are followed. The supervisor will assist laboratory personnel with career development, performance and other… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Investigations Supervisor (2nd shift) as part of the Quality team based in Raritan, NJ. ... Role Overview The QA Investigations Supervisor has the responsibilities for providing quality oversight over...least 3 reports. Knowledge of Nonconformance and CAPA management process . Knowledge of cGMP regulations and FDA/EU guidance related… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …in- process activities and product development when instructed by supervisor Incorporate pre-planned process improvements/cost reduction program into ... manufacturing Perform area equipment and process validations in accordance with validation procedures Perform in-...Support manufacturing activities in other departments as instructed by supervisor Performs all job duties and responsibilities in a… more
- Catalent (St. Petersburg, FL)
- …for managing and documenting events / discrepancies associated with either product or process as well as managing / writing any investigations that may be a ... and Standard Operating Procedures through the periodic inspections and monitoring of process controls in all applicable areas of the manufacturing operation. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and meetings with CRO and Investigator Meetings.Support Fair Market Value process in evaluating study budgetsCollect information and coordinate with DS Regulatory ... deviation reports and elevate issues to the attention of the supervisor .Compile and maintain a monitoring review spreadsheet.Compile and maintain CRO Oversight… more
- Catalent (Manassas, VA)
- …ensure they are meeting quality standards; Report any deviations to QA Supervisor in complete appropriate details; Report any housekeeping issues that need ... perform job responsibilities; Resolve any problem related to the production process under their capabilitiesl Collaborate with production employees and management to… more
- Merck & Co. (Durham, NC)
- …and Skills:Demonstrated ability to lead a team (ie experience leading directly as a supervisor /coach or indirectly as part of a project or through routine process ... with pharmaceutical regulatory requirements Experience with facility, equipment and/or process start up activities in a sterile cGMP environment Demonstrated… more
- Merck & Co. (Durham, NC)
- …person is primarily responsible for supporting qualification of Fermentation Process Automation at our Company's Durham, NC facility. Responsibilities include:- ... associated with automation related deviations/investigations Communicates periodically with immediate supervisor about status of area of responsibility.Support digital innovation… more
- Merck & Co. (Durham, NC)
- …Fermentation, and Purification unit operations and associated clean utilities and process equipment.- The Associate Director will manage tactical and strategic ... process , equipment, and qualification activities while ensuring product quality and optimized maintenance processes, regulatory compliance, employee and environmental… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …IB and safety communications, DSUR, IND.Lead the CRO and vendor selection process in collaboration with the study team and outsourcing procurement management.Lead ... with the CRO and the study team. Oversee the site qualification process .Monitor clinical trial performance and quality metrics and share with study team,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …projects and other related support activities for the manufacturing facility and process . This individual works with supervision on routine tasks and detailed ... for this position. Relationships & Schedule Reports to: QC Supervisor (Microbiology) Schedule: Sunday-Thursday (8AM-5PM) Essential Functions Independently performs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for reviewing all data produced by the Quality Control Lab during In- Process and release Drug Product QC Testing, related to the manufacturing of cell ... the safety policies, quality systems and cGMP requirements. Immediately alerts supervisor /manager when data discrepancies are identified. Job duties performed may… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oversee the timely execution of the development, review and approval process incorporating input/recommendations from other reviewers (eg, Peer Reviewers, Legal ... Affairs reviewer, Supervisor ) and discussing with other functions as needed- Ensure detailed peer review of medical information documents and provide appropriate and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …requirements in a sterile GMP environment. This role will serve as the business process owner for the Corrective and Preventive Actions (CAPA) process , and is ... get resources and information from established internal contacts, and consult with supervisor for decisions outside established processes Requirements A minimum of a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in these applications Review of regulatory strategy documents; eg, provides supervisor with input on regulatory strategy documents Supervise, review and approval ... compilation and filing of INDs/NDAs/Amendments/Supplements We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At… more
