Quality Specialist - QMS

Morrisville, North Carolina, United States | Erica Fadool/Laura Weeks | Full-time | Partially remote

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Kymanox is seeking a Quality Specialist to join the QA and Compliance department. The Specialist will work alongside experts in Manufacturing Quality, Compliance, Quality Systems, and Quality Technical Servies to support Kymanox projects which provide professional services for its Biomedical, Pharmaceutical and Medical Device Clients.

The Specialist will support clients in the various service offerings across quality, regulatory, and compliance. The Specialist will have the opportunity to develop his or her skillset within quality systems, manufacturing quality, investigational services, and compliance and auditing.

Job Description:

  • Directly support and provide subject matter expertise related to all disciplines of Quality including, but not limited to, Quality Control, Quality Assurance/Compliance, Quality Management Systems related projects
  • Directly and/or indirectly perform project management roles for projects assigned within primary focus areas of Quality
  • Author, Format, and Review procedures, methods, manufacturing records, sampling plans, specifications, technical protocols and reports, risk assessments and other technical documents in accordance with federal regulations, internal policies, and industry best practice 
  • Experience with analytical method validation, method transfer, process validation, and equipment qualification
  • Provide quality oversight and subject matter expertise of Quality related change controls, deviation product impact assessments, Out of Specification (OOS), Out of Trend (OOT), CAPAs, non-conformances, supplier management, product complaints, and adverse events
  • Assist in the interpretation and implementation of compendial changes to maintain current practice with USP, EP, and JP pharmacopeias
  • Compile and review information to regulatory submissions, inspections or response letters to regulatory bodies
  • Deliver training related to Current Good Manufacturing Practices, Data Integrity, Good Documentation Practices, Good Clinical Practices, Good Distribution Practices, or similar topics
  • Provide regular updates to functional area-management, to facilitate timely decision-making and prioritization of project activities and deliverables.
  • Support auditing and gap assessments against industry regulations or standards for component suppliers, manufacturers, laboratories, clinical sites, and distributors through audit scribing, auditing, report authoring, and correspondence with suppliers/auditees

Desired Aptitude and Skill Set:

  • Flexible and versatile
  • Highly organized
  • Resourceful
  • Self-directing, self-pacing, fast learner
  • Excellent written and oral English communication and presentation skills
  • High energy level
  • Appreciation for variety
  • Excellent problem-solving skills
  • Seasoned soft skills (i.e., high EQ)
  • Thrive in a fast-paced, growing, and dynamic work environment

Required Educational Background:

Bachelor of Science in Science-related discipline or Engineering (Chemical, Biomedical, or a related discipline, etc.) from an accredited institution. Advanced degree or industry certifications (e.g., ASQ, ISO) preferred, but not required. 

Required Experience:

  • 5-10 years of experience in the pharmaceutical/drug, biotech/biologics, cell/gene therapy, and/or medical device sectors is essential.
  • Possesses a diverse background relating to pharmaceutical, biologics or gene/cell therapy development, and/or drug/device combo development, including direct working knowledge of Quality Control, Quality Assurance and/or Quality Enterprise systems.
  • Direct experience with, and application of, project management concepts and tools.
  • Direct knowledge of statistical analysis and related tools and programs.
  • Possesses the ability to drive program and project initiatives from the concept phase to full implementation.
  • Possesses a strong business acumen and ability to engage, build, and maintain strong client relationships.
  • Possesses experience with Electronic Document Management Systems (EDMS) and electronic Quality Management Systems (eQMS). 

Estimated Travel:

Local travel within the assigned region and surrounding areas is required. Up to 30% remote travel may be required from time-to-time.

Region(s):

Research Triangle Park, NC Area preferred

Remote acceptable

About Kymanox:

Join Kymanox and tangibly help the world produce modern medicine more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, and medical device industries. With a reputation of providing unparalleled professional services, and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement.