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Quality Control Senior Supervisor, Microbiology
Company: Johnson & Johnson
Location: Gurabo, PR
Employment Type: Full Time
Date Posted: 09/25/2021
Expire Date: 12/08/2021
Job Categories: Accounting/Auditing, Biotechnology and Pharmaceutical, Information Technology, Manufacturing and Production, Executive Management, Quality Control, Research & Development, Environmental, Writing/Authoring
Job Description
Quality Control Senior Supervisor, Microbiology

Janssen Ortho LLC, part of Johnson & Johnson Family of Companies, is recruiting for a Quality Control Senior Supervisor for the Microbiology Laboratory. The role will report into the Microbiology Manager.

 

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.  We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

 

As the Quality Control Senior Supervisor, you will be responsible for the direct supervision of Microbiology personnel shifts supporting the parenteral facility operations. You will be accountable for the microbiological aspects of the manufacture, validations and projects related to the parenteral area including but not limited to viable and non-viable air monitoring. You will approve release) of Laboratory tests in support of parenteral production such as Bacterial Endotoxin Tests (finished product, raw materials, WFI and Clean Steam), Bioburden and in process product tests, Sterility tests, Biological Indicators (BIs) testing, Environmental Monitoring of aseptic manufacturing areas, isolates identification (IDs).

 

You will support Disinfectant Efficiency Tests, Isolator’s qualification and new technology introduction. You will provide technical knowledge to make decisions related to product quality from the microbiological standpoint. Act as the Microbiology Specialist during health regulatory audits. Perform investigations and risk assessments when questionable microbiological results have been generated. Assure the compliance to all quality control policies, procedures, and systems to ensure the timely release of high-quality products of the supply chain process.

 

Key Responsibilities:

  • Coordinates routine and non-routine testing to support parenteral operations (BET, environmental monitoring, Sterility testing) with laboratory members to fulfill customers' needs.
  • Conducts and supports aseptic processing investigations
  • Develops and present metrics to support manufacturing microbiological data evaluation and trending.
  • Participates in external and internal cGMP audits.
  • Leads laboratory projects to assure compliance, costs reduction, laboratory operations efficiency and capacity's increase.
  • Performs, evaluates and/or approves laboratory (trending analysis, methods validations, methods transfers and special studies) protocols/report.

Qualifications
  • A minimum of a B.S. is required, a minor in Microbiology, Biology or Biotechnology is preferred. A Master’s Degree is desirable.
  • Process excellence certification (Yellow, Green Belt) is desirable
  • At least 6 years of experience in Quality is required
  • Working experience in parenteral operations is required.
  • Experience in a Microbiology Laboratory GMP environment, including supervisory experience, is required
  • Background in aseptic processing required
  • Experience with metrics and trends preparation required
  • Experience managing risk management tools and strong technical writing skills required
  • Experience with evaluation, review, and approval of all microbiological testing of parenteral products required
  • Familiar with Root Cause analysis and investigations related to microbiological tests required
  • Proficient in MS Office (Word, Excel, PowerPoint) and in laboratory data entry systems (e.g. eLIMS) required
  • Knowledge in method validations and transfers required
  • Familiarized with US and International GMPs and requirements for pharmaceuticals required
  • Solid understanding of USP, EP, JP and FDA and International Regulatory Requirements required
  • Customer oriented and interpersonal skills required
  • Proficiency in English (writing and speaking) and Spanish is required.
  • Must be able to travel less than 5 % to domestic and international destinations.

 

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-Puerto Rico-Gurabo-
Organization
Janssen Ortho LLC (2162)
Job Function
Quality
Requisition ID
2105963723W
Contact Information
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