Jobs and Careers

(Contract) QC Specialist

Fort Lauderdale, United Statesfull_timeVerifiedPosted 29 Oct 2025

About the role

Is Kymanox the right fit for you? You want to make a difference and have an impact… You enjoy having an influence in your day-to-day work… You are motivated by working alongside a team filled with subject matter experts who will help you learn and grow… You wake up every day and do what you do … because patients deserve better. If this sounds like you, you’ve come to the right place. Responsibilities:

Directly support and provide subject matter expertise related to CMC/Pharmaceutical Development, Analytical Sciences, Quality Control, Stability, and Product/Process Scale-up related projects.
Perform project management roles for projects assigned within primary focus areas of CMC Services and Analytical Sciences.
Posess a solid understanding of Quality Control, CMC requirements for Biologics IND, BLA, and other global regulatory filings.
Author, format, and review CMC/Quality Sections of INDs, NDAs, ANDAs, BLAs for Regulatory Submission.
Demonstrated proficiency in chromatographic and electrophoretic techniques (HPLC, CE-SDS, etc) and biologics analytical control strategies.
Conduct analytical method validations, transfers, and stability studies to support product development and GMP release.
Perform release and stability testing for internally manufactured and client-provided samples in compliance with GMP/GLP standards.
Author, format, and review technical protocols and reports for method validation, method transfer, stability, technology transfer, risk management, and process qualification activities.
Support control system validation and equipment qualification efforts for commissioning in a GMP environment.
Provide quality compliance support, including deviation investigations, change control coordination, and complaint investigations.
Write and maintain SOPs, protocols, change controls, and technical reports for internal and external use.

Educational Background:

The ideal candidate will have a bachelor’s degree in engineering or science with coursework or work-related experience in GMP QC Analytical expertise.

Experience:

8 to 15 years of working in development and/or manufacturing in the pharmaceutical, biotechnology, combination product, and/or medical device sectors is required.
Demonstrated level of experience in the pharmaceutical and biotechnology sectors is required.
Familiarity with risk management tools and applications as well as data analysis tools and applications.
Understanding of FDAs 21 CFR 210/211.

Desired Aptitude and Skill Set:

Detail-oriented
Strong organizational skills and verbal/written communication skills
Highly motivated self-starter with a sense of ownership and willingness to learn
Thrive in a fast-paced, growing, and dynamic work environment
Ability to form partnerships with internal stakeholders
Seasoned soft skills (i.e., high EQ)
Technology savvy

Travel: Up to 10% travel is possible. Compensation: Pay rate is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions.

About Kymanox:

Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product 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. Kymanox encourages team members, especially new graduates, and young professionals, t