- Merck & Co. (Durham, NC)
- …in Aseptic processing, aseptic observations, and techniques.Electronic manufacturing batch records (eMBR) experience.NOTICE FOR INTERNAL APPLICANTSIn ... lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist will support this expansion. Project activities… more
- Novo Nordisk Inc. (Durham, NC)
- …& approves documentation for Quality approval - components/raw material, batch records , change control requests, deviations & validation documents Performs ... Nordisk and help us make what matters. The Position Performs quality review & approval of Batch Production Records (BPRs), Change Requests (CR's), Deviations… more
- Novo Nordisk Inc. (Durham, NC)
- …with Regulations, ISO standards, corporate & local SOPs Reviews & approves documentation for Quality approval - batch records & other documentation Supports ... make what matters. The Position Ensures Batch Production Records (BPRs) & relevant quality processes are compliant with regulations. Performs quality … more
- Merck & Co. (Rahway, NJ)
- …independent problem-solving.Preferred Experience and Skills:Experience or interest in supporting electronic batch records and MES systems.Ability to convert new ... clinical supply manufacturing facility in Rahway, New Jersey.The Process Engineer role at the Specialist level will serve as a leader in the FLEx Oral Solid Dosage… more
- Catalent (Manassas, VA)
- …with complex formulations to help create engaging new products consumers will love.The Quality Assurance Specialist I - Quarantine is responsible for auditing ... of production and packaging to ensure adherence to company quality standards. Communicate any deviations to management. Assist the...timely completion of all tasks relating to issuance of Batch production records and maintenance of cGMP… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …NNUSBPI products. This position has QA signature authority on the review of individual batch records , supporting test records and other ancillary support ... to certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular… more
- Catalent (Manassas, VA)
- …soft chews for nutritional supplements and nutraceuticals, as well as small batch lozenges. With extensive development and manufacturing expertise and a wide range ... formulations to help create engaging new products consumers will love.The Document Control Specialist - 2nd Shift is responsible for creating and maintaining the … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …NNUSBPI products. This position has QA signature authority on the review of individual batch records , supporting test records and other ancillary support ... with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk through audits of the facility, and deviation issues Assists in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems. Experience authoring and executing documentation including but not limited to: Batch Records , SOPs, Work Instructions, protocols. Experience with SAP, ... the treatment of multiple myeloma. Legend Biotech is seeking a Systems Engineer Specialist as part of the Commissioning and Qualification team based in Raritan, NJ.… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …coordination and execution of process and equipment improvement programs, reviews completed quality records , generates quality deviation responses, drive ... on the manufacturing equipment and processes Revise and create documentation (SOP, batch records , reports) associated with the manufacture of product, requiring… more
- Aequor (Bothell, WA)
- …MES Recipe Engineer and Validation Specialist role will deliver electronic batch record (EBR) configuration and validation in the Emerson Syncade ... MES. ROLES AND RESPONSIBILITIES: Collaborate with Manufacturing, Supply Chain, Quality , Facilities and Tech Transfer departments, capturing and documenting detailed… more
- Actalent (Wilson, NC)
- Description: The Batch Record Quality Specialist II will be responsible for conducting thorough reviews of manufacturing batch records for ... information is allocated into the proper sections of the record . These individuals will be doing a less technical...technical review as they will be focused on ensuring records are meeting quality standards for the… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Quality Assurance Specialist ( Batch Disposition) 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 Standard Requirement Documents. In… 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
- Danaher Corporation (Duncan, SC)
- …of solutions that safeguard and improve human health. What you'll do: + Review batch documentation records to ensure goods are being released in compliance with ... Bachelor's degree or 1-3 years of experience in a quality and production environment + Good knowledge of ...quality and production environment + Good knowledge of quality standards: GMP Requirements, Good Documentation Practices + Excellent… more
- WellSpan Health (Chambersburg, PA)
- …system, analyzes, unitizes, answers phones, purges for microfilm, and scans patient records ( batch prep, acquisition, indexing, quality assurance, etc.). ... Medical Records Specialist Location: Chambersburg Hospital, Chambersburg,...the Meditech system and attaching miscellaneous reports to the record . 13. Batch preps records … more
- Mallinckrodt Pharmaceuticals (Hobart, NY)
- …tracking in the Batch Record Activity Tracker (BRAT), of all batch records through the Manufacturing and Packaging process (as applicable). + Coordinate ... review of medium to high complexity for all manufacturing batch records at appropriate stages in order...including coaching and mentoring operators and technicians on proper batch record documentation. + Lead and participate… more
- Integra LifeSciences (Cordova, TN)
- …, Quality Assurance (QA) is responsible for batch record release, donor record / batch record quality reviews, all quality record ... for quality assurance metrics and maintaining all quality records / batch records ...safely to finished goods for final distribution + Perform batch record review and release for all… more
- Mallinckrodt Pharmaceuticals (Hobart, NY)
- …tracking in the Batch Record Activity Tracker (BRAT), of all batch records through the Manufacturing and Packaging process (as applicable). + Prioritizes ... review of medium to high complexity for all manufacturing batch records at appropriate stages in order...including coaching and mentoring operators and technicians on proper batch record documentation. + Assists in training… more
- Actalent (Bedford, MA)
- …area! **Must have quality assurance experience as well as CAPAs, Batch Record Review, investigations, deviations experience** If interested, please reach out ... audit activities as assigned. + Issue, review and reconcile batch records as needed. Skills: Quality...Skills: Quality assurance, Compliance, GMP, Document control, Batch Record , Batch Record… more
