Quality Assurance (QA) Specialist

Location
Austin, TX, USA
Posted
Aug 21, 2019
Ref
64194
Required Education
Bachelors Degree
Position Type
Full time
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 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.

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 work flow 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:

  • 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

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
  • Comprehensive knowledge of cGMP regulation applicable to the FDA and comparable international regulatory agencies
  • Demonstrated experience in managing quality systems
  • Experience with protein-based therapeutics, preferred
  • Experience performing Quality on the floor, preferred
  • Excellent written and verbal communication skills
  • Excellent computer skills
  • Excellent technical, analytical and problem-solving skills
  • Excellent organizational, project management and multi-tasking skills
  • Ability to apply basic scientific knowledge and regulatory principles
  • Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment
  • Ability to work collaboratively with cross-functional teams and contractors in order to drive results and meet company objectives
  • Ability 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.

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