Johnson & Johnson Careers
Quality Control Analyst – 3rd shift
Requisition ID: 3701181004
Janssen Biotech, Inc. a member of Johnson & Johnson's Family of Companies, is recruiting for an Quality Control Analyst – 3rd shift. The position will be based in Malvern, Pennsylvania.
Janssen Biotech, Inc. delivers on the promise of new treatments and ways to improve the health of individuals with serious disease. Built upon a legacy of innovative firsts, Janssen Biotech pursues advancing patient care with immunology and oncology solutions. Please visit www.JanssenBiotech.com for more information.
The QC Analyst conducts biochemical, microbiological, and/or
general chemical testing of raw material, in-process, or final product samples
submitted to the QC laboratories. The position requires testing to be completed
in compliance with all applicable procedures, standards and GMP regulations.
In this role, you will complete testing in compliance with all applicable procedures, standards and GMP regulations.
Responsibilities include but are not limited to:
- Perform analytical testing in compliance with all applicable procedures and GMP regulations
- Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
- Conduct biochemical, microbiological, and/or general chemical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories
- Perform peer review of laboratory data. May approve laboratory data.
- Utilize electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing
- Execute analytical method qualification, validation, and transfer with guidance
- Update QC documents using the Document Management System
- Complete invalid assay and general laboratory investigation records
- Complete corrective and preventative actions (CAPA) as assigned
- Assist in the execution of internal audits
- Provide input and take actions as a QC representative at cross-functional meetings
- Other duties as assigned
- A minimum of a Bachelor’s Degree is required, preferably in a related science or technical discipline.
- A minimum of 2 years of experience in a GMP environment is required.
- Analytical technologies used in the QC laboratory experience is required.
- Ability to manage an individual project with minimal supervision.
- Experience with basic root cause analysis skills are a must.
- Solid understanding of applicable regulatory requirements is preferred\
- Significant laboratory documentation review and revision experience is required.
- Ability to write reports, business correspondence, SOP’s, protocols and reports is required.
- Strong interpersonal and communications skills in both written and oral is required.
- Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
- Candidates must be able to accommodate working outside normal business hours (including nights and weekends) on little to no prior notice.
- This position is located in Malvern, PA and may require up to 5% of domestic travel as business demands.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson Family of Companies are equal
opportunity employers, and all qualified applicants
will receive consideration for employment without
regard to race, color, religion, sex,
sexual orientation, gender identity, genetic
information, national origin, protected veteran
status, disability status, or any other
characteristic protected by law.
Janssen Biotech, Inc. (6014)