SENIOR QUALITY SPECIALIST

Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Specialist 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.
anssen.
om and follow us @JanssenGlobal.
  This role ensures compliance with regulatory requirements and internal company procedures.
The position implements departmental strategies and maintains understanding and awareness of current and emerging regulations and the impact to quality practices.
This position coordinates and lead quality assurance programs designed to ensure effective and consistent processes with established standards.
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/or lead in regulatory audits and agency inspections.
Plan and coordinates quality assurance programs to ensure effective and consistent processes  with established standards.
Drafts, reviews, revise, approve, and authorize procedures, work instructions, protocols, validations, specifications, and qualifications within the controlled document system.
Responsible for overseeing controls and standards for Nonconformance, CAPAs and Change Control.
Initiative-taking and proactive  identification and mitigation of risk through metric reporting and other compliance programs.
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.
Provide support for establishing of quality Agreements with internal and external business partners.
Qualifications Education.
A minimum of a Bachelor’s degree is required.
Focus degree in Science, Engineering or other related degree is preferred.
Experience and Skills.
Required.
A minimum of 2 years of related work experience A solid understanding and experience in a cGMP/highly regulated manufacturing environment Strong collaboration and influence management skills to partner effectively across functions and operating units.
Excellent communication skills, able to inspire trust and build credibility.
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 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.
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 based on disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.