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Job Details

Quality Control Analyst II or Senior Analyst Raw Material and Sample Management

Location
South San Francisco, CA

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**MEMBERS ONLY**SIGN UP NOW***. Therapeutics (NASDAQ:BOLD) is a biotechnology company committed to the development and commercialization of innovative new gene therapy treatments for people with serious rare diseases. We believe gene therapy technology has tremendous potential as a treatment approach for many genetic diseases. We currently have four programs in development for the treatment of X-Linked Myotubular Myopathy (XLMTM), Crigler-Najjar Syndrome, CASQ2-related Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) and Pompe disease. We are a focused, experienced and passionate team driven by the goal of improving the lives of patients.
**MEMBERS ONLY**SIGN UP NOW***. takes pride in strong, global relationships with the patient, research, and medical communities, and we take equal pride in carefully selecting our colleagues. If you believe you match what were looking for, wed love to hear from you. Our compensation philosophy embodies what youd expect from an innovative life sciences employer competing for the best talent available.
Listed below is a current opening for which we are seeking smart, driven, experienced, and just plain good people to join us in realizing our mission.
The Role
**MEMBERS ONLY**SIGN UP NOW***. Therapeutics is seeking a QC Analyst with experience in managing GMP raw materials (RMs) at our cGMP facility located in South San Francisco. Reporting to the QC Supervisor, the Quality Control Analyst II or Sr. Analyst is responsible for material inspections, sampling, and testing support in compliance with cGMP requirements. This role also will support QC sample management for GMP raw materials and QC samples (In-process, DS, and DP).
Specific responsibilities include but are not limited to:
Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures
Manage Raw Material qualification
Develop and review non-compendial method qualification protocols and reports
Create and/or revise SOPs and RM specifications
Cross functional communication and routine interaction with stakeholders or various departments for oversight of in-coming QC raw materials
Coordinate with all contract testing laboratories (CTLs) for QC RM testing activities including but not limited to: obtaining quotes and POs, scheduling testing and shipments to meet timelines
Manage data packages from CTLs for meeting timeline: tracking sample shipments, monitoring test process, creating data packages and ensuring data review accuracy
Implement and manage appropriate QC systems for data compliance and data management
Participate in deviation investigations related to QC RM and CTL data results
Team player with the ability and willingness to support other colleagues in the Quality Control department through cross training as needed
Additional activities, as required
Required Education, Skills and Experience
BS or BA degree in Biological Science or other relevant degree, with a minimum of 2-3 years (Analyst II) or 4-5 years (Sr. Analyst) related experience in raw material and bio-pharma, plus 1-2 years (Analyst II) or 3-5 years (Sr. Analyst) of relevant industry experience in a quality control role
Technical knowledge and experience in relevant areas of 21CFR, ICH, USP, Ph. Eur. and FDA guidance documents as well as cGXPs in support of clinical and commercial manufacturing
Proven knowledge in cGMP raw material program (RM sampling plans and testing requirements)
Excellent project management and organizational skills, with attention to detail
Excellent oral and written communication skills. Ability to communicate professionally with vendors, internal customers and sales professionals regarding quality issues
Demonstrated proficiency in Microsoft Office suite
Proven ability to handle multiple tasks concurrently, and in a timely fashion
Outstanding interpersonal skills, highly collaborative within a multi-discipline team and contribute to a supportive and positive work environment
Dedicated and self-motivated and engaged to learn new methodologies or provide recommendations for optimization
Must be willing to work second shift, rotating shifts, overtime, weekends, and holidays, as required
Preferred Skills and Experience
Technical knowledge with a variety of analytical techniques
Experience working in a GMP Raw Material Control group desired

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