Quality Assurance (QA) Manager
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 first 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 information, please visit MTEM's website at www.mtem.com.
Molecular Templates is seeking a highly-skilled and highly-motivated professional to lead quality assurance efforts. The Quality Assurance (QA) Manager will primarily manage the development, implementation and maintenance of quality assurance systems and activities to meet 21 CFR Part 211 compliance. This position will manage document control, supplier management, batch record review and release, deviations and nonconformities, corrective and preventative actions. This position will also conduct internal audits, out of specification laboratory investigations and method, equipment and process validations, plus lead in identifying continuous process improvement areas, compliance with GMP processes and documentation and other training for quality activities with a high degree of accuracy and efficiency. This requires excellent technical skills and abilities, analytical and mathematical skills, organizational and time-management skills, verbal and written communication skills, plus ability to apply attention to detail.
Job Responsibilities will include:
- Manage and develop a Quality system to meet 21 CFR Part 211 compliance.
- Oversee and manage systems to support:
- Provide document control, including but not limited to: issuance of all QA assigned numbers, creation and issuance of logbooks, routing and tracking of new and revised documents for approval, filing of controlled documents and other documentation provided to QA, and ensuring that all documents follow the change control procedure.
- Support manufacturing activities, including but not limited to: batch record review and release, nonconformities, supplier qualification, technology transfer, scale-up, validation, training and other GMP activities.
- Conduct internal audits, including but not limited to: execution of assigned internal audits, identifying and implementing corrective and preventative actions, such as authoring of observations, coordinating with audited department personnel on corrective actions to be effectively implemented, and finalization and close out of audit reports.
- Lead method, computer, equipment, and process validations, including but not limited to: review and approval of in-process testing, release testing of products, stability testing, other data summaries, method validation data, laboratory equipment validation protocols, product certificates of analysis, and out of specification/laboratory investigations.
- Complete additional projects, for example process improvements, spreadsheet validation, or implementation of new instrumentation
- Bachelor's degree from accredited institution in life science, chemistry, pharmaceutical science or related field
- Minimum of seven (7) years of related professional experience in laboratory setting, with at least four (4) years QA management role, specifically leading quality systems.
- Experience in biopharmaceutical industry, required
- Experience in GMP manufacturing environment, analytical methods and optimization, maintaining mammalian cell lines using aseptic technique, conducting analytical protein assays such as SDS-PAGE, CGE, and SE-HPLC, preferred
- Significant and demonstrated knowledge of laboratory equipment, product use, and terminology
- Excellent problem-solving and analytical skills applied to investigations
- Excellent project management, time management, and multi-tasking skills
- Excellent written and verbal communication skills
- Excellent computer skills with knowledge of spreadsheet, word processing and statistical analysis software
- Ability to manage competing priorities and projects
- Ability to function independently and exercise good judgement
- Ability to identify problems and solutions then take action to resolve
- Demonstrated ability to resolve operational and strategic issues
- Ability to understand instructions and to learn how to maintain equipment
- Ability to apply attention to detail as applied to data review and compliance
- High degree of reliability and professionalism
This position currently has no supervisory responsibilities. This position reports to Sr. Director of Quality.
Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.