Quality Assurance Specialist II
Technekes
 Durham, NC

CoImmune Inc. is a US company based in Durham North Carolina that was founded in 2019 based on its expertise in the development and manufacture of cell-based therapeutics to treat unmet medical needs including cancer, autoimmune and inflammatory diseases. CoImmune has a 20,000 sq. ft. cGMP manufacturing facility capable of supporting clinical studies from Phase I through Phase 3. The company is preparing to initiate its first Phase 2 clinical trial using a strategic combination of immune-oncology therapeutics. In addition to developing its own therapeutic pipeline, the company plans to use its excess cGMP manufacturing capacity to provide revenue-generating contract services for the manufacturing of third-party clinical stage cell-based products.

SCOPE: This individual will utilize developed, internal quality systems, procedures, and practices to support manufacturing of a cellular based product in a cGMP compliant environment. This position will also assist in the development of new systems and maintenance of existing systems.

RESPONSIBILITIES:

  • 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 executed batch records and participate in the disposition of Clinical Trials Materials (CTMs) including review of all associated documentation and transfer of materials from manufacturing to QA
  • Assist with issuance, review and archiving of controlled documents as needed
  • Provide QA review and release of incoming raw materials (including blood products) and serve as a resource in resolving discrepancies
  • 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
  • Assist with internal and external audits, as required
  • Participate in the initiation, receipt, and review of Vendor Surveys
  • Other duties as required

QUALIFICATIONS:

  • Prefer Bachelors or Masters degree in a scientific discipline or equivalent
  • A minimum of three years industrial cGMP experience in an FDA regulated Biopharmaceutical environment with 2+ years QA experience
  • Strong writing and verbal communication skills
  • Strong computer skills (Word, Excel, PowerPoint, etc.)
  • Must have experience auditing to cGMP standards and 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
  • Willingness to travel for external audits (< 10%)

PHYSICAL DEMANDS:

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.