Job: Quality Assurance Specialist, CoImmune, Inc., Durham, NC
Quality Assurance Specialist
Durham, NC 27704 United States
4233 Technology Drive
CoImmnune offers a competitive salary and benefits package to include Medical Insurance, Dental and Vision Insurance, FSA's, Short and Long Term Care benefits, PTO, and 401-K plans.
SCOPE: This individual will utilize developed, internal quality systems, procedures, and practices for support of cGMP manufacturing of cellular based products in a cGMP compliant environment. This position will assist in maintaining and improving existing systems while supporting development of new policies and procedures.
-Provide QA review of GMP documentation, including Item Specifications, SOPs, production records and test methods along with validation protocols and reports
-Author or revise SOPs and item specifications
-Initiate and approve Quality System documents including deviations, CAPAs, Change Requests and non-conforming reports
-Review of executed batch records and participation in the disposition of Clinical Trials Materials (CTMs) including review of all associated documentation, transfer of materials from manufacturing to QA, and shipment of materials to clinical sites
-Assist with issuance, review and archiving of controlled documents as needed
-Provide QA review and release of incoming raw materials (including blood products) and consumables
-Provide QA review and oversight for product shipments
-Work on problems of moderate scope in which analysis of the situation or data requires a review of identifiable factors, such as those exhibited in Deviation Reports
-Review QC results, as needed
-Train for sterile gowning to observe manufacturing processes, as needed
-Other duties as required
-Prefer bachelor’s or master’s degree in a scientific discipline or equivalent
-A minimum of two years industrial cGMP experience in an FDA regulated Biopharmaceutical environment with 1+ years QA experience preferred
-Strong writing and verbal communication skills
-Strong computer skills (Master Control experience preferred)
-Must have experience auditing to cGMP standards along with writing and maintaining controlled documents
-Strong interpersonal communication skills
-Demonstrated initiative and attention to detail
-Demonstrated ability to multitask and meet deadlines
-Ability and willingness to be regularly, predictably and reliably at work
Work is a mixture of sedentary and physical. Standing, with some occasional physical demands such as with pushing, pulling and lifting is required. Some work will require working with ultra-cold materials for a short amount of time while wearing personal protective equipment.
The requirements listed in this job description are representative of the management’s assignment of essential function, with knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Nothing in this herein restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Furthermore, the job description doesn’t constitute a contract of employment and CoImmune Inc. may exercise its employment-at-will at any time.
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