QC Analyst III

Katalyst Healthcares & Life Sciences

Portsmouth, NH

JOB DETAILS
SKILLS
Analysis Skills, Assays, Biochemistry, Change Control, Communication Skills, Computer Systems, Corporate Policies, Corrective and Preventative Action (CAPA) Systems, Data Analysis, Data Quality, Establish Priorities, GMP (Good Manufacturing Practices), Laboratory Information Management System (LIMS), Microbiology, Microsoft Excel, Microsoft PowerPoint, Microsoft Product Family, Microsoft Word, Problem Solving Skills, Procedure Development, Product Testing, Production Support, Quality Assurance Methodology, Quality Control, Team Player, Testing, Time Management
LOCATION
Portsmouth, NH
POSTED
30+ days ago
Job Description:
The 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.
Key Accountabilities:
  • 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: TrackWise, 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

About the Company

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Katalyst Healthcares & Life Sciences