QC Data Reviewer (Contract)

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:

Follow Quality Control procedures and other technical documents to ensure generated data is aligned with federal regulations, internal policies, and industry practice.
Provide support in quality system events such as deviations, CAPAs, and change controls.
Prepare, review, and maintain laboratory records.
Support laboratory activities for non-GMP and GMP testing of combination products and medical devices.
Participates in and supports a matrixed team environment with organization and detail-oriented initiatives.
Provides immediate project support.
Authors and reviews technically complex documentation to ensure compliance with relevant standards and regulations.
Follows policies or standard operating procedures to support internal or client projects.
Completes assigned training requirements (internal and external).
Assists in the planning and execution of lab services-related activities.

Educational Background:

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

Experience:

2+ years’ experience in the pharmaceutical or biopharmaceutical industry (this includes post graduate experience).
Demonstrated level of aptitude and knowledge in the pharmaceutical, biotechnology, combination product, and/or medical device sectors is required.
Experience with pre-filled syringes, autoinjectors, co-packaged kits, other drug delivery platforms, and/or other combination product platforms is recommended.
Experience with MS Office products (Outlook, Excel, PowerPoint, Word) strongly preferred.
Familiarity with CGMP and experience in a laboratory setting.

Preferred Qualifications

Familiarity with medical device/combination product testing
Experience working within a quality system
Familiarity with deviation and non-conformance investigations
Demonstrated work ethic and accountability
Thrive in a fast paced, growing, and dynamic work environment

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.

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

Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.

By Kymanox

Kymanox is a premier one-stop solutions provider supporting the commercialization of vital medicines and treatments for people to live better and longer. Kymanox operates in the Biotechnology, Pharmaceutical, and Medical Device, and Combination Pr...

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FUNDING

Growth

DEPARTMENTS

Quality Assurance

SENIORITY LEVEL REQUIREMENT

Mid-Level

INDUSTRY

Health Care

TEAM SIZE