Ortho Biologics LLC is recruiting for a Senior Quality Systems Specialist, located in Manati, Puerto Rico.
This position is responsible for the review, approval, and compliance guidance to Technical Documents such as: CPV/ APR reports, Investigations, Statistical evaluations, Risk Assessments, Validation/ Qualification Protocols & Reports, etc. Position performs assigned duties in accordance to established company and corporate standard operating procedures, policies, rules and regulations, as well as in accordance with Current Good Manufacturing Practices (cGMPs) guidelines. Assists during external (regulatory, corporate, customer)/ internal inspections. In addition, is responsible to monitor progress of Quality Systems metrics and for evaluation and control of documentation associated to the position.
1. Supports Site Quality Compliance activities for Site GMP Readiness and during internal/ external inspections.
2. Leads the Site Quality Risk Management Program, Site Annual Product Review (APR) and Continuous Process Verification (CPV) Program activities.
3. Monitors Site compliance with the Global Procedures Gap Assessment process.
4. Supports Quality Metrics monitoring and issuance of the necessary action plans through the Business Performance Metrics (BPM) Tier 3/ Tier 4 Programs (or equivalent), Quality Systems Management Review (QSMR) and CAPA Review Board (or equivalent).
5. Directly supports Site Quality activities related to the established Quality & Compliance Escalation Process.
6. Executes the Indirect Materials and Service Providers Site QA Subject Matter Expert (SME) role as local process owner, per current procedures.
7. Reviews and approves documentation such as Non-Conformances (NC’s), Change Requests, Standard Operating Procedures (SOP’s)/ Work Instructions (WIs), Validation/ Qualification Protocols & Reports, special reports, etc.
8. Issues the Site Quality Plan per current Global procedures and monitors its progress.
9. Leads/ Supports Process improvement projects, as assigned.
- This position requires a bachelor’s degree in sciences (Pharmacy, Chemistry, Biology or Engineering). An MS/MA/MBA is highly desirable.
EXPERIENCE AND SKILLS:
- Minimum of six (6) years working experience in the Compliance, Regulatory or QA areas (Investigations, Change Control, CAPA, etc.).
- Strong knowledge in cGMP’s, Quality Risk Management, Quality Systems (Investigations, Change Control, CAPA, Internal Audits, Validation/ Qualification) and Regulatory Compliance.
- Applicable education and training on cGMP, Statistical Analysis, Quality Risk Management, Validation/ Qualification, and Regulatory Compliance.
- Proficient in the use of Microsoft Office (Excel, Word, and PowerPoint) and Internet.
- Strong documentation skills (English/ Spanish).
- Excellent Communication and People Skills.
- CQA preferred.
- CAPA Expert Certification preferred
- Lean/ Six Sigma (Green belt or Black belt) Certification preferred.
- Fluent in Spanish and English languages (both oral and written).
- Required to work regular shifts and frequently requires working overtime. Occasionally requires working on weekends and during holidays.
- May require 10% domestic and international travel.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
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.