- Actalent (Ontario, CA)
- …testing, including raw material and finished product testing. + Manage document control, batch record review , and quality management systems. Essential ... and corrective actions to maintain the highest quality standards. Responsibilities + Review analytical testing results and ensure proper documentation. + Train and… more
- US Tech Solutions (New Albany, OH)
- …and use of quality systems. + Duties include presence on the shop floor, electronic batch record review , SOP revision approval, work order approval, and ... quality approval of minor deviations and CAPA records . + Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- …quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products ... and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides… more
- Fujifilm (Santa Ana, CA)
- …and follow up actions + Assist with change notification and supplier management + Assist with batch record review or other duties as needed + Assist with ... coordination of quality activities for related FISI production sites **Required Skills/Education:** + **BS/BA in Biology, Microbiology, or Chemistry** + **3-5 years of QA experience in medical device or biopharmaceutical environment** + Must be familiar with… more
- Mentor Technical Group (Juncos, PR)
- …and South America. Responsibilities: + Quality Professional with Manufacturing Process Audit and Batch Record Review experience. + Available for non-standard ... shifts which include nights and weekends. + Basic knowledge of the process, PASx/MES application, MAXIMO, SAP, and LIMS. Education & Qualifications + Bachelor's degree and 5 years of directly related experience or Master's degree and 3 years of directly… more
- West Pharmaceutical Services (St. Petersburg, FL)
- …through directed break schedules. + Work with Quality team to ensure accurate and timely batch record review and provide feedback to necessary parties. + ... Adhere to all company policies. + Must observe all good housekeeping practices. + Performs other duties as assigned based on business needs as directed by Area Manager(s), Production Manager and/or Director, Ops. + Conforms with and abides by all regulations,… more
- Actalent (Orangeburg, NY)
- …+ Review documentation for accuracy before submitting to the QA Release team. + Review Master Batch Records and act as Lead QA Inspector in their ... + Strong ability to interpret and follow SOPs, Work Instructions, Master Batch Records , and product specifications. + Excellent documentation accuracy, attention… more
- Actalent (Wharton, NJ)
- …Strong ability to interpret and follow SOPs, Work Instructions, Master Batch Records , and product specifications. Excellent documentation accuracy, attention ... Review documentation to assure accuracy prior to submittal to QA Release team. Review Master Batch Sheets. Act as Lead QA Inspector in his or her absence to… more
- Actalent (Parsippany Troy Hills, NJ)
- …with cGMPs and GLPs. + Conduct and document major and minor deviation investigations. + Review Executed Batch Records for Biologics DS and DP. + Participate ... document deviation investigations related to GxP operations and perform reviews of Executed Batch Records for Biologics Drug Substance (DS) and Drug Product… more
- CGI Technologies and Solutions, Inc. (Detroit, MI)
- … the amount and type of fee collected, all according to established procedures. . Review and batch applications not received from the lockbox. . Verify and cash ... the type of application submitted, notes all discrepancies and records the amount and type of fee collected. Due...all work brought to the office, ensuring that each batch balances before beginning new batch . .… more