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Quality Specialist II - 2406184055W
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 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 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:
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: 2406184055W