Specialist, Quality Assurance (Systems)

Location
Austin, TX, USA
Posted
Aug 19, 2020
Ref
175054
Required Education
Bachelors Degree
Position Type
Full time
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 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 workflow and compliance standards. This position will require technical knowledge of bioprocesses, attention to detail, organizational skills, along with ability to operate independently, collaborate with cross-functional teams and manage competing priorities and timelines.

Job Responsibilities will include:
  • Provides QA support for deviations, laboratory investigations, corrective and preventive actions, and change controls
  • Provides QA review for qualifications and validations of equipment, methods, and processes
  • 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
  • Prepare and deliver communications with interpretation of data analysis and potential problems to management
  • Provides support in the review of change controls related to manufacturing, test methods and specifications to meet cGMP and internal standards
  • Collaborate is cross-functional work groups on organization initiatives
  • Write and review Standard Operating Procedures as needed

Qualifications:
  • BS degree, preferably in the Life Sciences or related field
  • Minimum of four (4) years of industry experience in biopharmaceutical or biotechnology regulated environment, preferably in manufacturing or quality role
  • Knowledge and experience with cGMP manufacturing, quality, and compliance
  • Skilled in data analysis and problem solving
  • Must be action-oriented and customer-focused and skilled in building relationships, problem solving, planning and organizing and analytical thinking
  • Ability to complete tasks with minimal supervision
  • Demonstrated ability to recognize Quality issues and takes on role as problem solver
  • Skill in providing input within the department and in cross functional teams
  • Ability to write and review reports with clarity and brevity
  • Demonstrated competence in quality processes, including change control, deviations and CAPA management
  • Excellent verbal and written communication skills
  • Ability to multitask in a fast-paced environment
  • Possesses strong authorship and ability to critically review investigations, interpret results and generate technical conclusions.

Reporting Structure:

This position has no 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