QC Lab Analyst 1

Job description

Job Description

Requisition ID: 1854190411

Janssen Supply Group, LLC Part of the Janssen Pharmaceuticals Inc and Johnson & Johnson Family of Companies, is recruiting for a QC Lab Analyst I based in Raritan, New Jersey.

Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visitwww.janssenpharmaceuticalsinc.com

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.

Summary

You will be responsible for executing analytical testing according to testing schedules in a most compliant and efficient manner. Prior to conducting your analysis your will be responsible for ensuring the instrumentation is properly calibrated while maintaining a safety and orderly work environment.

Responsibilities
·  Responsible for analytical testing from receiving the sample to entering final data in eLIMs. Including but not limited to assay, impurity, appearance, pH, UV, dissolution, viscosity, Hardness, particle size, etc.
·  Review analytical testing data- Notebooks, Empower, eLIMs testing data entry, Trending, etc.
·  Initiate analytical investigations providing inputs and support to investigations.
·  Process data and report data in a cGMP and data integrity manner following the ALCOA principles.
·  Maintain instrumentation through good operator asset care involving daily instruments maintenance. Troubleshooting minor issues that can be fixed quickly.
·  Keeping the Lab clean and orderly in a consist state of inspection readiness following 6S principles.
·  Participate in the everyday meeting with the Lab Supervisor to review testing schedule.
·  Identifying opportunities to improve safety and reporting as good saves.
·  Support lab audits as required

Desired profile

Qualifications

·  A Bachelor's degree in a science field required. Analytical Chemistry is preferred
·  2 years of experience in a Quality Control (GMP regulated) Laboratory is required
·  Basic understanding of analytical concepts and instrumentation (e.g. separation chemistry, identification or quantitation concepts, HPLC, UPLC, GC, Dissolution, UV, Viscosity, etc.) is required
·  Basic knowledge in chromatography and analytical chemistry in a cGMP environment is preferred.
·  Must be able to troubleshoot instruments with some guidance
·  Knowledge of Lab software systems (LIMS, Trackwise, Empower) is preferred
·  Knowledge of current Stability guidelines and Industry Standards are preferred.
·  Good communication and interpersonal skills
·  Knowledge of cGMP, Health Authority guidelines and regulations (FDA, EMA, Health Canada, ICH, etc.)
·  Experience with Microsoft Office applications such as word, excel, power point, and SharePoint
Primary Location
United States-New Jersey-Raritan-
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality Control
Requisition ID
1854190411