Quality Specialist II
Job Description
Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Specialist II in Athens, GA!
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.Janssen Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.
This role ensures compliance with regulatory requirements and internal company procedures. Responsible for facilitating the QA Department’s daily activities with emphasis on cGMP.
This position is not a supervisory role. However, this role is expected to guide on Quality Assurance requirements to impact overall site quality performance.
Key Responsibilities
• Performs batch record review, control record reviews, including preparation of Certificates of Analysis.
• Reviews and in some cases, investigates non-conformances that could affect the quality of pharmaceuticals and medical devices.
• Support Quality Assurance Shop floor/walkthroughs standards monitoring.
• Provides input to management on quality and compliance. Ensures corrective actions implemented are effective.
• Supports strategic site and segment projects and initiatives, including New Product Introductions.
• Document quality assurance activities with use of checklists and reports.
• Assist Operations through mentorship on Good Documentation Practices.
Education
• A minimum of an Associate’s degree or equivalent is required, preferably in a science, engineering, planning or other related discipline.
Experience and Skills:
Required
• A minimum of two (2) years of working knowledge and experience in a cGMP/highly regulated manufacturing environment.
• Must have proven skills to perform tasks accurately.
• Must have skills to perform tasks without continuous supervision but seeking input as needed.
• Eye for detail and accuracy.
• Confirmed ability to complete tasks while maintaining consistency of work.
• Demonstrated ability to work on complex or ambiguous issues autonomously, with little/no daily direction.
• Read, understand and interpret documents such as operating procedures, safety rules, government regulations, operating and maintenance instructions, business periodicals, professional journals and technical procedure manuals.
• Strong troubleshooting skills to assist with defining problems, collection of data, establishment of facts and drawing valid conclusions.
• Draw conclusions from trending analysis and initiate appropriate actions.
• Must have proficient knowledge of cGMPs, safety and environmental regulations as they apply to a pharmaceutical or chemical manufacturing environment.
• Must have strong technical and troubleshooting skills as demonstrated through prior performance achievements.
Preferred:
• Proficient with Microsoft Office software programs. Ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations.
• Understand Quality Systems Regulations, cGMP/GLP regulations, ICH Q7, and FDA requirements for pharmaceuticals and medical devices.
• Able to lead multiple initiatives daily while being flexible and responsive to shifting priorities when needed.
• Ability to apply risk management philosophy to business processes, decisions and data.
• Ability to influence and collaborate with global and cross-functional teams and multiple partners at all levels of the organization.
• Resolves conflicts effectively.
Other:
• Occasionally required to climb (stairs/ladders); stoop, kneel, crouch, or crawl; and smell.
• Specific vision abilities required by this job include close vision, color vision, distance vision and ability to adjust focus.
• Must be willing to work beyond traditional hours to support needs of business partners on a scheduled or emergency basis.
• Ability to travel <10%.
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.
Primary Location
NA-US-Georgia-Athens
Organization
Janssen Pharmaceuticals, Inc. (6062)
Travel
Yes, 10 % of the Time
Job Function
R&D
Qualifications
Job Qualifications
Hospitals and Health Care
Quality Assurance
Full-time