Jobs and Careers

QA Compliance Specialist

Morrisville, United Statesfull_timeVerifiedPosted 7 Feb 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:

Conducts audits as Lead and Supportive Auditor.
Directly and/or indirectly performs project management roles for projects assigned within primary focus areas of Quality.
Participates in and supports a matrixed team environment with organization and detail-oriented initiatives.
Reviews and/or approves technically complex documentation to ensure compliance with relevant standards and regulations.
Completes gap assessments against industry regulations (21 CFR Parts 4, 11, 210, 211, and 820) or standards (ISO 9001, ISO 13485, ISO 17025, and ISO 14971).
Participates in inspections readiness, regulatory body inspections, or remediation efforts.
Follows policies or standard operating procedures to support internal or client projects.
Authors and reviews procedures, protocols, reports, and risk assessments related to product quality and safety.
Provides oversights for Quality Management Systems (e.g., deviations, CAPA, change control, document control, training, etc.).
Completes assigned training requirements (internal and external).
Develops and delivers training content internally and externally for quality management systems, regulatory requirements, and industry best practice.
Quality support of client audits both virtually and at KOP site.

Educational Background:

The ideal candidate will have a bachelor’s degree in a science-related or engineering discipline such as Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Chemistry, or Biology.

Experience:

3-6 years of experience in quality, development, and/or manufacturing in the pharmaceutical, biotechnology, combination products, and/or medical device sectors is required.
Demonstrated aptitude and knowledge of development and/or manufacturing in the pharmaceutical, biotechnology, combination product, and/or medical device sectors is required.
Experience in 2 or more of the following practice areas is desired: CGMP manufacturing, quality engineering, manufacturing sciences, quality assurance, regulatory affairs, clinical, and early-stage development, and late-stage process or product development for pharmaceuticals, medical devices, and/or combination products.
ASQ-CQA Preferred.

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
Adaptable to changing priorities or project tasking
Soft skills (i.e., high EQ)
Thrive in a fast-paced, growing, and dynamic work environment
Technology savvy
Open minded to unique ways of working and right-sized and phase-appropriate processes

Travel: Travel may be required, up to 10% Career Development: The position will evolve over time and more responsibilities may be added. Since Kymanox is a growing company, there are opportunities for advancement both within the currently defined role and in other functions within the organization. Compensation: Base salary is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions. Eligible for incentive program after 90 days of outstanding work. Benefits: Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing educatio