Supervisor Release Quality Control

Johnson & Johnson is recruiting for a Quality Control Supervisor, located in Raritan, NJ!

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

The Supervisor Release Quality Control is responsible for overseeing day-to-day Quality Control activities for a designated functional laboratory, ensuring GMP compliance, accuracy, and timeliness of specified testing processes. They carry out duties in compliance with all local, state, and federal regulations and guidelines (including FDA, EPA, and OSHA) as well as all company and site policies and procedures. They will also support internal and external audits. They will typically guide daily work activities of up to 15 direct staff within a functional laboratory of the Quality Control department. By joining our team, you will be part of a world-class organization that is driven by innovation, collaboration, and a commitment to excellence!

Key Responsibilities:

• Mentor, train, and supervise quality control staff, as well as evaluate performance and provide opportunities for growth
• Manage analyst schedule to support Drug Product testing
• Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards
• Review/approve documents as a QC department subject matter expert (SME)
• Oversee timely completion of laboratory investigation of OOS/ invalid assays, CAPAs and change controls
• Ensure accuracy and completeness of executed analytical method transfer activities
• Set testing priorities and manage work assignments
• Communicate department objectives and metrics
• Support internal and Health Authority audits, as well as audit related investigations

Qualifications

Education:

• Minimum of a Bachelor's or equivalent University degree required; advanced degree (MSc., Ph.D.) or focused degree in Biology, Biochemistry, or related scientific field is preferred

Experience and Skills:

Required:

• A minimum of 2 years of relevant work experience in Cell and/or Gene Therapy or Biologics
• A minimum of 1 years experience leading, coaching, or supervising direct or indirect personnel or teams
• Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
• Knowledge of cGMP regulations and Good Documentation Practices (GDP)
• Detailed knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards for QC testing

Preferred:

• Experience with statistical analysis and quality management systems.
• Knowledge of FDA regulations and cGMP guidelines.
• Lean Six Sigma certification and experience with continuous improvement initiatives.
• Experience with LIMs and SAP or equivalent systems

Other:

• This position is anticipated to have up to 10% travel
• The anticipated base pay range for this position is $76,000 to $115,000.
• This position's schedule is Sunday to Wednesday PM second shift. The anticipated shift would be roughly from 4PM to 2AM.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company's long-term incentive program.
• Employees are eligible for the following time off benefits:
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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