Quality Documentation Analyst

anssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Documentation Analyst in Athens, Georgia.

At Janssen, we never stop working toward a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension. Visit us: www.janssen.com

This role ensures compliance with regulatory requirements and internal company procedures.

Responsible for executing task related to site Document Control and Training electronic systems.  These activities include records management and the administration of systems, and the management of controlled documents through revision, review, and approval processes. 

Key Responsibilities:

• Carries out administration of the Electronic Document Management System at the site.
• Reviews, revise, approve, and authorize procedures, work instructions, protocols, validations, specifications, and qualifications within the controlled document system.
• Drives continuous proactive improvement of site quality system! Performs gap assessments with quality systems and Standards to ensure compliance.
• Coordinates the Records Management Policy for the site and carries out asks related to the storage and archiving of GMP documents including validation documents
• Generates reports and metrics from the electronic systems.  Track employee overdue training.  Manage the document periodic review process.
• This position is not a supervisory role. However, this role is expected to collaborate and ensure requirements to impact overall site quality performance.

Education:

• At a minimum high school graduate with 2-3 years of relevant experience.

Experience and Skills:

Required:

• Operational experience with electronic quality systems.
• - Experience with Document Management Systems (TruVault)
• - Strong written and verbal communication skills, and analytical problem solving and conflict resolution skills.
• - Flexible, highly motivated, with strong organization skills, ability to multi task with attention to detail.
• - Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• - Proficient knowledge of Microsoft Office.
• - Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
• Must have skills to perform tasks without continuous supervision but seeking input as needed.
• 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.
• Must have knowledge of cGMPs, safety and environmental regulations as they apply to a pharmaceutical or chemical manufacturing environment.

Preferred:

• Ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations.
• 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.
• GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21CFR, ICH Q7)

Other:

• 100% of the Work is On-Site
• Must be willing to work beyond traditional hours to support needs of business partners on a scheduled or emergency 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.