Quality Assurance Specialist, CMC 10/8/2017
San Diego, CA
JOB DESCRIPTIONAPPLY About
Samumed is a pharmaceutical platform company based in San Diego, California, focused on advancing regenerative medicine and oncology applications through research and innovation (www.samumed.com). Samumed has discovered new targets and biological processes in the Wnt pathway, allowing the company to develop small molecule drugs that have the potential to address numerous degenerative conditions as well as many forms of cancer. Samumed is currently conducting clinical trials for multiple disease areas, including oncology, osteoarthritis, androgenetic alopecia, tendinopathy, degenerative disc disease, and idiopathic pulmonary fibrosis, and it has a broad pipeline targeting areas of significant unmet medical need.
Job Description and Responsibilities:
Samumed is looking for an experienced and talented Quality Assurance Specialist, CMC, to join its Quality Assurance team. This position will be primarily responsible for reviewing CMC documents related to phase 1-3 investigational products, such as manufacturing and packaging and labeling batch records, method validations, and testing records. In addition, this position will participate in compliance activities, such as deviations and investigations, CAPAs, and audits. This position will be based in Samumed s San Diego office. Specific responsibilities of the position include:
Conducting review and approval of API and finished drug product manufacturing, and packaging and labeling batch records from contract organizations
Reviewing release test results for API and finished drug product, and issuing certificates of analysis
Performing product disposition according to established procedures
Interfacing with contract manufacturers and testing laboratories to communicate and promptly resolve quality issues
Reviewing and approving SOPs, test methods, specifications, protocols, reports, and other documentation related to CMC manufacturing activities
Participating in change controls, deviations, OOS and CAPAs associated with manufacturing, packaging and labeling, and shipping activities
Reviewing pertinent CMC sections of regulatory filings
Participating in vendor management program in activities, such as providing feedback on (i) planning and conducting of vendor audits, (ii) any quality or compliance concerns from interactions with CMOs, (iii) review of vendor audit agenda, (iv) review of vendor audit reports, and (v) any post-audit tasks assigned, such as review/follow-up on vendor s CAPAs.
Reviewing and approving protocols and reports associated with stability, method validation, and method transfer.
Implementing and maintaining vendor quality agreements
Executing other tasks assigned by Head of Quality or designee