Analyst , Lab Quality Control

At Johnson & J&N, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Quality

Quality Control

Professional

Athens, Georgia, United States of America

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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We are searching for the best talent for an Analyst 1, Lab Quality Control to be in Athens, GA
.

• Competitive pay based on experience, night shift differential, plus an annual performance bonus.
• Full medical, dental and vision coverage, competitive 401k, 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.

The 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 adhere to all company and site policies and procedures.

• Requires ability and flexibility to work weekends and overtime (on a scheduled or emergency basis) to support shift operations.
• High school diploma or two-year technical degree in a science or laboratory related field with four (4) years of Experience in a Quality Control (GMP regulated) Laboratory.
• OR Bachelor’s or Master’s degree in Chemistry or related science degree.

• 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.
• Experience identifying and defining problems, collecting data, establishing facts, and making scientific-based conclusions.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and medical device.
• Experience in Lab Operations and/or Quality processes/systems in a GMP Lab setting.
• Experience working with Lab Systems or processes such as eLIMs, Track Wise, Non-conformances, and/or Change Control.
• Familiarity with a…