QA Specialist- Investigation and CAPA

J&J Family of Companies; Gurabo (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Johnson & Johnson is seeking a QA Specialist - Investigation & CAPA in Gurabo, PR to ensure the Investigations and CAPA Quality System remains in compliance with GMP, company SOPs, and regulatory requirements.

You will evaluate records, collaborate cross-functionally, monitor performance metrics, and assist with inspections. English/Spanish communication skills are required, with a background in pharmaceutical QA.

Qualifications

• Bachelor’s degree in a science or engineering field is required.
• Minimum 2 years of experience in investigations and CAPA in the pharmaceutical industry.
• Experience in parenteral or biological manufacturing is preferred.
• Knowledge of cGMP and GMPs is required.
• Fluency in English and Spanish (oral and written) is required.

Responsibilities

• Evaluate and approve records for Quality Investigations and CAPA.
• Collaborate with J&J affiliates and JSC functions; handle complaints regarding products manufactured at the site; coordinate investigation strategies.
• Support QA oversight of the Investigations and CAPA system by monitoring performance and reporting metrics.
• Assist in regulatory inspections and ensure closure of GMP issues from audits.
• Provide feedback and review procedures, protocols, and other documents related to Investigations and CAPAs.
• Escalate compliance issues to the Quality Manager for Investigations and CAPAs.

Skills

Investigations

CAPA

cGMP

GMP

Quality Systems

Regulatory Knowledge

English & Spanish

Education

Bachelor’s degree in science or engineering

Tools

ASQ Certified Quality Auditor

Job description

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Gurabo, Puerto Rico, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a QA Specialist- Investigation and CAPA to be located in Gurabo, PR.

The Quality Specialist (Investigations & CAPA) ensures that the Investigations and CAPA's Quality System is maintained in compliance with established company and corporate standard operating procedures, policies, rules, regulations, and current GMP guidelines.

You will be responsible for:

• Evaluate and approve records for Quality Investigations and Corrective Actions and Preventive Actions (CAPA).
• Collaborate with other J&J affiliates and JSC functions, and handle complaints from other J&J affiliates regarding products manufactured at the site. Coordinate strategies for investigation management.
• Support QA oversight of the Quality Investigations and CAPAs system by monitoring performance, and report metrics.
• Assist in regulatory inspections and ensure appropriate closure of any outstanding GMP issues from internal and external audits.
• Provide feedback and review procedures, protocols, and other documents related to Quality Investigations and CAPAs.
• Escalate compliance issues to the Quality Manager for Investigations and CAPAs.

Qualifications

Education:

• A minimum of a Bachelor’s degree is required or Bachelor of Engineering degree in Chemistry, Biology, Biochemistry, Microbiology, Engineering, Mathematics, or a related science is preferred.

Experience and Skills:

• A minimum of two (2) years of experience in related areas, such as management of investigations and CAPA processes, in the pharmaceutical industry.
• Experience related to parenteral manufacturing areas or biological manufacturing (preferred).
• Expert understanding of cGMP, Good Documentation Practices, and Regulations.
• Familiarity with US and International GMPs for pharmaceuticals.
• Good oral and written communication skills in both English and Spanish, including proficiency in technical writing.

Other:

• ASQ Certified Quality Auditor desirable.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

Required Skills:

Preferred Skills:

Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards