QC Analyst 3
Sunrise Systems
Job Title: QC Analyst IV
ID: 26-04103
Location: Portsmouth, NH
Duration: 8 Months Position Summary:
Sunny Rajput | View email address on click.appcast.io | URL:
ID: 26-04103
Location: Portsmouth, NH
Duration: 8 Months Position Summary:
- The QC Analyst IV position will act as a team member of the Quality Control department to support the production of in-process and final product drug lots for customers. Also participate in quality testing for ongoing customer stability studies while providing on-time, high quality results to meet manufacturing demands.
- QC Analyst IV: Applies job skills and company's policies and procedures to complete a variety of tasks of increased scope. May be assigned to work on special projects. Also may provide support to others in the absence of the supervisor/manager. Works on problems of moderate scope in which analysis of situation or data requires review of identifiable factors
- Provides feedback to junior analysts. Offers guidance to co-workers with respect to compliance.
- Delegates tasks to support daily operations.
- Responsible for the state of equipment in the laboratory, working with maintenance, calibration, and vendors to ensure their activities are accomplished and the equipment is ready for next use.
- Equipment may include but is not limited to, pH/conductivity meters, Agilent and Waters HPLC systems, UPLC systems, pipettes, SoloVPE and Cary 60 spectrophotometers, PA-800 capillary electrophoresis instruments, Protein Simple iCE3/icIEF instruments, 7500 Real Time PCR systems, KingFisher Flex instruments, Sysmex CS-2500 instruments and include quality review of quality and vendor binders.
- Troubleshoot equipment and software as necessary.
- Will train for assay execution and review within the HPLC Analytical Lab and Electrophoresis lab and have ability to cross train into Immunology as applicable.
- Has the ability to get trained to run and review advanced assays as necessary.
- Identifies areas of improvement and works to implement them (i.e. 6S, document revisions, workorders, change controls).
- Communicates to other departments as appropriate (MFG, QA, MSAT, etc.) during operations and escalate issues as needed.
- Initiates and assists with investigations as required within the job functions.
- Drives audit readiness on the team with advanced regulatory knowledge. Conduct Pre-Audit walks through the laboratory space. Available to confidently and competently speak to auditors as QC SME.
- Apply Data Integrity principles in all aspects of work, in compliance with Client's DI policies, guidelines and procedures.
- Completes assigned tasks on-time and accurately, can identify needed tasks and complete without direction.
- Perform other duties as assigned
- Bachelors Degree with combination of education and years of experience will be considered
- Industry Experience, preferably in a cGMP environment (5-10 Years)
Sunny Rajput | View email address on click.appcast.io | URL:
Vacancy posted 2 days ago
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