- Cipla (Hauppauge, NY)
- …generated during batch process and accountability in the batch record . Review of engineering records (temperature and humidity data, calibration ... training assigned and follow company policies, safety requirements, cGMP and SOP's. Review of online batch records , area/equipment logbooks, calibration/PMP… more
- Cipla (Hauppauge, NY)
- …generated during batch process and accountability in the batch record . Review of engineering records (temperature and humidity data, calibration ... batch manufacturing and packaging, as per manufacturing & batch packaging record instructions. Collection of in-process...and follow company policies, safety requirements, cGMP and SOP's. Review of online batch records ,… more
- Cipla (Hauppauge, NY)
- …generated during batch process and accountability in the batch record . Review of engineering records (temperature and humidity data, calibration ... batch manufacturing and packaging, as per manufacturing & batch packaging record instructions. Collection of in-process...and follow company policies, safety requirements, cGMP and SOP's. Review of online batch records ,… more
- Endo International (Hobart, NY)
- …ensures the successful day-to-day operations of Quality Assurance department including QA Operations ( batch review ), QA Label Control (label review ), QA ... + Able to read, comprehend, and make appropriate alterations to documents such as batch records , quality agreements, SOPs, etc. + Actively takes the lead in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support manufacturing to ensure sterility of the product/process is not compromised.Support batch review & material release in SAP for In-house reagents.Support ... prior to use on the manufacturing floor.Utilize multiple electronic quality systems, batch records and SAP.Work in a team based, cross-functional environment… more
- Cipla (Fall River, MA)
- …but are not limited to the following : Works with Manufacturing/Packaging to deliver timely batch record review across all shifts. Reviews and approval of ... master batch records . Develops appropriate disposition metrics, works...and SOP's. Knowledge of GDP. Creation and maintenance of batch record and cGMP documentation templates. Closure… more
- Merck & Co. (Durham, NC)
- …compliance with cGMP, regulations, and our Company's Quality Management System focusing on batch record review , process/aseptic observations, critical site ... Leads and Supports the Aseptic Observer Program (AOP) and Batch Record Review (BRR) workstreams...Management. Experience with Kneat, Veeva Vault, MEDS, SAP, Electronic Batch Records (MES), Trackwise and GLIMS. RCA… more
- Tolmar (Windsor, CO)
- …Procedures (SOPs) and Production Batch Records . Assist with Batch Record review , as necessary, including prioritization, reviewing corrections, ... and CAPA implementations for non-conforming events. Pre-approve expiration dates on batch records prior to manufacturing. Perform functional area management… more
- Tolmar (Fort Collins, CO)
- …Operating Procedures (SOPs) and Production Batch Records . Performs Batch Record review , including prioritization, reviewing corrections, and ... and CAPA implantations for non-conforming events. Pre-approves expiration dates on batch records prior to manufacturing. Performs other related duties… more
- Aequor (Thousand Oaks, CA)
- …for training. The position supports commercial drug substance production and requires cleanroom oversight, batch record review , and acting as a QA liaison ... and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review , SOP revision & approval, work order approval,… more
- Tolmar (Fort Collins, CO)
- …and qualification of all direct reports before duties are assigned. Ensures the batch record review process, including prioritization and reviewing ... including but not limited to: line orientation and risk review of all new team members or those transferring....prevent recurrences of a non-conformance. Pre-approves expiration dates on batch records prior to start of manufacturing… more
- Endo International (St. Louis, MO)
- …out lot isolation forms + Update items in BPCS for the in process lab personnel + Review batch records as a backup or if required for shipping needs ... recording correct DOM + Serve as a resource regarding batch record linkage for all special products...complex calculations and formulas. + Ability to focus and review batch records for an… more
- bioMerieux Inc. (Lombard, IL)
- …are met for various Quality systems. The position will act as administrator for batch record review , document control, training, and audits. Specialist will ... in association with bioMerieux's policies. Primary Duties Perform Quality review of lot batch records for good documentation requirements and paperwork… more
- Cipla (Central Islip, NY)
- …with safety, quality, productivity, and performance expectations and execution of manufacturing operations. Review batch record after finishing each step for ... to include delivery, in-process samples in a defined schedule. Review and compile the documents generated during the production...during the production of tablets and capsules such as Batch Manufacturing Record (BMR), PQ protocol. Perform… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …onco-dermatology. **Job Summary:** The Quality Assurance Specialist is responsible for the batch certification review of site QA activities related to ... manufacturing and packaging records , as well as all supporting documentation. This includes...regulatory, corporate, and internal audits. **Key Responsibilities** + Support batch certification activities for commercial distribution in the USA… more
- Curia (Springfield, MO)
- …Good Documentation Practices when completing GMP related documents such as Master Batch Records , SOP and Operating Manual requirements, equipment operation, ... trained on the changes. Ensure compliance with all safety rules, procedures, batch records and work instruction through constant reinforcement of expectations… more
- Cipla (Hauppauge, NY)
- …and PM records , Pest control records and contractor related functions). Review of online batch records in terms of completeness of signatures, ... batch record . Monitor facility and product environmental operating conditions. Review of engineering records (temperature and humidity data calibration… more
- Cipla (Hauppauge, NY)
- …and PM records , Pest control records and contractor related functions). Review of online batch records in terms of completeness of signatures, ... batch record . Monitor facility and product environmental operating conditions. Review of engineering records (temperature and humidity data calibration… more
- International Flavors and Fragrances (Clackamas, OR)
- …work orders (eg cleanings, set-up, beginning of runs, ends of runs, etc ) Review batch records and associated documentation for completeness, legibility, and ... correctness. Work with quality control to effectively identify, document, and help resolve quality and production issues as needed. Accurately document any out of specification conditions per established procedures. Accurately track work orders internally… more
- ImmunityBio (El Segundo, CA)
- …operations. Essential Functions Performs manufacturing activities according to cGMP guidelines, including batch record execution and review , product and ... to read, understand and apply Standard Operating Procedures (SOPs) and Manufacturing Batch Records (MBRs) Working Environment / Physical Environment This… more
