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Featured Employers
Senior Technician Quality Control (Multiple Openings)
Company: Johnson & Johnson
Location: Athens, GA
Employment Type: Full Time
Date Posted: 05/03/2021
Expire Date: 08/11/2021
Job Categories: Accounting/Auditing, Biotechnology and Pharmaceutical, Healthcare, Practitioner and Technician, Information Technology, Installation, Maintenance, and Repair, Quality Control, Research & Development, Medical
Job Description
Senior Technician Quality Control (Multiple Openings)

Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Technician Quality Control.

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.  Janssen Pharmaceuticals, Inc. is part of the Janssen Pharmaceutical Companies.


Essential Job Duties and Responsibilities
•    Set up, operate and clean laboratory equipment used to support production of intermediate or finished 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 audit observations 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.
•    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 communicate necessary 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 and a minimum of three (3) years of Experience in a Quality Control (GMP regulated) Laboratory OR a minimum of a bachelor’s degree in a chemistry or other related science field is required. 
•    A two-year technical degree in a science or laboratory related field is preferred.
•    Ability to apply mathematical operations to such tasks as frequency distribution, determination of 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 based conclusions is preferred.
•    Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and medical device is preferred. 
•    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.) is preferred.
•    Project Management Skills are preferred.
•    Working Rotating 6:00 am to 4:30 pm or 2:00 pm to 12:30 am shift including weekends is required


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.
 

 


Primary Location
United States-Georgia-Athens-1440 Olympic Drive
Organization
Janssen Pharmaceuticals, Inc. (6062)
Job Function
Quality
Requisition ID
2105902293W
Contact Information
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