AddressDescription
Janssen Pharmaceuticals, a member of Johnson & Johnson's Family of Companies, is recruiting for an QA Sr. Specialist - EQ AT either in Horsham, PA or 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/.
This position will provide QA technical support for External Manufacturers (EM) in the Americas. Review and approve quality system documents including SOP, specification and manufacturing instructions. Responsible for product release, ensuring products meet cGMP, Janssen specifications and regulatory requirements. Provide QA support for technology transfer and improvement of existing manufacturing processes. Contribute to the overall development, implementation, and execution of quality systems in support of to ensure complaint, product quality and product safety. Conduct investigations, perform GMP audits, collect data, analyze trends, and prepare management reports as required. Responsible for continuous improvement and risk management activities of EM.
Key Responsibilities:
- Reviewing batch documentation and product release
- Conducting and participating in manufacturing investigations.
- Reviewing and approving EM deviations
- Developing corrective action plans and monitoring implementation
- Review and approve change control
- Writing and implementing of quality procedures
- Providing QA support for technology transfer project
- Identifying and implementing continual improvements of manufacturing and quality/compliance processes
- Assess current process and systems and recommend improvements to enhance reliability and reduce cycle time.
- Analyzing product quality complaints and assisting the external manufacturer to complete complaint investigation
- Participating in quality audits at external manufacturers.
- Monitor quality trends, identify issues, recommend and implement appropriate actions to mitigate risk.
- Participate and support escalation process and issue management process
- Support regulatory inspections, manage JJRC reporting and monitor follow up on regulatory commitments
- Maintain Quality Agreement and specification changes.
- Travel to the EM site to provide on-site GMP oversight and support as needed.
- Providing support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and manufacturing.
- Remaining current with FDA and local regulations, guidelines, and quality practices associated with the pharmaceutical industry is required
- Computer proficiency in Microsoft Office tools with the ability to communicate effectively electronically.
- Continued development of knowledge and expertise as needed in order to perform job duties.
Qualifications
Education:
- A minimum of a Bachelor’s Degree with a preference in a Masters Degree
Experience and Skills:
Required:
- A minimum of 4 years in a FDA regulated environment is required
- Demonstrates knowledge of Quality Assurance, Quality Control and Compliance
- Ability to provide cGMP compliance support to contract manufacturers by investigating and resolving quality
- Demonstrates skills in the following Global Leadership areas: Integrity and Credo Based Actions, Sense of Urgency, Results and Performance Driven, Teamwork and Teaming and Prudent Risk Taking.
Preferred:
- Pharmaceutical / biologics manufacturing/cell or gene therapy or quality environment
- Experience in an aseptic environment
- Experience in the development, implementation, and review of SOPs for interactions with contract manufacturers
- Experience investigating customer Product Quality Complaints
Other:
- Up to 25% international travel required.
- The salary for this position, is anticipated to be between $$95,000 and $135,000
- 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
- Work, Personal and Family Time - up to 40 hours per calendar year
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.
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 .
