- BioAgilytix (Durham, NC)
- …right at home here at BioAgilytix.Essential ResponsibilitiesPerform Quality Control ( QC ) technical, scientific, and compliance review of data and ... will be a critical part of our beginning-to-end client data quality processes. Through your technical reviews...GMP).Identify deviations, OOS and OOT associated with Bioanalytical Operations data as applicableIssue QC review … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a QC Data Reviewer as part of the Quality team based in Raritan, NJ. Role Overview The ... QC Data Reviewer is an...is an exempt level position responsible for reviewing all data produced by the Quality Control...interacting with inspectors. Due to the nature of the Data Review process, this role is 100%… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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...commercial operations in a controlled cGMP cleanroom environment. Create, review and approve relevant QC documents, logbooks,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …under the direction of the QC Manager. Relationships Reports to: Quality Control Manager Number of subordinates with direct/indirect referral: no direct ... and QC for the coordination of process/equipment improvements, sample testing and data trending/analysis Review of completed QC documentation Ability to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Ensures quality control activities are aligned with industry, regulatory and ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...microbiological assays, techniques and industry practices Participates in the review of microbiological trending data and writing… more
- Tris Pharma (Monmouth Junction, NJ)
- …results using instrument specific data processing software. Complete timely compendial review to maintain QC lab compliance, + work w/ rel departments ... QC Lab Operations Specialists for Tris Pharma, Inc....+ Dissolution Apparatus (Distek). Initiate + draft investigations. Create, review + revise SOPs. Assess equip. perf. Execute equip.… more
- Merck & Co. (Millsboro, DE)
- …reliable supply to customers and patients on time, every time, across the globe.The Quality Control ( QC ) Associate Specialist, with Guidance from the ... QC Manager, ensures product/process quality through the review of GMP documentation...requirementsSAP transactions, inventory control , GMP documentation and data integrityResponsible for the review and release… more
- Aequor (West Greenwich, RI)
- …GMP operations and Environmental/Water monitoring. 2. Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory ... responsible for activities including microbiology & analytical testing, sample and data management and equipment and instrumentation operation and maintenance in a… more
- BioAgilytix (Boston, MA)
- …to GxP guidelines)Essential Responsibilities: Data Review & DocumentationPerform Quality Control ( QC ) technical and scientific and compliance ... GLP, GMP) and non-regulatedIdentify deviations, OOS and OOT associated with Bioanalytical Operations data as applicableIssue QC review observations and work… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and maintain specifications as per CDISC SDTMIG.Perform SAS programming to provide complex data review listings and reports to support Data Management ... report forms and database structures.Develop reports & graphs in Spotfire for easier data review and visualization. This includes developing programs for patient… more
- Lundbeck (Bothell, WA)
- …use in GMP testing) Oversee routine analytical testing and coordinate study support across Quality Control ( QC ) and Process Development (PD) groups Oversee ... optimizing new potency assays and then supporting transfer to QC , including supporting QC (as needed) with...will interact with Lundbeck Seattle Upstream, Downstream, Formulation, and Quality Control groups so strong interpersonal skills… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to identify and drive initiatives to modify existing business processes to ensure quality data for use by downstream programs/users. Relationships This role ... and Master Data Management principals like reference data , match merge, cleanse lists, rejects QC ...to various team members Collaborate across boundaries to ensure data quality requirements are being identified across… 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …throughout various rounds of PMRP Communicate changes to project initiator/vendor Provide quality control signoff in PMVP Provide final PMRP approved PDF ... and immune disorders.SummaryThis position is responsible for the overall quality of materials subject to Product Material Review...(PMVP) submission to ensure metadata is accurate and submission data is complete for review Review… more
- Aequor (San Diego, CA)
- …will include, but are not limited to, the following: Semi-independently execute defined experiments, data analysis and data QC Report on scientific results ... productive relationships with other scientists May involve presentation of data to manager and project team Thoughtful review... data to manager and project team Thoughtful review of data and help plan next… more
- Merck & Co. (North Wales, PA)
- …confidentiality, consultant agreements and external engagement meetings.Participate in quality control and integrity of study data and reports for ... which may include (but is not limited to) the implementation of primary data collection, chart review /survey, database studies, health economic model development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Management, and Non-clinical Development. Essential Functions Authors, edits, and provides QC review of documents to support clinical trials and regulatory ... Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to… more
- Catalent (St. Petersburg, FL)
- …Order Parts List and recording all movement of Lot Controlled materials in the DSI/JDE. Review Work Order schedule and create hard copy Work Order Parts list in J. ... disposal and waste material for pickup by Outside Contractor. Locate materials for QC and stage for inspection. Perform physical inventory count (secondary du ty)… more
- Aequor (Thousand Oaks, CA)
- …QC prioritization in conjunction with site as needed Creates and maintains source master data in SAP and Rapid Response Review network-wide master data ... of demand and supply Effectively engage key partners within supply chain, quality , finance, process development and other functional areas as needed Provide ad… more
- Catalent (St. Petersburg, FL)
- …challenges.Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and ... Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. The… more
