management of quality issues and CAPAs Participate in internal cGMP audits, support regulatory inspections, perform disposition... control Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP...
activities while maintaining strict adherence to Current Good Manufacturing Practice (CGMP), quality and regulatory standards... environment; or Associate degree in life science, engineering, or relevant technical field with 4+ years of experience in a CGMP...
as required by supervision. Essential Skills Proficiency in batch record review and sampling. 3-5 years of quality/quality control.../production experience in a cGMP facility. Associate degree in life science or related field with completion of 4 college-level...
, and Quality Control to support their individual department needs related to the CCMS/CMMS. Meet with internal customers..., such as manufacturing operators, engineers, maintenance and calibrations technicians, validation, quality, and external suppliers to provide...
activities while maintaining strict adherence to Current Good Manufacturing Practice (CGMP), quality and regulatory standards... environment; or Associate degree in life science, engineering, or relevant technical field with 4+ years of experience in a CGMP...
in safety standards and quality control procedures. Experience with computerized batch record systems or manufacturing... quality, and conducting filtration and sanitization procedures to maintain a sterile and contamination-free environment...
Assurance, Quality Control, Operations, Engineers, OEM providers, as well as internal equipment owners and operators..., Operations, Automation, Validation and Quality department personnel, and with the various contractors and consultants working...
, Beckhoff, or similar PLC/HMI platforms. Knowledge of cGMP, data integrity, and change control processes. Experience... to equipment commissioning, upgrades, and validation activities. This role works closely with Operations, Maintenance, Quality...
To: Associate Direcotor, EHS Salary Range: $72,800 - $93,600 Summary The EHS Lead is responsible for developing, implementing... 300/300A recordkeeping, annual posting, and incident classification. Risk Assessment & Hazard Control Lead JHAs/JSAs...
while maintaining strict adherence to Current Good Manufacturing Practice (CGMP), quality and regulatory standards. Flexibility... of experience in a CGMP manufacturing environment; or Associate degree in life science, engineering, or relevant technical field...
. Strong knowledge of cGMP documentation and change control systems including experience with DCM. Proficient in SAP ERP system... experience with cGMP documentation. Knowledge of SAP Bills of Materials required. Preferable experience in Regulatory and Quality...
, and Quality System policies. Support Deviation Management, CAPA, and Change Control activities, as required. Performs... of what’s possible in Cell & Gene Therapy. This role reports to the Associate Director of Automation, Equipment, and Processes. Key...
shift comply with Current Good Manufacturing Practice (CGMP) and other safety or quality standards. Flexibility with working... manufacturing environment; or Associate’s degree in life science with 6+ years of experience in a CGMP manufacturing environment...
and efficiently meet requirements and targets for environmental control, Sustainability, EHS and data retention. Ensure safety...; OR a Master’s degree with 2 years of relevant experience; OR an Associate's degree with 8 years of relevant experience; Or a Ph...
while maintaining strict adherence to Current Good Manufacturing Practice (CGMP), quality and regulatory standards. Flexibility... of experience in a CGMP manufacturing environment; or Associate degree in life science, engineering, or relevant technical field...
staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a lead... operational plans to achieve center performance targets related to donor throughput, quality, and productivity. Partners...
activities while maintaining strict adherence to Current Good Manufacturing Practice (CGMP), quality and regulatory standards... environment; or Associate degree in life science, engineering, or relevant technical field with 4+ years of experience in a CGMP...
shift comply with Current Good Manufacturing Practice (CGMP) and other safety or quality standards. Flexibility with working... manufacturing environment; or Associate’s degree in life science with 6+ years of experience in a CGMP manufacturing environment...
and encourage development of direct reports. Ensure compliance with regulatory and company requirements, including SOPs, cGMP..., safety, quality, OSHA, emissions regulations and other standards. Assist in procurement of import utilities, including...
in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety... with cGMP. ACCOUNTABILITIES Perform duties associated with Training (including but not limited to): (40%) Maintains complete...