QC Analyst III

  • Contract

Company Description

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

 

Job Description

Job Description:

Quality Control Technical Transfer Analyst 3 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.

Roles & Responsibilities

  • 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.
  • 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 Lonza DI policies, guidelines and procedures.
  • Perform other duties as assigned.
  • Associate's degree Microbiology, Biochemistry or Related Science Fields.
  • Strong ability to speak publicly.
  • Strong ability to 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.
  • 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.

Additional Information

All your information will be kept confidential according to EEO guidelines.