Janssen Biotech, Inc, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Quality Control Supervisor. The position will be based in Malvern, PA.
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 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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Quality Control Supervisor will:
• Oversees day-to-day Quality Control activities for designated sites/laboratories, ensuring compliance, accuracy and timeliness of specified testing processes (e.g., chemical and biochemical analysis of raw material, in-process, and finished product samples).
• Determines and distributes work assignments/priorities. Interacts with production to determine site needs.
• Communicates testing priorities and distributes work assignments to staff.
• Ensures that all testing/assays performed by laboratory staff are timely, compliant and validated for accuracy.
• Performs data review/auditing of analytical results produced by laboratory.
• Leads, manages and/or participates in the investigation of non-conformances in compliance with quality procedures, policies and regulations.
• Provides input on revisions and review of departmental procedures and documents (SOP’s, STM’s, QBR’s, URS).
• Ensures adequate training (skills-based, cGMP and Safety) of employees within department, to support production needs.
• Provides technical QC expertise at site, within and outside of department, in area of specialization.
• Acts as primary contact for manufacturing, quality groups and other departments at designated site(s).
• Assigns work, provides feedback and coaching, and takes necessary disciplinary actions, with management review.
• May oversee maintenance calibration and validation of laboratory equipment.
• Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA.
• Day to day supervision of a small team within a functional area. Performs similar tasks as team, but typically handles more complex tasks and analyzes issues that arise. Provides guidance.
A minimum of a Bachelor’s Degree, preferably in a related science or technical discipline, with 5+ years of experience in a regulated laboratory environment is required
• A minimum of 2 years of experience in testing procedures in a Quality Controlled environment is required.
• Solid understanding of applicable regulatory requirements is preferred.
• Experience with ICH Q7 and/or 21 CFR parts 210, 211, 600, 601, and 610 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.
• Ability to effectively present information and respond to questions from groups of managers and employees is required.
• Prior experience supervising, leading, or directly managing employees is preferred.
• Ability to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position is required.
• This position will be located in Malvern, PA and will require up to 5% of domestic travel, with potential for international travel.
Johnson & 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.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary LocationNorth America-United States-Pennsylvania-MalvernOrganizationJanssen Biotech, Inc. (6014)Job FunctionQuality Control
Internal ID: 4008171108
Location/Region: Malvern, PA (US)