Qa Gmp Contractor Jobs

Astex Pharmaceuticals, Inc. (“Astex”) is committed to the fight against cancer. Astex is developing a proprietary pipeline of novel therapies for the treatment of solid tumors and hematological malignancies and has several products being developed in collaboration with leading pharmaceutical companies. Astex is a member of the Otsuka group of pharmaceutical companies. which also includes Taiho Pharmaceutical and Taiho Oncology. We are looking for a motivated professional interested in applying their unique skills to our shared mission. Our office is located in Pleasanton, California in the Rosewood Commons campus near the Dublin-Pleasanton BART station.

The QA GMP Contractor will be responsible for performing the day-to-day Quality operations for the Quality Assurance (QA) department within the Quality organization, including tracking change controls, tests method validation protocols/reports, stability protocols/reports, manufacturing records, associated deviations, and investigations. They will be responsible for developing stability studies and updating stability results into the IStability system. This individual will also be responsible for representing Quality Assurance as the Analytical lead in Project Development Teams. PLEASE NOTE: This is not a remote position. It is an onsite role that will be based in Astex’s Pleasanton, CA office.

The hourly rate range for this position is $100 – $125. In Colorado, the hourly rate range is $85 - $105. Compensation will be determined by considering several factors including but not limited to the contractor’s geographic location, education, skill set, and experience.

Responsibilities:

• Collect relevant Quality documents for QP’s release
• Responsible for the administration and maintenance of electronic quality systems (istability, TrackWise)
• Support Quality System (TrackWise) within all active modules (Deviations, Change Control, Complaints, CAPA and Audit) across Astex compounds in development.
• May perform other related duties as required and/or assigned.
• Manage CMO Quality documents within SharePoint
• Revise Quality documents (SOP and Guidelines) to drive and support in-house continuous improvement including streamlining processes and maintaining GMP compliance
• Support departmental projects and Quality working teams when required
• Initiate follow-up on investigations, deviations and corrective action(s) generated during annual audit, for-cause audit, and qualification audits
• Provide support for vendor management activities
• Manage and support analytical and technical functions within the Quality Assurance department.
• Track and prepare update reports for critical Quality metrics; CMO audit, change controls, deviations, CAPAs internal and external
• Manage the stability programs using both paper based and electronic stability management system (IStability)

Qualifications:

• Working knowledge of QA/QC principles
• Bachelor’s degree in chemistry or life sciences
• Minimum 5 years’ experience in a GMP Quality Assurance/Quality Control/Manufacturing environment
• Ability to understand and successfully execute detailed written instructions
• Working knowledge of Analytical Chemistry and Microbiology
• Exceptional oral and written communication skills
• Demonstrated accountability, dedication to quality, and attention to detail
• Proficiency using MS Office, TrackWise, Learning Management System (LMS), Stability Management Systems (IMS), Electronic Document Management System (EDMS) and SharePoint
• Knowledge and training in GMP/GLP/ISO guidelines