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Quality Control Manager (CV-12)

Covid 19 Search Partners

This is a Contract position in Suffolk County, NY posted June 15, 2020.

Covaxx, a subsidiary of the UBI Group, has joined the fight against COVID-19 and is rapidly developing precision antibody-based assays and vaccine candidates needed to successfully manage and slow the rate of the outbreak.

As a result, Covaxx is quickly expanding to meet aggressive development and production goals, and is seeking to immediately hire a Quality Control Manager with responsibility for the supervision of the Quality Control Laboratory, including assuring that all testing is performed under accordance with UBI and Federal regulations for the manufacturing of a safe, pure, potent, effective, quality product.

Responsibilities include, but not limited to: Schedule and prioritize all laboratory activities Responsible for the training, supervision and evaluation of all laboratory technologists.

Review all testing records for accuracy and completeness within the QC department Responsible for initial disposition of all manufactured products Analyze and conclude on stability data Create, edit, and maintain all laboratory related SOPs Review all data collected annually and conclude results.

Determine frequency of testing algorithm for QC procedures.

Define specifications of existing methods and/or new methods in accordance with cGMP regulation Interact with Production, Material Control, Purchasing, Engineering, Shipping/Receiving on a routine basis to allow for smooth operational scheduling Initiates non-conforming materials report, and initiates investigation of discrepancy Reviews and improves efficiency of the laboratory Bring in new technologies which may improve quality and efficiency of test results Review systems in the laboratory to reduce costs Design experiments as needed Develop validation protocols, methods development/validation protocols.

Report on results and define frequency and criteria of re-validation.

Qualifications: B.S./B.A.

in Biology/Chemistry or related Life Sciences with five to ten years supervisory experience in a QC laboratory.

Or, M.S.

in Biology/Chemistry or related Life Sciences with two to five years supervisory experience in a QC laboratory Knowledge of cGMPs, 21 CFR 211 (pharmaceuticals), 21 CFR 600 (biologics), USP/NF, EPA, OSHA regulations required Proficient in writing and communication skills Knowledge of statistics Experience in sterile manufacturing of parenterals Work Setting: All candidates must be willing to work on a full-time basis at Covaxx’s headquarters in Hauppauge, New York.

Confidentiality: By submitting your resume through this posting, you are authorizing the review of your resume, including name and contact information, solely by Covaxx, Inc.

and/or its authorized representative as a prospective candidate for the position described.

Your submission will be deemed strictly confidential, and in no circumstance will your personal information be provided to any other individual or company without your written consent.

For further information go to: covid19searchpartners.com .

Long Island, Nassau County, Brooklyn, Queens, Brookhaven, Medford, Smithtown