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QC Analyst I/II (Biotech Manufacturing)
Full Time
Portsmouth, New Hampshire, United States
Job description
Scismic is supporting the continued growth of global leader in life sciences and one of the largest healthcare manufacturing organizations in the world.
We are seeking QC Analysts (l and II) to join the team in Portsmouth, NH.
Overview/Role Purpose:
The QC Analyst will act as a team member of the Quality Control department to support production of in-process and final product drug lots for customers. Also participate in quality testing for ongoing customer stability studies. Provide on-time, high quality results to meet Manufacturing demands.
A QC Analyst: Applies job skills and company's policies and procedures to complete a variety of tasks. 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 and Duties:
- Running test samples for In-Process, Lot Release and Stability studies
- Reviewing assays
- Training others
- Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods
- Perform other duties as assigned
Minimum Required Qualifications/Skills:
- AA, BS, or MS - Preferred area of study in Microbiology, Biochemistry or Related Science field
- Use of Microsoft Suites (Word, Excel, Powerpoint)
- Use of Laboratory computer systems
- Strong communication skills, including public speaking
- Ability to interpret data
Qualifications for level II consideration:
- 2-4+ years industry experience, preferably in a cGMP environment
- Previous use of GMP Quality Systems such as: TrackWise, LIMS
Job Expectations:
- Perform assigned, complex and/or varied tasks with guidance from Supervisor
- Prioritization and problem solving
- Comprehend and follow instructions
- Direct, control and plan tasks/projects
- Brainstorming
- Able 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