Quality Assurance (QA) Specialist
Job Description Company Description: Molecular Templates (MTEM) is a clinical stage biopharmaceutical company targeting a variety of cancers through development of its innovative proprietary Engineered Toxin Body (ETB) platform. MTEM's 1st immunotoxin, MT-3724, is in clinical development for non-Hodgkin's lymphoma. Pipeline products for additional oncology targets are being advanced toward clinical development. For more details, please visit MTEM's web siteat www.mtem.com. Position details: Molecular Templates is seeking a highly-skilled and motivated QA professional to support compliance and monitoring efforts for Quality Assurance. This Specialist primarily will focus on the Batch Record issuance, review, and completion process from assigning the batch record number to reconciliation, initial QA review of Batch Record, verifying completeness and identifying additional required deviations and documentation. This position will be required to work collaboratively and cross-functionally with the Manufacturing, Facility, QC, QA, and Supply Chain to ensure work flow and compliance standards. This position will require technical knowledge of bioprocesses, attention to detail, management skills, along with expertise to work independently, collaborate with cross-functional teams and manage competing priorities and timelines. Position duties will include: Perform evaluation of internal controls, communications, and maintenance of documentation as related to compliance of Batch Record with internal and external safety, quality, and regulatory standards Identify risk and evaluate deficiencies while working with internal departments/business units to appropriately remedy Facilitate internal training on quality assurance requirements, processes, and procedures. May perform internal audits and risk assessments Evaluate procedures for cGMP and other compliance standards Trend data to provide analysis and potential areas of concern to support production efficiencies, continuous process improvement and initiatives Requirements: BS degree, preferably in the Life Sciences or related position Min of 4 (4) years of industry background in biopharmaceutical or biotechnology regulated environment, preferably in manufacturing or quality role Comprehensive knowledge of cGMP regulation applicable to the FDA and comparable international regulatory agencies Demonstrated ability in managing quality systems Background with protein-based therapeutics, preferred Background performing Quality on the floor, preferred Superior written and oral communication expertise Excellent technical skills Excellent technical, analytical and problem-solving skills Excellent organizational, project management and multi-tasking skills Expertise to apply basic scientific knowledge and regulatory principles Expertise to manage competing priorities and timelines in a fast-paced, rapid-growth environment Expertise to work collaboratively with cross-functional teams and contractors in order to drive results and meet company objectives Expertise to function independently and exercise good judgement, as well as in a team-based environment Reporting Structure: This position has no supervisory responsibilities. This position reports to Sr. Manager, Quality Assurance. Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.
September 20 on ZipRecruiter