Document Control Supervisor, Quality Assurance

Location:

Austin, TX

Company Description:

Molecular Templates is a clinical stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics for cancer. We believe our proprietary biologic drug platform technology, referred to as engineered toxin bodies, or ETBs, provides a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics. ETBs utilize a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional information about Molecular Templates can be obtained at www.mtem.com.

Position Overview:

Molecular Templates is seeking a highly skilled and highly-motivated professional to lead quality assurance document control efforts. The Document Control Supervisor will primarily support the implementation and maintenance of Document Control system and activities to meet 21 CFR Part 211 compliance. The Document Control Supervisor primary responsibilities include coordinating Document Control personnel and activities, related to the identification, collection, distribution and filing of controlled documents. Key contributions of the role will include writing, revising, and maintaining document control procedures as well as participation in the development and deployment of document control tools.

Job Responsibilities will include:

• Accountability for MTEM Document Control System including but not limited to:
  • Providing direct supervision to Document Control team members
  • Promoting a team environment through training, mentoring, and motivating to achieve departmental daily requirements
  • Schedules and plans work assignments for department
• Ensures timely issuance of controlled documents such as Standard Operating Procedures and Forms, Manufacturing Records, and Quality Control Records
• Writes and maintains document control procedures
• Develops and delivers training regarding document control processes and system changes
• Provides support and guidance for the development and maintenance of site documentation, procedures, and templates
• Maintains the document storage room, and manages off-site archiving of documents
• Executes the process for identifying, collecting, distributing, and filing controlled documents
• Ensures the released documentation supporting GMP operations is processed in a timely manner to meet site timelines
• Creates and approves document change requests, manages document workflows, and releases documents to an effective state
• Supports internal and external audits and regulatory inspections
• Collaborates with and supports Quality, Manufacturing, Supply Chain and Facilities departments on cross functional projects
• Performs routine and ad hoc Document Control metric reporting and analysis
• Provides communication of the status of deliverables to customers, management, and stakeholders

Qualifications:

• Bachelor's degree from accredited institution in life science, chemistry, pharmaceutical science or related field. Advanced Degree, preferred
• Minimum of five (5) years of document control experience in Quality with at least two (2) years' experience in supervising people
• Experience in biopharmaceutical, pharmaceutical, or medical device industry, required
• Demonstrated knowledge of cGMP regulations, 21 CFR Part 211, quality systems, and regulatory requirements
• Experience working with eQMS systems a plus
• 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 MS Office products including spreadsheets and word processing
• Ability to manage competing priorities and projects
• Ability to function independently, exercise good judgement and work in a team-based environment
• Ability to identify problems and solutions then act to resolve
• Demonstrated ability to resolve operational and strategic issues
• Ability to apply attention to detail as applied to data review and compliance
• High degree of reliability and professionalism

Reporting Structure:

This position will have supervisory responsibilities. This position reports to Manager, Quality Assurance.

Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.

Molecular Templates Inc https://mtem.isolvedhire.com