Quality Specialist II - 2406160755W

　　Description

　　Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Specialist II to be located at 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 (file:///C:/Users/jamie yacco/AppData/Local/Microsoft/Windows/Temporary Internet Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal.

　　This role ensures compliance with regulatory requirements and internal company procedures. Ensures company products follow internal and external specifications by performing a variety of routine and non-routine inspections and evaluations. Responsible for final product release decision in adherence to appropriate standard operating procedures and specifications.

　　Key Responsibilities:

　　Assesses compliance with cGMP regulations on difficult and complex technical issues.

　　Performs batch record review, control record review, and product disposition, including preparation of Certificates of Analysis.

　　Participates and assists with regulatory audits and agency inspections.

　　Participant in internal and customer audits; including completion of Facility and Systems Questionnaires.

　　Schedules, leads, and / or participates in the quarterly Site Quality Management Review.

　　Coordinates and completes associated activities with regards to customer complaints and inquiries

　　Drafts, reviews, revise, approve, and authorize procedures, work instructions, protocols, validations, specifications, and qualifications within the controlled document system.

　　Reviews, approves, and, in some cases, investigates non-conformances that could affect the quality of pharmaceuticals and medical devices.

　　Drives continuous proactive improvement of site quality system! Performs gap assessments with quality systems and Standards to ensure compliance.

　　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.

　　This position is not a supervisory role. However, this role is expected to collaborate and direct Quality Assurance requirements to impact overall site quality performance.

　　Qualifications

　　Education:

　　A minimum of an Associate degree is required, preferably in a science, engineering or other related degree.Experience and Skills:

　　Required:

　　A solid understanding and experience in a cGMP/highly regulated manufacturing environment

　　Excellent verbal and written communication skills

　　Must have skills to perform tasks without continuous supervision but seeking input as needed.

　　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 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.

　　Other:

　　This position require a 100% of the work On-Site in support of Manufacturing

　　Must be willing to work beyond traditional hours to support needs of business partners on a scheduled or emergency basis.

　　This position may require up to a 10% of domestic travel.

　　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 Quality Assurance

　　Req ID: 2406160755W