Pharmaceutical QC Analyst - 3rd Shift - Johnson & Johnson

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

• 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.

• Set up, operating, and cleaning laboratory equipment used to support production of intermediate, raw material, and finished products for Active Pharmaceutical Ingredients, raw material components, and other products as directed; complete all associated support activities in the laboratory.
• 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) and support the implementation of relevant CAPAs and monitor effectiveness of CAPAs and as needed.
• 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.
• Perform other duties as assigned by site leadership.

• 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.
• 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.
• 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.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most diversified healthcare products company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.Every day, our more than 150,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.