Quality Control Analytical Analyst
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Full-time
Compensation
USD50k - 70k/year
Posted about 3 years ago
Responsibilities
Cresilon, Inc is a medical device company based out of Brooklyn, NY. Our mission is to save lives. We focus on bringing new technologies to animal and human health to solve problems associated with wound healing. We have created a hemostatic technology that can instantly stop traumatic bleeding.
Our Quality Control Analytical Analyst will support Cresilon’ s microbiology and analytical chemistry efforts. To execute methods and perform activities in support of data. To perform all activities that comply with applicable requirements, under guidance of SMEs. The Quality Control Analytical Associate is a member of Cresilon’s technical team in cGMP laboratory. This individual is technical and willing to be trained in cGMP analytical methods. This individual offers Cresilon technical support involving analytical chemistry.
Responsibilities:
- Independently executes analytical methods within a GMP/GLP environment as per Cresilon’s standard operating procedures and USP/FDA/ISO/EU guidelines.
- Participate and support Environmental Monitoring (EM) program in partnership with Manufacturing and QA Operations.
- Monitor classified environments during manufacturing operations and routine modes for the presence of viable and non-viable particulates.
- Prepare and test samples from all phases of the manufacturing process to verify conformance to pre-defined acceptance criteria.
- Perform of out of specification investigations and if needed, initiate non-conformance reports.
- Summarize test data, maintain lot histories, and analyze for trends and discrepancies.
- Maintain and order lab supplies as needed, and participate in lab cleanup, under the supervision of QC management.
- Setup, troubleshoot, and maintain equipment.
- Test products for long-term stability
- Revise QC department protocols pertaining to analytical chemistry and procedures for operation, as applicable
- Perform analytical assay validation and/or verification, as well as instrument qualification.
- Assists in bringing in additional testing capabilities to the analytical lab as deemed necessary.
- Other duties may be assigned as deemed necessary by management.