- Cipla (Hauppauge, NY)
- …General: 8:30AM - 5:00PM (may vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - $74,600 Purpose: The incumbent to this ... working outside of Cipla's US Subsidiaries or Affiliates. Job Title : QA Validation FLSA Classification : Professional, Exempt Work Location : Unit 1, Hauppauge, NY… more
- Insmed Incorporated (San Diego, CA)
- …strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV SOPs and ... Work Instructions Coordinate all validation activities with outsourced validation vendor when managing cloud applications. Manage and provide oversight on… more
- ValSource, Inc. (Rahway, NJ)
- …industries throughout each of our regions in the US. The Commissioning, Qualification & Validation (CQV) Project Manager will interface with our clients and be ... used in the FDA regulated pharmaceutical and biotech manufacturing industries. Project Manager is responsible for managing and executing validation projects… more
- Cipla (Fall River, MA)
- Job Title : Mfg. Validation Engineer FLSA Classification : Professional, Exempt Work Location : Fall River, MA Work Hours: General Shift: 8:30AM - 5:00PM (may vary ... based on business needs) Reports To : Manufacturing Manager Salary Range: $62,400 - $75,400 Purpose: The content and statements documented in this job description… more
- Endo International (St. Louis, MO)
- …much or all of the time. **ORGANIZATIONAL RELATIONSHIP/SCOPE:** Reports to the Manager Quality Validation . Must be self-directed to manage validation ... we serve live their best life. **Job Description Summary** The Lead Validation Engineer will create, review and/or execute primary qualification and validation… more
- Insmed Incorporated (NJ)
- …will include, but not necessarily limited to the following: Develop risk-based validation strategies for system implementation and changes following CSV SOPs and ... Work Instructions Coordinate all validation activities with outsourced validation vendor when managing cloud applications. Manage and provide oversight on… more
- BioAgilytix (San Diego, CA)
- …you enable life-changing, life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of ... and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing a key role in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking MES Project Manager as part of the Manufacturing Excellence team based in Raritan, NJ.Role ... OverviewThe MES Project Manager will be part of Manufacturing Science and Technology...including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT.… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The Role The Senior Manager , Biostatistics acts as a biostatistician supporting the clinical development of compounds as ... business partners in collaboration with the programmer and the data manager , as applicableCTT member:Participate and represent BiostatisticsReview and provide input… more
- ACROBiosystems Inc. (San Jose, CA)
- …support drug development and clinical applications from target discovery and validation , candidate drug screening and optimization, CMC development, preclinical and ... collaboration and continuous learning. Job Summary The Associate Regional Manager will lead commercial activities across Northern California, driving growth… more
- Aequor (Parsippany, NJ)
- …to ensure rebate eligibility and data consistency.20% Perform Claim Level Detail validation . Review suspect claim records and determines if record should be disputed ... Complete Medicaid analyzes and documentation on assigned states/programs. Communicate to manager for key findings and changes to state programs.10% Provide backup… more
- ValSource, Inc. (Worcester, MA)
- …not limited to: Reporting to the clients Process Engineering or Area Manager , while demonstrating independent drive and sound judgment in day-to-day operations at ... with representatives from Process Engineering, Automation, Commissioning, Qualification & Validation (CQV) and others to drive projects through capital management… more
- Merck & Co. (Durham, NC)
- …Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control ... tools and calibration equipment)- Assist with execution of calibration, automation, validation and additional testing, as required Decisions are guided by policies,… more
- Cipla (Fall River, MA)
- …water generation, storage, and distribution system. Participate in qualification and validation activities for effective implementation of validation master ... completeness. Report all issues that arises to the department head or reporting manager . Maintain discipline in department. May be required to assist in the training… more
- Cipla (Fall River, MA)
- …5:00PM (may vary based on business needs) Reports To : Quality Assurance Manager Salary Range: $72,800 - $93,600 Purpose: The QA operation specialist (MDI) position ... Quality Team. The QA operation specialist (MDI) monitors and ensures validation and qualification of facility, utilities, equipment's, processes and ensure product… more
- Merck & Co. (NC)
- …Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation . The Utility Specialist Engineer is a member of the Plant ... guided by policies, procedures, and business plan; receives guidance from manager Provides technical guidance to employees, colleagues, or contractors Anticipates… more
- BioAgilytix (Durham, NC)
- …to the patients who need them.Essential ResponsibilitiesServe as Bioanalytical Project Manager on a project (BPM)/Principal investigator (PI)May prepare and submit ... of deviationsPerform assays according to GLP guidelinesFollow GLP guidelines for validation of assays - run assays independentlyPrepare worksheets independently -… more
- Cipla (Fall River, MA)
- …- 5:00PM (may vary based on business needs) Reports To: Quality Assurance Manager Salary Range: $78,000 - $99,840 Purpose This position requires a strong analytical ... standard operating procedures (SOPs) and test procedures. Verifying process validation and characterization-related documents. Coordinating with the Regulatory Affairs… more
- Aequor (Northborough, MA)
- …support from the Quality Assurance, Materials Management, Facilities Engineering, Validation , Metrology and Manufacturing Technical Support groups. In addition, ... Follow operational procedures and both written and verbal instructions from the supervisor/ Manager . Perform manual packaging on an assembly line. Ability to lift up… more
- Insmed Incorporated (San Diego, CA)
- …expand what's possible for patients with serious diseases. Reporting to the Senior Manager , Quality Control, you'll be involved in transfer of method from Analytical ... Control Senior Research Associate will author and execute phase appropriate qualification/ validation protocols and reports of QC methods to support product release,… more
