QC Analyst II/III (Biotech Manufacturing) Night Shift
Full Time
Portsmouth, New Hampshire, United States (This job is on-site)
Job description
Scismic is supporting the continued growth of the global leader in life sciences and one of the largest healthcare manufacturing organizations in the world.
We are seeking Quality Control (QC) Analyst II/III (Night Shift) to join 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 III: 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.
10 Hour Night Shifts Either:
- Sunday - Wednesday: 8:00 pm to 6:30 am or
- Wednesday - Saturday: 8:00 pm to 6:30 am
Key Responsibilities:
- 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.
- Projects – such as method transfers, new instruments, method qualifications.
- Perform other duties as assigned.
Key Requirements:
- Bachelor’s or Associate’s Degree. Preferred area of study in Microbiology, Biochemistry or Related Science Fields.
- 2-5+ years industry experience, preferably in a cGMP environment.
- Use of Microsoft Suites (Word, Excel, Powerpoint).
- Use of Laboratory computer systems.
- Potential previous use of GMP Quality Systems such as: TrackWise, LIMS.
- Excellent ability to speak publicly.
- Excellent ability to interpret data.
- Perform assigned, complex and/or varied tasks. Make basic quality decisions independently.
- Begin to mentor other analysts.
- Prioritization and problem solving.
- Comprehend and follow instructions. Be able to communicate instructions to others in a clear, concise manner.
- Direct, control and plan tasks/projects.
- Brainstorming.
- Excellent ability to communicate in both written and verbal format.
- Relate to others in a team setting.
- Maintain a positive attitude in a team environment.
- Act as an example of professionalism to other Level 1 and 2 analysts.
- Timeliness in completing assigned tasks.
- Works the entire assigned shift, including arriving and departing on time.
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