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Quality Control Analyst

Cellipont Bioservices

This is a Contract position in Greeley, CO posted May 11, 2022.

Quality Control Analyst is responsible for working closely with the Quality Team members and Supervisor to assist in the maintenance and work of the Quality Control group at Cellipont Bioservices.

The Quality Control group functions include ensuring the quality, safety, and control of the products manufactured and processes performed at Cellipont Bioservices.

The Cellipont Bioservices facility is a GMP compliant facility that utilizes controlled clean room manufacturing of biological and regenerative medical products and Contract Manufacturing Organization services.Primary Responsibilities: Environmental Monitoring of GMP facility Enforce and support aseptic techniques and environment Perform Quality Control inspections and testing (i.e.

Endotoxin, Sterility, Mycoplasma, Cell Culture, Flow) Help implement corrective actions and quality improvements related to Quality Control areas of responsibility Record keeping, organization and archivingSupport Quality with the day-to-day management of the following: Organization of Quality Control test samples to include receipt and storage of quality testing samples Help with day-to-day control of records, Proficient in Microsoft Excel is preferred Assure that result data/files are complete, organized and reviewed in a timely manner Help trend quality test and environmental results Assist in investigations and quality control processesSecondary Responsibilities: Support Quality Staff with regulatory audits (FDA & State inspections), internal and external audits as needed.

Support production and manufacturing activities as needed as a quality representativePerform additional job-related duties as required, to include document revisions as neededRequired Skills/Abilities:Team minded individual with flexibility and dedicationDemonstrated ability to handle and prioritize multiple projects to meet deadlinesEfficient time management and organizational skillsSolid verbal communication skills with the ability to clearly apply written communicationUnderstanding of the field of cell therapy processing preferredAnalytical skills and solutions-oriented approach to problem-solvingAbility to work effectively in a fast-paced, rapidly changing environment with othersDemonstrated ability to work independently as well as part of an integrated teamPosition may require some “off-standard hours”Education and Experience:Associate degree or postsecondary certificate in related discipline required; Bachelor’s degree preferred 1-2 year(s) of experience in a quality role within a regulated cGMP laboratory environmentPrior experience within a biotech or a pharmaceutical company is preferred