- Insmed Incorporated (San Diego, CA)
- …participate in the process execution within a Pilot Plant non-GMP manufacturing environment. Review batch records , SOPs, raw material specifications, ... IND, NDA, or equivalent regulatory submissions.Must be familiar with BSL- II lab safety requirements.Participate in multi-disciplinary projects with multi-cultural… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose The Batch Record Reviewer II audits Manufacturing ... and coordinates problem-solving activities, including solution implementation. Responsibilities + Review and audit the data and records ...Operations in the processing of a material or product batch + Ensure any batch record… more
- Mallinckrodt Pharmaceuticals (Raleigh, NC)
- …Daily Notification to Management. They provide support for customer inquiries, gap assessments, batch record review , and label preparation as assigned. ... Job Title Quality Analyst II Requisition JR000014866 Quality Analyst II ... records to including but not limited to, batch record scanning, documentation error tracking and… more
- The Ritedose Corporation (Columbia, SC)
- …is compliant with all TRC, client, and regulatory agency requirements. Responsibilities: + Batch record review for completeness, accuracy, and compliance to ... product Certificate of Analysis or Conformance + Track/trend the batch record review process- identify...+ New Hire (level 1): Complete initial training and review level 1 batch records .… more
- Curia (Albuquerque, NM)
- …primary quality assurance contact for CURIA-Albuquerque clients + Responsible for ensuring batch records have been thoroughly reviewed before product disposition ... improvement initiatives + Will provide quality training related to batch review , sitewide + Read/interpret SOPs to...pressure to meet customer and business deadlines associated with batch record lot release Other Qualifications: +… more
- Novo Nordisk (Bloomington, IN)
- …to solve issues presented in BRs during Analyst review + Assists QA Batch Record Review with Client Observations, including priority observations from QA ... of all types of GMP Documentation including Master Batch Records , Engineering Studies, Logbooks, Forms, etc....specific area for the purpose of material readiness, and record review + Assists supply chain in… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and PM records , Pest control records and contractor related functions) + Review of online batch records in terms of completeness of signatures, ... detailed written procedures. Conduct in process testing per manufacturing and packaging batch record instructions. Prepare controlled / uncontrolled / packaged… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and PM records , Pest control records and contractor related functions) + Review of online batch records in terms of completeness of signatures, ... detailed written procedures. Conduct in process testing per manufacturing and packaging batch record instructions. Prepare controlled / uncontrolled / packaged… more
- Abeona (Cleveland, OH)
- …of the quality systems in support of a cGMP Operation for production processes relating to batch record review and release from start to end of manufacturing ... Position Overview The Specialist II , Quality Assurance performs routine activities associated with...+ Reconcile issued controlled forms, logbooks, notebooks, master production records , and protocols. + Review batch… more
- Catalent Pharma Solutions (Harmans, MD)
- …**Specialist II , MTO** will provide support to Manufacturing Associates to meet batch record review /disposition schedule to adhere to lot release dates. ... **Specialist II , MTO** **Summary:** _Catalent, Inc. is a leading...and revising GMP documents such as SOPs and Manufacturing batch records . **This is a full-time on-site… more
