- Catalent (San Diego, CA)
- …compliant with internal and cGMP regulations;Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents;Liaison between QA ... client, effectively communicates with clients in regards of Executed Batch Records and review status;Tracks...audits, Non-conformance and Environmental Monitoring review , Master Batch Record review and approval,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch records , supporting test records and ... audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager, Quality Assurance Review… more
- Novo Nordisk Inc. (Durham, NC)
- …what matters. The Position Performs quality review & approval of Batch Production Records (BPRs), Change Requests (CR's), Deviations & other documentation ... SOPs Reviews & approves documentation for Quality approval - components/raw material, batch records , change control requests, deviations & validation documents… more
- JobsRUs (Portland, OR)
- …investigations and stability verificationGenerate product testing results reportsReview production batch records (DHR's) for accuracy and completeness in ... system and manufacturing impact.Reviews and verifies compliance of documentation such as batch records , reports of nonconforming materials, inspection records… more
- JobsRUs (Westbrook, ME)
- …II include but are not limited to: in-process andfinal release testing, manufacturing batch record review and approval and data analysis.This job ... QC laboratory equipment according to scheduleReview and approve batch records for next stage(s) of manufacturingWrite/ review Standard Operating Procedures as… more
- Actalent (Rocky Mount, 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...review as they will be focused on ensuring records are meeting quality standards for the company prior… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …intent to correct record errors in manufacturing process documentation that includes batch record review and documentation issue resolution. This role is ... principles are adhered to. ESSENTIAL FUNCTIONS : + Execute batch record review and document...complex calculations and formulas + Ability to focus and review batch records for an… more
- PCI Pharma Services (Bedford, NH)
- …during manufacturing + Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and ... of PCI. **JOB SUM** **M** **ARY** The Quality Associate II - Operations is responsible to provide QA support...Good Documentation Practices + Review executed Manufacturing Batch Records … more
- PCI Pharma Services (Bedford, NH)
- …during manufacturing * Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and ... the future of PCI. JOB SUMMARY The Quality Associate II - Operations is responsible to provide QA support...Good Documentation Practices * Review executed Manufacturing Batch Records … more
- Catalent Pharma Solutions (San Diego, CA)
- …with internal and cGMP regulations; + Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents; + Liaison between ... client, effectively communicates with clients in regards of Executed Batch Records and review status;...audits, Non-conformance and Environmental Monitoring review , Master Batch Record review and approval,… more
- ThermoFisher Scientific (St. Louis, MO)
- …execution as needed. + Perform review process and assign effective dates to batch records and other cGMP documents. + Document all activities to meet cGMP ... commercial and clinical biologics. These support activities consist of issuing and printing batch records , sample labels and other supporting documents used by… 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
- United Therapeutics (Eden Prairie, MN)
- … Records (MBRs), and Test Methods (TMs). Reports errors in a timely and appropriate manner. + Batch Record Review : Perform batch record review ... liver and kidney disease. How you'll contribute The Quality Assurance Specialist II ensures that all intermediates and products manufactured at the Miromatrix are… more
- Mallinckrodt Pharmaceuticals (Hobart, NY)
- …for MRB and CAPA + Perform Change Controls + Identify, implement and execute SOP/Form/ Batch Record revisions + Lead and/or support projects as assigned by the ... Job Title Operations Compliance Specialist II - Second Shift Requisition JR000012567 Operations Compliance... and approval of triages, exceptions, change controls, forms/SOPs, batch records , protocols, etc. Leads and manages… more
- ThermoFisher Scientific (Miami, FL)
- …using safety equipment as needed to complete your daily assigned work. Using batch record instructions, job aids, standard operating procedures, and product ... am* *Shift differential is paid. As a Manufacturing Tech II you are responsible to safely operate equipment to...near miss reports, safety opportunities, accident reports, etc. Use batch record instructions, job aids, standard operating… more
- Catalent Pharma Solutions (Kansas City, MO)
- …- 11:00pm** **The Role:** + Follow safety and manual handling guidelines + Accurately review packaging batch records prior to packaging process to ensure ... **Pharmaceutical Packaging Technician II ** **Position Summary:** Catalent is a global, high-growth,...cGMP + Ensure that any corrections to the packaging batch record are completed accurately + Ability… more
- Ellis Medicine (Schenectady, NY)
- The Accounts Payable Clerk II is responsible for processing payments to vendors for hospital supplies and services. This includes matching appropriate information, ... and preparing checks for distribution. The Accounts Payable Clerk II is also responsible for daily processing of bank...+ Match invoices with receiving and purchase orders. + Review and reconcile invoice discrepancies in a timely manner.… more
- Catalent Pharma Solutions (Morrisville, NC)
- …packaging operations. + Performs line clearances, equipment releases and AQL inspections and real[1]time batch record review on the shop floor. + Assist the ... and perform final review and approval of + executed batch records as required and resolve identified discrepancies and + reported non-conformances. +… more
- PCI Pharma Services (Bedford, NH)
- …used for engineering and cGMP production.** **.** **Prepare and update Master Production Batch records and SOPs accurately for communicating and initiate the ... change process for needed documentation changes** **.** **Completely executed Batch Records accurately prior to submission to...Records accurately prior to submission to supervision for review ** **.** **Comply with all area SOPs and ensure… more
- CVS Health (Glasgow, KY)
- …results. *Performs final production check of completed documents for completeness and accuracy. * Review of completed batch records for compliance with cGMPs, ... for verification of materials and products as directed by procedures and or batch record requirements. *Responsible for labeling, inspecting, and production of… more
