- Merck & Co. (Rahway, NJ)
- …and seamless technology transfer to commercial sites. The SSO Operations Specialist will provide hands on assistance for daily production activities while ... This position is also responsible for ensuring facility readiness for batch processing and shares accountability for the building performance. Ultimately, this… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …coordination and execution of process and equipment improvement initiatives, reviews completed quality records , generates quality deviation responses, drive ... on the manufacturing process and QMS systems Revise and create documentation (SOP, batch records , FT's) associated with the manufacture of product, requiring… 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 ... Legend Biotech is seeking an Operations Support Specialist as part of the Technical Operations team...on time in a manner consistent with safety policies, quality systems, and cGMP requirements.Build strong partnerships with Manufacturing,… more
- Merck & Co. (Durham, NC)
- …team and shop floor to with defining the requirements of the electronic batch record and successful executionCollaborates with the maintenance technicians and ... Job DescriptionSenior Maintenance Specialist P2 DaysPrimary ResponsibilitiesReporting to the Associate Director of Maintenance and Engineering or the shift… more
- West Pharmaceutical Services (Kinston, NC)
- Quality Specialist , Batch Record Requisition ID: 69645 Date: May 27, 2025 Location: Kinston, North Carolina, US Department: Quality Description: At ... for internal and external customers as well as supporting post-production related Quality activities such as finished batch release, including sterilization,… more
- Boehringer Ingelheim (Columbus, OH)
- …of 2-3 days per week on-site.** **Duties & Responsibilities** + Independently performs batch record review and/or final disposition of drug products manufactured ... and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Specialist III, Batch Disposition is responsible for ensuring that batches… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Quality Assurance Specialist position. This position performs activities supporting dispositioning product and/or raw ... materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron...advice in alignment with QA policies + Reviewing completed records and batch sheets and working with… more
- Catalent Pharma Solutions (Harmans, MD)
- …therapies and vaccines. **Position Overview:** The Lead Specialist , QA Batch Disposition is responsible for providing Quality Assurance support for ... documentation practices (GDP), including but not limited to: executed batch records , master batch ...of cell and gene therapy products. + Independently executes batch record review for completeness, accuracy and… more
- Catalent Pharma Solutions (Harmans, MD)
- …in accordance with good documentation practices (GDP), including but not limited to executed batch records , master batch records , product labels, SMPs, ... **Job Title:** Senior Specialist , QA Batch Disposition **Location:** Harmans,...of cell and gene therapy products. + Independently executes batch record review for completeness, accuracy and… 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
- 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
- Endo International (Cranbury, NJ)
- …everyone we serve live their best life. **Job Description Summary** The Quality Specialist performs routine collection of environmental and utility monitoring ... samples. This role also reviews all pertinent records , including Batch Production Records ...errors such as calculation conversions + Able to reconcile batch record entries with other documentation +… 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
- System One (Pittsburgh, PA)
- …a cutting-edge GMP environment. You'll create and manage SOPs, batch records , and controlled documents using an electronic quality management system (eQMS), ... and Gene Therapy! We are seeking a QA Document Specialist to manage critical documentation and support quality...Editing: Create, format, and edit Standard Operating Procedures (SOPs), batch records , and other forms according to… more
- The US Pharmacopeial Convention (USP) (Frederick, MD)
- …as a key member of the Reference Standards Production (RSP) team. The Production Quality Specialist plays a pivotal role in the production of USP Reference ... prepare, review and issue required documentation and production instructions such as batch records , primary and secondary package labels, and change… more
- Kelly Services (Fort Washington, PA)
- …office and other systems to improve business effectiveness + Exposure to electronic batch records and/or other automated processes/systems (labs). + Basic SAP or ... ** Quality Assurance Specialist ** Kelly(R) Science &...workorder evaluation. + Performs or supports activities related to Batch Record Review, Raw Material, Bulk, +… more
