QA Associate II

Company: Cortech
Location: Fremont
Posted on: January 13, 2021

Job Description:

DutiesResponsible for executing QA operations and overseeing junior team members as they assess,evaluate, and review operations on the floor (as defined above) against cGMPs to assure realtimeobservation of activities, issue identification/ resolution including proper and timelydocumentation. Provides guidance to MFG, E&T, and/or QC to ensure compliance with allapplicable regulations and assists in resolution of issues identified. Information must be proactivelyshared across QA and the business including the on-going training of junior teammembers.--- Identifies, classifies and reports deviations, as appropriate and typically works on more complexMinor and/or Major deviations. Oversees execution of remediation/CAPA activities required tocontinue production or move a process to the next milestone. Works closely with others todetermine root cause and potential preventative/corrective actions. Ensures support for the timelyclosure of investigations.--- Authorized to suspend any operation when the situation warrants. Provides guidance and controldirectives regarding remediation activities required to continue production. Is required to resolvecritical issues within area assigned and may escalate to senior management team based onseverity of the issue.--- Responsible for providing quality oversight to the change management system for complex Minorand/or Major classified Change Controls. This includes providing plan creation oversight,verifying that changes adhere to local SOPs and regulatory compliance and ensuringcommunication/escalation of potential issues of broader impact to the business.--- Performs independent technical review of documentation during and post-execution of cGMPactivities. Has authority to sign off/qualify/train junior staff on QA Operation responsibilities.Ensures all specifications are met and that applicable requirements are completed andacceptable. Ensures all issues/documentation associated with each process in assigned areahave been resolved and approved prior to release to the next step and are compliant with cGMPsand SOPs and current manufacturing regulations and site procedures. Analyzes and reportsfindings to appropriate departments.--- Works closely with others in the assigned area to recognize opportunities for improvement anddrive change through the use of BIFI's Quality Systems. May be asked to become a certifiedGreen-Belt and be assigned to lead process improvement initiatives via the BPE program. Mayalso attend, as a QA project team member to provide QA guidance and oversight to suchimprovements.--- Will serve as Subject Matter Expert for internal or external matters. Participates in inspectionreadiness activities and significantly involved in inspections by regulatory agencies.--- Creates and establishes processes and procedures to ensure compliance and adherence toregulated QA activities for cGMP operations.SkillsStrong independent judgment and decision making abilities required.--- Strong knowledge of relevant regulatory guidances.--- Demonstrated problem-detection and problem-resolution skills required.--- Strong conflict resolution and negotiation skills required.--- Must possess demonstrated organizational skills that have proven results in the ability to be selfdirectedwhile managing multiple projects.--- Must possess excellent verbal and written communication skills; good interpersonal skills.--- Capability to establish good relationships with others who have different values, cultural stylesand perspectives.--- Setting high and ambitious goals and standards for oneself and others, continuously raises thebar.EducationRequires a Bachelor's Degree from an accredited institution preferably in sciences plus minimumof three (3) years of experience working in the Quality related aspects of a life sciences or closelyrelated industry.--- In lieu of a Bachelor's Degree, a High School Diploma plus seven (7) years of experience workingin the Quality related aspects of a life sciences or closely related industry will be considered.

Keywords: Cortech, Fremont , QA Associate II, Other , Fremont, California