Quality Control Scientist III

Velocity Bioworks•San Antonio, TX

9h•Onsite

About The Position

Reporting directly to the Manager, Quality Control, the Quality Control Scientist III, demonstrates full understanding of scientific and technical aspects of biological Drug Product/Drug Substance (DP/DS), as well as technology transfer, assay qualifications and validations activities. The Quality Control Scientist III is responsible for performing routine, In-process, and stability testing of drug products and analysis of raw materials, intermediates, and finished products, utilizing various analytical techniques and methods. This job might be for you if you enjoy working in a fast-paced environment and you have the skills to balance multiple tasks, prioritize them, and complete them independently while excelling at keeping all impacted parties well-advised. An ideal candidate must have strict attention to detail, high-quality customer service skills, and the ability to work well and collaborate in cross-functional teams at Velocity Bioworks.

Requirements

Bachelor or advanced Graduate degree (MS/PhD) in Chemistry, Biological Sciences Microbiology, Biochemistry or equivalent field.
4+ years of relevant experience or equivalent for Bachelors’ or 3+ years of relevant experience or equivalent for Masters or PhD with 1+ year in QC operations
Candidate should be familiar with analytical and QC operations in the pharmaceutical industry and understand key regulations and trends in biologics development and manufacturing, including CGMP, FDA, ICH, USP, EMA, and global compendia guidance.
Working experience in quality control operation to support clinical and commercial scale manufacturing, product testing, and regulatory IND/BLA filing.
Strong technical and scientific knowledge of general QC testing.
Hands-on experience in modern analytical instruments and methods, such as HPLC, UPLC, CE, iCE, ELISA, qPCR, pH, Appearance, Osmolality, Total Organic Content, Endotoxin, Western Blotting, LC-MS/MS and Cell-based Bioassays.
Ability to evaluate technical data
Working experience with performing industry investigations/deviations.
Working experience with analytical method qualification and validations.
Working experience with training analysts on new transfer methods.
Experience with lab-based software systems such as: LIMS/ELN, Empower, including validation of templates within these systems.
Excellent communication skills with the ability to collaborate across multiple teams and projects.
Experience with speaking publicly.
Able to maintain control of meetings as required.

Responsibilities

Conduct assays and lab procedures according to and in compliance with CGMP guidelines and internal SOPs.
Performing routine, In-process and stability testing analysis of raw materials, intermediates, and finished products, utilizing various analytical techniques and methods.
Ensure testing is completed in compliance with all applicable procedures, standards, and CGMP regulations.
Work with Analytical Development team, Quality and Operations organization to successfully transfer process/analytical testing to the CGMP facility to manufacture products.
Ensure all analytical data from the laboratory is accurate, precise, robust and is generated following methods, specifications, and procedures.
Ensure compliance with training, testing, documentation, and general lab maintenance requirements for industry standards and/or regulations.
Perform tasks in a manner consistent with the safety policies, quality systems and CGMP requirements.
Investigate Out-of-Specification (OOS) results and laboratory deviations, conduct root cause analysis, and implement CAPA.
Ensure successful method transfer, including training of personnel for execution and review, review of data, and completion of documentation.
Responsible for ensuring all QC laboratory equipment is maintained and calibrated according to schedule.
Shifts may include routine weekend and evening work as required by the manufacturing process.
Train junior staff on new methods of tech transfers.