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Quality Assurance Associate/Specialist

Company: NightHawk Biosciences, Inc
Location: Morrisville
Posted on: May 15, 2022

Job Description:

Company
NightHawk Biosciences (NYSE American: NHWK) is a commercial stage company with a fully integrated ecosystem to accelerate the discovery and development of novel therapies that arm the immune system. By leveraging our proprietary platforms, we are advancing our first-in-class product portfolio with a focus on cancer and inflammatory and infectious diseases.

Position Summary
The Quality Assurance Associate/Specialist provides quality oversight for the NightHawk corporate quality systems as well as the outsourced cGMP manufacturing and GLP testing facilities. This includes but is not limited to, reviewing executed batch records, assisting with supplier qualification audits, quality system management, and inspection readiness. The position will report to the Director of Corporate Quality. Experience in a quality assurance setting and a working understanding of cGMP and GLP requirements is essential.

Key Responsibilities
- - - - - - - - -Provide QA support and quality oversight for outsourced cGMP operations for the manufacture of drug product
- - - - - - - - -Conduct reviews of executed batch records and ancillary documentation for accuracy, completeness, and compliance with approved procedures
- - - - - - - - -Review all investigations, quality events, laboratory investigations, and change controls associated with the release of the product
- - - - - - - - -Perform QA review and approval of Master Batch Records, protocols, reports, and SOPs
- - - - - - - - -Support, oversee, and maintain NightHawk Corporate Quality Management System
- - - - - - - - -Support, oversee, and maintain NightHawk Document Control System
- - - - - - - - -Support the management of the NightHawk training program
- - - - - - - - -Author, review, and approve quality documentation as necessary
- - - - - - - - -Assist in providing quality-related metrics/data to facilitate continuous improvement
- - - - - - - - -Support regulatory audits/inspections
- - - - - - - - -Provide support for vendor/supplier qualification and routine audits as necessary
- - - - - - - - -Communicate and collaborate with all subsidiaries of NightHawk Biosciences regarding the corporate Quality System requirements and quality function
- - - - - - - - -Performs other Quality related duties as directed

Education & Experience
- - - - - - - - -BA/BS degree in a life sciences field
- - - - - - - - -2+ years of quality assurance experience within the biotechnology / pharmaceutical industry
- - - - - - - - -Working knowledge of GxP regulatory requirements for US FDA and EU
- - - - - - - - -Strong cross-functional interpersonal skills and demonstrated ability to work independently, take initiative, complete tasks to deadlines
- - - - - - - - -Excellent oral and written communication and attention to detail
- - - - - - - - -Proficiency in MS Office suite, including Word, Excel, and PowerPoint
- - - - - - - - -Candidate must be able to work on-site in our Morrisville office

Physical & Travel Requirements
- - - - - - - - -Travel (outside of NightHawk office): - - - - - - - - -Prolonged periods of sitting and standing

Please apply using the link below:
https://heat-biologics.breezy.hr/p/4fa29f70ef35-quality-assurance-associate-specialist

Keywords: NightHawk Biosciences, Inc, Cary , Quality Assurance Associate/Specialist, Other , Morrisville, North Carolina

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