Document Control Associate
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 an experienced and highly-motivated professional to support quality assurance activities. The Document Control Associate will be responsible for the administration of controlled document system, variance system, issuance of batch records and maintenance of quality files. This role must be conscientious of compliance with internal and external safety, quality, and regulatory standards in accordance with 21 CFR Part 211 and internal controls. 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:
- Conduct 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 variance system related to manufacturing activities, including batch record review and release
- Assist in management of variance system, such as deviations, out of specifications and other non-conformities
- Complete additional projects, for example process improvements, spreadsheet validation, or implementation of new instrumentation, as needed
- Bachelor's degree from accredited institution in life science, chemistry, pharmaceutical science or related field
- Minimum of one (1) year in QA support role
- Experience in biopharmaceutical industry, required
- Experience in GMP manufacturing environment, preferred
- Significant and demonstrated knowledge of laboratory equipment, product use, and terminology
- Excellent problem-solving and analytical skills applied to investigations
- Excellent organizational, 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 follow written and verbal instruction and work under minimal supervision
- Ability to manage competing priorities and projects
- Ability to apply attention to detail as applied to data review and compliance
- Ability to work in a fast-paced, high-growth team environment
- Ability to lift 30 lbs. and must be able to stand, crouch, sit, bend, or stretch for extended periods of time
- Must possess high degree of reliability and professionalism
This position currently has no supervisory responsibilities. This position reports to Sr. Director, 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.