At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.
Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting role located in Athens, GA!
Sign on Bonus and Relocation assistance available
The Quality Control Associate Analyst is responsible for testing and analyzing raw materials, in-process samples, and products such as chemicals and Active Pharmaceutical Ingredients (API) to determine stability, purity, chemical content, and other characteristics. They follow standardized test-methods, procedures, and work instructions, document test results, and communicate status of test results.
- Set up, operate, and clean laboratory equipment used to support production of intermediate, raw material, and finished products for API, medical device raw material components, and other products as directed; complete all associated support activities in the laboratory.
- Assure that QC laboratories run in a safe, clean, and environmentally sound manner.
- Review peer laboratory data to ensure accuracy and completeness.
- Demonstrate and develop experience on HPLC, UPLC, Karl Fischer, UV analysis, NIR, and other analytical techniques and train other laboratory personnel on these techniques.
- Develop skills to troubleshoot and perform minor maintenance, calibration, and repair of laboratory instrumentation.
- Provide input on investigations (OOS, OOT, invalid assays, and other lab-related non-conformances including investigations of audit observations) as needed.
- Support the implementation of relevant CAPAs and monitor effectiveness of CAPAs.
- Carry out duties in compliance with all state and federal regulations and guidelines including FDA, ISO, EPA, OSHA, and DEA, and adheres to all company and site policies and procedures.
- Minimum of a High School Diploma and a minimum three (3) years of experience in a Quality Control (FDA or USDA regulated environment) Laboratory -OR- minimum of a Bachelor’s degree in a Chemistry / Biochemistry / Environmental field (no Computer Science) is required.
- Experience applying mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlational techniques, sampling theory, and/or factor analysis is preferred
- Experience identifying and defining problems, collecting data, establishing facts, and making scientific-based conclusions is preferred
- Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and medical device is preferred
- Experience in Lab Operations and/or Quality processes/systems in a GMP Lab setting is preferred
- Experience working with Lab Systems or processes such as eLIMs, TrackWise, Non-conformances, and/or Change Control is preferred
- Familiarity with a variety of laboratory equipment, such as: GC, HPLC, UPLC, and/or Karl Fisher is preferred
- Requires ability and flexibility to work rotating hours of 6:00am to 4:30pm or 2:00pm to 12:30am shift including weekends; overtime (on a scheduled or emergency basis) to support shift operations
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .