- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, New Jersey. Role ... Overview The Lead QC Microbiology Data Reviewer is an exempt level position...critical inputs to site environmental monitoring program. Perform peer review /approval of laboratory data including endotoxin, sterility,… more
- BioAgilytix (Durham, NC)
- …you'll be right at home here at BioAgilytix.Essential ResponsibilitiesPerform Quality Control (QC) technical, scientific, and compliance review of data ... in this role and you will be a critical part of our beginning-to-end client data quality processes. Through your technical reviews of raw and processed data… more
- Catalent (Manassas, VA)
- …Safe Quality Foods (SQF) Certification, and its initiatives. This position also requires Quality Control data base management and control over ... and analytical services to solve difficult development and manufacturing challenges.The Quality Assurance Supervisor will lead Food Safety and Quality … more
- Catalent (San Diego, CA)
- Quality Control Chemist IPosition SummaryCatalent Pharma in San Diego, CA is hiring a Quality Control Chemist I. The QC Chemist I will be responsible for ... the common operations in a fast-paced, early Phase-focused, dynamic Quality Control group.This is a full-time position:...for investigations and deviations. Begin to develop skills to review data packets for technical and compliance… more
- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Quality Control Associate will serve as a strategic and tactical ... quality professional in ensuring oversight and execution of all...and accurate testing, reporting, and releaseThis role will assemble, review and trend release, IPC, and stability data… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …as labeling collection tubes and transporting supplies to appropriate area, quality control review of data , coordinating sample shipment, and acting as ... shift or study lead. Activities as lead may include scheduling team work assignments and acting as primary point of contact for the study director for a particular shift.QualificationsRequires a high school diploma or equivalent and 3-5 years of related… more
- Insmed Incorporated (San Diego, CA)
- …protocols, and reports as neededEnsure the timely execution of all routine QC testing, data review , and preparation of summary reportsMay act as an analytical ... CMC team.Perform quality management activities such as deviation, CAPA, change control , investigation of OOS, OOT and anomalous results within the company QMS… more
- Merck & Co. (Rahway, NJ)
- …stakeholder expectations; facilitation of cross-functional decisions.3. Defines trial-level requirements for quality data collection and validation at the trial ... to: 1. Develops detailed project plans for the collection, review , and cleaning of all clinical data ...protocol specific data validation elements).4. Manages trial-level data quality and completion of database lock… more
- Merck & Co. (Rahway, NJ)
- …but not limited to: eCRFs, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and In-life Reports, Encoding and Data ... to report output.Accept and execute special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other… more
- Catalent (Manassas, VA)
- …standards; Responsible for ensuring compliance with FDA and cGMP standards for Quality Control , including continuous training; Responsible for ensuring Dietary ... help create engaging new products consumers will love.The Document Control Specialist - 2nd Shift is responsible for creating...completed. Utilize the computer to enter and track result data ; Report any deviations to the Quality … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …specific BICR experience; regularly monitor reviewer metrics for quality control in support of clinical trial endpoint data , and collaborate with Imaging ... Collaboration: Collaborate with clinical team and/or statistical team to perform routine review of BICR data to ensure expectations are met with… more
- Aequor (New Brunswick, NJ)
- … management principles - Good Knowledge of evaluation and interpretation of stability data using statistics software. Review data and demonstrated ability ... controls. Review and endorse change controls as an expanded reviewer . Initiate change controls related to stability operations Provide the technical requirements… more
- Merck & Co. (Millsboro, DE)
- …and state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP standards, and emissions ... of the animal care staff, serving as a designated reviewer and voting member of the Institutional Animal Care...facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination… more
- Novo Nordisk Inc. (Durham, NC)
- …Join Team Novo Nordisk and help us make what matters. The Position Performs quality review & approval of Batch Production Records (BPRs), Change Requests (CR's), ... process confirmation on shop floor. Handles release of raw materials & provides quality oversight, review & approval of validation activities associated with… more
- Catalent (Harman, WV)
- …biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance/ Quality Control function with a strong familiarity ... raw materials release, and compiling, trending and reporting key quality metrics for Senior Management review , and...supervisionAbility to work in fast paced environment supporting the quality assurance/ quality control departments of… more
- Insmed Incorporated (Bridgewater, NJ)
- …years relevant experience requiredExtensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.Commercial drug ... of compliance requirements, work with critical suppliers to ensure quality , consistent supply. Review and monitor all lab...PM, etcReview and approve deviations, CAPAs, SOPs and Change Control related to QC Lab and operationsPartners within QA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all vendor managed business setups with the objective of achieving the highest data quality standards, full adherence to patient's rights and well-being and ... groups and respective CROs in order to ensure high data quality and proactive detection and resolution...the Quarterly Quality Report (QQR) and Clinical Quality Review Boards (cQRBs).Ensure continued submission and… more
- Catalent (Philadelphia, PA)
- …of worldwide Quality operating procedures as needed. Provides leadership for Data Integrity and Computer System Validation documentation review and approval ... This individual will have responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control , and Customer… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal ... compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by...develops approach to solutions Ability to work on complex Quality projects where analysis of data requires… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Quality Assurance Liaisons (SQAs)Provide leadership, and developmental opportunities Review relevant Investigations, Change Control , and CAPA(s)Work with ... and manufacturing areasSupport validation and qualification activities Perform Spot-Check Data Reviews Change Control ProcessInternal Process Observation… more
