- Eisai, Inc (Raleigh, NC)
- …skills to foster effective collaboration across teams.ResponsibilitiesExecute core processes within Quality area: Review manufacturing batch records for ... accordance with internal standards.Support approval and issuance of Master Batch Records (MBRs)Assist with entering events, change...quality assurance functions in a GMP setting (eg, batch record review, SOP writing, auditing, … more
- Merck & Co. (Rahway, NJ)
- …development, and seamless technology transfer to commercial sites.The SSO Operations Specialist will provide hands on assistance for daily production activities ... This position is also responsible for ensuring facility readiness for batch processing and shares accountability for the building performance. Ultimately, this… more
- Aequor (Hicksville, OH)
- …component number. Reviews batch paperwork for accuracy and issues to the batch records clerk. Checks and prepares paperwork for upcoming batches. Sets up ... Packager - Support Specialist 2nd shift Packaging = /hr pay rate...and handling the material/equipment according to product specifications, reviewing batch paperwork, performing line clearances, setting up and monitoring… more
- Aequor (Thousand Oaks, CA)
- …to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses. Identifying improvement opportunities within the ... work alongside other innovative, driven professionals in this meaningful role. Role: Specialist Manufacturing, New Product Introduction Let's do this! At we strive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cleaning of equipment, and cryopreservation) according to standard operating procedures and batch records , while recording production data and information in a ... in the treatment of multiple myeloma.Legend Biotech is seeking Operations Support Specialist , Sun-Wed 2nd Shift as part of the Technical Operations team based… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Specialist , is a member of the Site Automation team responsible for the assigned process control systems in support of manufacturing ... an empowered team culture including significant interaction with manufacturing, quality and engineering groups.- Supports a spectrum of sophisticated automated… more
- Actalent (Bridgeton, MO)
- …of quality and accountability. Responsibilities + Review and understand batch records , manufacturing protocols, and registration/clinical batch ... Quality assurance experience with a focus on batch record review and GMP compliance. +...in a QA role, specifically in document review of Batch Records , Equipment Records , Validation… more
- ThermoFisher Scientific (Greenville, NC)
- …Cause Analysis to support deviation investigations of moderate to high complexity + Performs quality batch record review + Aids in identification of ... **Job Description** **POSITION SUMMARY** In this position, you'll drive quality execution across the sterile operations including manufacturing, filling, packaging… more
- ThermoFisher Scientific (Greenville, NC)
- …Cause Analysis to support deviation investigations of moderate to high complexity + Perform quality batch record review + Aid in identification of continuous ... **Job Description** **POSITION SUMMARY** In this position, you'll drive quality execution across the sterile operations including manufacturing, filling, packaging… more
- Boehringer Ingelheim (Fremont, CA)
- … Specialist trains junior modelers to learn how to generate batch records , generates and refines batch record creation training materials, and ... batch records in BioMES. Leads team to create new batch record types and systematically evaluate information requirements. + Leads cross functional… more
- Catalent Pharma Solutions (Malvern, PA)
- **Operations Quality Specialist ** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose ... patients annually. Catalent Pharma Solutions is hiring an Operations Quality Specialist . The Operations Quality ...Catalent employee. **The Role** + Review and approve all batch records prior to production to ensure… more
- Catalent Pharma Solutions (Kansas City, MO)
- …the safety of every patient, consumer, and Catalent employee.** **The Role** + Performs batch record review, product release, and disposition + Draft, review and ... ** Quality Assurance Specialist ** **Position Summary** Catalent,...approve technical documents such as procedures or master batch records + Ensures that products are… more
- Actalent (Waunakee, WI)
- …including batch records and log books. + Issue batch records as needed. Essential Skills + Quality assurance expertise. + FDA and GMP compliance ... initiating deviations, and involves reviewing various documents, including executed batch records , cleaning records , and...knowledge. + Experience with batch record review and document control. +… more
- University of Southern California (Los Angeles, CA)
- …facility operation plans and reports, standard operating procedures, and batch records as required. Completes batch record documentation, all appropriate ... cGMP Quality Control (QC) SpecialistApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP- Quality -Control--QC-- Specialist \_REQ20159660/apply) Keck School of Medicine Los… more
- Abeona (Cleveland, OH)
- … systems in support of a cGMP Operation for production processes relating to batch record review and release from start to end of manufacturing activities, ... Position Overview The Specialist II, Quality Assurance performs routine...+ Reconcile issued controlled forms, logbooks, notebooks, master production records , and protocols. + Review batch -related documentation… more
- Abeona (Cleveland, OH)
- … systems in support of a cGMP Operation for production processes relating to batch record review and release from start to end of manufacturing activities, ... Position Overview The Senior Specialist I, Quality Assurance performs routine...Documents include but are not limited to: Master Production Records , Quality Control test methods/forms, Method Qualification/Validation… more
- Charles River Laboratories (Rockville, MD)
- …applicable internal and external requirements. The QA Specialist II will compile the batch record review records and batch disposition documents ... Perform audits and/ or walkthrough of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry… more
- Actalent (Madison, WI)
- …tasks, such as initiating deviations, and reviewing various documents including executed batch records , cleaning records , and log books. Approximately ... Job Title: Quality Assurance Specialist Job Description The...and contribute to problem-solving solutions. + Review and issue batch records , cleaning records , and… more
- Endo International (Rochester, MI)
- …and identify complex errors such as calculation conversions + Able to reconcile batch record entries with other documentation + Proof-reading skills and ability ... serve live their best life. **Job Description Summary** The Quality Associate Specialist , Product Release, under close..., Product Release, under close supervision, reviews all pertinent records , including Batch Production Records … more
- Catalent Pharma Solutions (Philadelphia, PA)
- …clinical production staff within a specific clinical packaging batch record operation. Responsible for safety, quality , production rates, material ... reconciliation, BRNRFT, and timelines adherence in the specific Production Batch Record operation assigned to. This position...room operation. + Responsible for entering data accurately in batch records and logbooks. + Must review… more
