Quality Assurance Specialist
South San Francisco, California
Permanent (Full time)
FibroGen seeks a Quality Assurance Specialist to support the manufacture of drug product at contract manufacturing organizations (CMOs). The successful candidate's primary responsibility will be to assure the compliance and quality of FibroGen's drug product manufacturing operations with respect to FibroGen's procedures and requirements, and applicable domestic and international regulatory expectations and requirements. The position involves quality review of batch records and related records (., deviations, change controls) in advance of batch disposition for all phases of programs from clinical to commercial. Responsibilities: The successful candidate will be a primary reviewer of GMP production records at FibroGen. The position will require regular interaction with QA management at both FibroGen and contract manufacturing organizations (CMOs) on matters concerning the product quality and CMO GMP compliance. This includes, but is not limited to: * Responsible for QA document review of manufacturing records (Solid oral dose- tablets) * Interact with CMO colleagues to ensure that FibroGen GMP QA documentation requirements are met in advance of batch disposition * Review executed batch records, Certificates of Analysis and other technical documents to enable drug substance and drug product release certifying batches as GMP compliant * Support deviations, CAPAs and change controls related to product release and CMO operations until resolved per FibroGen SOPs and requirements * Ensure CMO deviations are communicated to appropriate FibroGen functional teams * Assist in developing, refining, and managing internal FibroGen Quality Systems * Any other duties as required by FibroGen Management Experience/Requirements: * Bachelors degree in chemistry, biology, microbiology, industrial pharmacy or other related scientific discipline with a minimum of 3 years experience in QA batch record review and lot disposition (Tablets) * Experience with drug substance and drug product review is required * Knowledge of small molecule manufacturing (solid oral dose) is required * Practical knowledge of cGMP and an ability to apply sound judgment and decision making skills (risk-based and appropriate for the phase of clinical development) in order to evaluate product release is required * Experience in review and approval of deviation, lab investigation, OOS and CAPAs is required * Experience with clinical labeling/packaging operations is desirable * Experience with QA oversight of small molecule drug substance and drug product manufacturing is a plus * Knowledge of FDA, EU, and ICH regulatory requirements and guidelines related to cGMP operations is required * Effective communication (verbal and written), interpersonal and teamwork skills is required * Ability to interact with internal and external customers (. CMOs and partners) is required * Ability to manage multiple priorities with aggressive timelines at a high level of productivity is essential FibroGen is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender identity/expression, creed, national origin/ancestry, age, alienage or citizenship, status, age, sex, sexual orientation, marital or domestic/civil partnership status, disability, veteran status, genetic information, or any other basis protected by will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance. E-Verify: Notice to all Prospective Employees Notice to Recruiters and Search Firms FibroGen makes every effort to source and hire its staff through direct recruitment methods. Employment opportunities at FibroGen are managed by our internal human resources team. Please do not contact hiring managers or other FibroGen employees. FibroGen does not accept unsolicited resumes from any source other than from the candidates themselves. FibroGen does not accept unsolicited communications from external recruiters. If there is a specific business need, a human resources team member will contact external recruiters directly. An agency or independent recruiter must have a current, signed agreement and a work order for a specific position with FibroGen before presenting candidates and must be presented to human resources. Submission of unsolicited resumes without a signed agreement and an applicable work order will not create an obligation on the part of FibroGen to pay a fee of any kind.