Specialist, QC Data Review (2nd Shift)

Austin, TX, USA
Feb 23, 2021
Lone Star Bio
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 an experienced QC Data Reviewer to join our Quality Department. This Specialist is responsible for the execution of activities for assigned tasks within quality control programs. Responsibilities include the management of the day-to-day data review and documentation and providing support for data review relating to deviations, CAPAs, and OOS. The successful data reviewer will be able to review release and stability data, trend charts of reference standards, lab equipment calibration records and log-books and other review functions as needed.

Job Responsibilities will include:
  • Review QC testing data packets to verify accuracy and completeness in a timely fashion to meet result reporting timelines for MTEM generated and Contract Testing Lab Data.
  • Develop proficient knowledge of the assays involved and be able to understand the nature of the data being reviewed.
  • Work with SMEs to resolve issues needing correction and eliminate ambiguities.
  • Support data presentation from reviewed testing for product review and stability information.
  • Inventory and manage completed data packets.

  • Bachelor's degree from accredited institution a scientific discipline, preferred
  • 2-4 years' experience in GMP laboratory environment, required
  • Experience in biopharmaceutical industry, preferred
  • Thorough knowledge of cGMP regulations, quality systems and regulatory requirements.
  • 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 or 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 not have supervisory responsibilities. This position reports to QC Manager.

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

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