•Issue, review, and approve GMP documentation (e.g., batch records, SOPs, job aids, etc.) needed for internal manufacturing operations. •Review logbooks and reconcile documentation. •Assist with walkthroughs with senior Quality staff members. •Review labeling and packaging batch records and prepare documentation for release. •Review work orders, equipment qualification, and validation documentation for adequacy and compliance. •Review batch record documentation, ensure compliance and accuracy, and prepare for drug substance/product and/or critical material release. •Engage in daily onsite quality oversight and guidance and collaborate across functions, leveraging quality and manufacturing expertise to provide guidance on non-conformance/deviations, troubleshoot/problem solve, interpret data, and apply a risk-based approach for ongoing manufacturing operations and related quality events. •Represent QA in onsite operations from the thaw of starting material to drug substance/product filling and labeling. •Additional duties as assigned. Minimum requirements: o Bachelor's Degree in Biology, Microbiology, Chemistry or related field o 4+ years of experience in cGMP Quality Assurance in Biologics or Cell & Gene Therapy product manufacturing Preferred requirements: o Master's Degree in Microbiology, Biology, Chemistry or a related field o Working knowledge of cell or gene therapy product testing, manufacturing, or development •Demonstrated knowledge of current GMP regulations associated with pharmaceuticals, cell therapies, gene therapies, etc. in the field of responsibility. •Understanding and working knowledge of Quality Management System expectations, ability to interpret requirements, anticipate issues, make informed decisions, and respond rapidly to emerging quality situations. in the field of responsibility. •Local travel between manufacturing sites required. LanceSoft
...At Wells Fargo, we want to satisfy our customers' financial needs and help them succeed financially. We're looking for talented people who will put our customers at the center of everything we do. Help us build a better Wells Fargo. It all begins with outstanding...
...Job Description Description The Instructional Systems Designer will be responsible for designing, developing, and supporting the execution... ...-tiered curriculum that supports contractors - from entry-level professionals with one year of experience to senior experts...
...Concrete Finisher The Concrete Finisher is responsible for finishing concrete pours and other laborer requirements associated with the process. Benefits offered: ~ Highly competitive pay ~ Health insurance, including medical, dental and vision options ~4...
Looking for a Home Inspector job that offers an incredible team and thriving work culture? Look no further!Join our team of dedicated professionals as a full-time Home Inspector and experience the excitement of working in a supportive and positive environment. We are...
Join the family at Progressive Roofing, a leader in the roofing industry with over 40 years of excellence and dedication to quality. We specialize in metal roofing for commercial projects and are seeking a skilled Metal Commercial Roofer to expand our talented team. This...