Senior Quality Assurance Specialist - Brea, CA

Job DescriptionATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps.Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.Nature and ScopeUnder the supervision of the Director of Quality Assurance this position is responsible for batch release for commercial product to the market. This position supports the activities and initiatives to implement and manage the Quality System.Essential Duties and ResponsibilitiesNothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.Reviews batch records and oversees the process to release batches from quality hold and provide Certificate of Conformance.Review batch release from Contract manufacturing operations (CMO) and perform final batch release to commercial market.Communicate and resolve issues with CMOs.Manage and support customer and/or regulatory audits, inspections, and the site responses.Follow up and finalize regulatory and client audit responses and ensure the completion of the CAPA.Perform site wide routine inspection readiness training.Monitor the production schedule and ensure adequate line coverage support from QA.Evaluate, analytes and trends quality key performance indicators. Develop and manage key performance indicators and metrics to present to the leadership team.Review Quality agreement and finalize Quality agreement and PV agreement with supplier, vendor, and client.Facilitate manufacturing deviations and investigations.Support FDA field Alert.Perform customer complaint investigation.Review and approve protocol and report as assigned.Support change control for operation department.Participate and support in internal/external audits.Author, review and approve Standard Operating procedures.Other quality assurance duties as assigned and required to meet relevant 21 CFR Part 210 and 211.Perform any other tasks/duties as assigned by management.Additional Qualifications/ResponsibilitiesEducation Requirements and QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.Bachelor's degree in chemistry or biology; or equivalent combination of education and experience.10+ years of related manufacturing and quality assurance in the pharmaceutical industry.Broad knowledge of scientific theories, instrumentation, and techniques.Thorough knowledge of GMPs, GLPs and pharmaceutical products.Working knowledge of all phases of pharmaceutical manufacturing and laboratory operations,Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. Physical Environment and RequirementsPhysically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.Employee must be able to occasionally lift and/or move up to 25 pounds.Expected Salary Range:$102,500-108,000