QC Analyst III

Tek Wissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological expertise with world-class manufacturing and scientific insight to support the delivery of innovative medicines for a wide range of diseases. Specializing in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, and cell and gene therapy, the company provides comprehensive services across the pharmaceutical, biotech, and life sciences sectors.

It supports every stage of drug development, from early research to commercial production, and offers solutions in biologics, small molecules, and specialty ingredients. Committed to quality and innovation, the company serves as a critical partner in advancing therapeutic solutions and streamlining complex manufacturing processes, with a global presence that ensures access to scalable, flexible, and compliant technical expertise.

• The Quality Control Technical Transfer Analyst III / QC Analyst III will act as a team member of the Quality Control department to support production by contributing to the completion of the technical transfer activites.
• Also participate in quality testing for customer in-process, final product testing and stability studies when needed.
• Applies job skills and company's policies and procedures to complete a variety of tasks of increased scope.
• Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
• Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.

• Applies job skills and company's policies and procedures to complete a variety of tasks.
• Running test samples for In-Process, Lot Release and Stability studies.
• Running test samples for (but not limited to) investigations, transfers and validations.
• Reviewing assays, and training others
• Writing
  - Quality Records (Deviations, CAPA, Change Control) and Test Methods
• Projects – such as method transfers, new instruments, method qualifications
• Use of Microsoft Suites (Word, Excel, PowerPoint)
• Use of Laboratory computer systems
• Potential previous use of GMP Quality Systems such as:
  Track Wise, LIMS
• Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
• Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
• Apply Data Integrity principles in all aspects of work, in compliance with client DI policies, guidelines and procedures.
• Perform other duties as assigned.

• Associate’s Degree Microbiology, Biochemistry or Related Science Fields
• Strong experience with A280, CE-SDS, icIEF, ELISA, SoloVPE, qPCR is required
• Strong ability to speak publicly, interpret data both alone and with guidance.
• Perform assigned, complex and/or varied tasks.
• Prioritization and problem solving.
• Comprehend and follow instructions.
• Direct, control and plan tasks/projects and brainstorming
• Strong ability to communicate in both written and verbal format .
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Self-motivated team player
• Completes assignments on-time and accurately
• Displays commitment to quality and performs job functions to the best of his/her ability
• Relate to others in a team setting.
• Maintain positive attitude in a team environment.
• Timeliness in completing assigned tasks.
• Works entire assigned shift, including arriving on time

Tek Wissen® Group is an equal opportunity employer supporting workforce diversity.