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Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Associate II Cell Banking. This position will be located in Malvern, PA

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/.

In this role, you will be responsible for providing quality oversight of the GMP Cell Banking Center of Excellence and affiliated laboratories including the cryofreezer storage room located at the Great Valley Parkway in Malvern, PA. Additionally, you will be responsible for quality support of the QC Cell Banking laboratories at the Phoenixville Pike location in Malvern, PA. Primary responsibilities will include but are not limited to the Quality oversight of the production, testing, inventory, and supply of Master, Working, and development Cell Banks for clinical, and commercial production as well as analytical testing for J&J biopharmaceutical and cell therapy products. The candidate will act as a liaison with other internal quality organizations to standardize policies, practices, and procedures to increase quality and compliance and champion increased awareness of quality related concerns.

This position will also help guide the quality strategy to support the pipeline of cell banking testing and release requirements.

Main responsibilities will include, but are not limited to:

• Partner with Cell Banking GMP Operations team to provide Quality oversight to successfully manufacture cell line products and support processes in the cGMP facility.

• Perform on the floor real-time review of executed batch records and production documentation in support of batch release activities. Provide guidance with real time manufacturing and/or documentation discrepancies.

• Review and approve controlled documents including standard operating procedures, master batch records, test reports, COAs, work instructions, cell bank history reports, stability reports, technical study protocols and reports.

• Ensure all non-conformances are fully investigated per the Review and Approval process, effective corrective/preventive actions are implemented in a timely manner.

• Support site inspections and inspection readiness activities. Ensure Cell Banking COE, related laboratories and cryofreezer room are audit ready.

• Perform Quality oversight of GMP receipts related to the Cell Banking shipping process.

• Act as a change agent to increase quality understanding and maturity in the laboratories.

• Other duties may be assigned as necessary.

Qualifications

Education:

• A minimum of a Bachelor’s Degree is required with a focus in Engineering, Science, or equivalent technical discipline preferred.

Required:

• 2-4 years of experience, in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.

• Minimum of two years of experience with quality support in clinical or GMP manufacturing or support of laboratories is preferred.

• Experience in cell culture processing and Research & Development laboratories is preferred.

• Ability to work in an aseptic processing environment (Grade B or ISO 7) is preferred.

• Ability to be organized and capable of working in a team environment with a positive attitude under minimal supervision is required.

• A high degree of accuracy and attention to detail, and excellent interpersonal, oral, and written communication skills are required.

• Knowledge of cGMP regulations and FDA/EU guidance related to the manufacture of cell line products is preferred.

• Ability to maintain written records of work performed in paper-based and computerized quality systems is required.

• This position is located in Malvern, PA and requires on-site support.

Other:

• The anticipated base pay range for this position is 63,000 to 102,350 $USD.

• 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)).

• 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.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.