QA Compliance Specialist

Description

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 education assistance, and other benefits.

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, to work on a variety of projects to gain increased learnings in Kymanox's service offerings and the life science industry as a whole.

Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, Philadelphia, and New Jersey.

To learn more about our company, please visit our website: Life Science Solutions Kymanox