Associate Analyst, Quality Control

Janssen Pharmaceuticals, Inc, is hiring for a Quality Control Associate Analyst at our Athens, GA location!

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.

Benefits you will enjoy starting your first day:

• Full medical, dental and vision coverage, a competitive 401k match, HSA/FSA, and company paid Pension plan.
• Tuition Reimbursement for eligible degree programs.
• Competitive pay based on experience, plus an annual performance bonus.
• Relocation assistance for candidates outside the 50-mile radius of Athens, GA.
• 120 hours paid vacation, plus 40 hours paid sick leave and an additional 40 hours paid personal leave.

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!

As a Quality Control Associate Analyst, you will:

Administer the testing and analyzing of 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.

In this position you will be responsible for:

• Set up, operating, and cleaning 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.
• Provide input on investigations (OOS, OOT, invalid assays, and other lab-related non-conformances including investigations of audit observations) and support the implementation of relevant CAPAs and monitor effectiveness of CAPAs and as needed.
• Review peer laboratory data to ensure accuracy and completeness.
• Perform other duties as assigned by site leadership.
• Develop skills to troubleshoot and perform minor maintenance, calibration, and repair of laboratory instrumentation.
• Demonstrate and develop experience on HPLC, UPLC, Karl Fischer, UV analysis, NIR, and other analytical techniques and train other laboratory personnel on these techniques.
• Carry out duties in a safe manner and within compliance with all state and federal regulations and guidelines including FDA, ISO, EPA, OSHA, and DEA, while adhering to all company and site policies and procedures.

Qualifications

Qualifications:

• Experience identifying and defining problems, collecting data, establishing facts, and making scientific-based conclusions is preferred.
• 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 working with Lab Systems or processes such as eLIMs, TrackWise, Non-conformances, and/or Change Control is preferred.
• Experience in Lab Operations and/or Quality processes/systems in a GMP Lab setting is preferred.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and medical device is preferred.
• Availability to work rotating hours of 6:00am to 4:30pm and 2:00pm to 12:30am shifts including weekends; overtime (on a scheduled or emergency basis) to support shift operations required.
• A High School Diploma with 3+ years of experience in a Quality Control Laboratory (FDA or USDA regulated environment) -OR- a Bachelor’s degree with 0+ years’ experience in a Chemistry / Biochemistry / Environmental field (no Computer Science) is required.
• Familiarity with a variety of laboratory equipment, such as: GC, HPLC, UPLC, and/or Karl Fisher is preferred.

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 .