Analyst 1, Laboratory Quality Control (3rd Shift) - 2306156140W

　　Description

　　anssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an

　　Analyst 1, Laboratory Quality Control located in Athens, Georgia.

　　At Janssen, we never stop working toward a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension. Visit us: www.janssen.com

　　Essential Job Duties and Responsibilities

　　Set up, operate and clean laboratory equipment used to support production of intermediate orfinished products for Active Pharmaceutical Ingredients, medical device raw material components,

　　or 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.

　　Tests and analyzes raw materials, in-process samples and products such as chemicals and Active

　　Pharmaceutical Ingredients to determine stability, purity, chemical content, and other

　　characteristics. Follows standardized formulas or experimental procedures. Documents test results.

　　Communicates status of test results.

　　Reviews peer laboratory data to ensure accuracy and completeness.

　　Develop skill set on HPLC, UPLC, Karl Fischer, UV analysis, NIR, and other analytical techniques and

　　train laboratory personnel on these techniques.

　　Maintain sample control of all samples submitted to the laboratory.

　　Develop skills to troubleshoot and perform minor maintenance, calibration and repair of laboratory

　　instrumentation.

　　Prepare or handle chemicals associated with laboratory activities, including Buffer Solution pH, 90%Alcohol, Hydrochloric Acid, Sodium Hydroxide, Sodium Phosphate, Sodium Chloride, Nitrogen, and

　　assorted polymers. Monitor inventories of chemicals and supplies to ensure continuity of

　　consumables supply for testing.

　　Input of QC data to information systems: e.g.: ERP, databases, planning database, etc.

　　Identify opportunities for improvement to efficiency and reliability for analysis, instruments, and

　　work flows.

　　Review SOP’s and other lab documents as necessary.

　　Responsible for providing input on investigations (OOS, OOT, invalid assays and other laboratory

　　related non-conformances including investigations of audit observations) as business needs require.

　　Support investigation of aberrant data, results, atypical events occurring within the lab, and auditobservations by supporting cross functional investigation teams to identify root cause, evaluate

　　technical or product impact including the use of root cause analysis tools (K-T problem analysis,

　　Ishikawa, 5Whys).

　　Support the implementation of meaningful CAPAs and monitor effectiveness of CAPAs.

　　Responsible for Documentation Updates (procedures, work instructions, technical documents) in an

　　electronic management system.

　　Able to work shifts and weekends as well as overtime work on a scheduled or emergency basis.

　　Responsible for handling controlled substance in compliance with applicable State and local law and

　　J&J requirement

　　Carry out duties in compliance with all state and federal regulations and guidelines including FDA,ISO, EPA, OSHA and DEA; Adheres to with all company and site policies and procedures.

　　Provide documentation support for SOP/ Test Method revisions, identify and communicatenecessary document changes to management group to ensure timely revision to all SOP and test

　　methods records.

　　Perform other appropriate duties as assigned by the QC supervisor.

　　Must be willing to work a flexible schedule to support shift operations.

　　Maintain a clean and orderly workspace.

　　Qualifications

　　A minimum of a high school diploma is required.

　　A two-year technical degree in a science or laboratory related field is preferred.

　　A minimum of four (4) years of Experience in a Quality Control (GMP regulated) Laboratory is

　　required or a 4-year chemistry or related science degree.

　　Ability to apply mathematical operations to such tasks as frequency distribution, determinationof test reliability and validity, analysis of variance, correlational techniques, sampling theory,

　　and factor analysis is preferred.

　　Ability to identify and define problems, collect data, establish facts and make scientific basedconclusions is preferred.

　　Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals andmedical device. Ability to apply GMP regulations and other FDA and international guidelines to

　　all aspects of the position is preferred.

　　Experience in Lab Operations and Quality processes/systems in a GMP Lab setting is preferred.

　　Experience working with Lab Systems such as (e.g., LIMs, Documentum, Non-conformance

　　handling, Change Control) is preferred.

　　Familiarity with a variety of laboratory equipment, such as: (GC.HPLC, karl fisher, etc.) ispreferred.

　　Project Management Skills are preferred.Candidate must be willing to work from 10:00pm to 8:30am (3rd Shift) under rotating days schedule including weekends.

　　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.

　　Primary Location NA-US-Georgia-Athens

　　Organization Janssen Pharmaceuticals, Inc. (6062)

　　Job Function Laboratory Operations

　　Req ID: 2306156140W