New · posted Nov 4
Johnson & Johnson · Pharmaceuticals
QA Specialist- Investigation and CAPA
- Gurabo, PR
- On-site
- Full-time
- Associate & Specialist
The role
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.
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.
Other
- ASQ Certified Quality Auditor desirable.
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.
We are searching for the best talent for a QA Specialist- Investigation and CAPA to be located in Gurabo, PR.
What you need
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.
- 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.
Preferred Skillsnice to have
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
Where you'll work
Gurabo, PROn-siteOpen in Maps (opens in a new tab)
More jobs in Gurabo, PRWorking conditions
Job Function
Quality
Job Sub Function
Quality Assurance
Job Category
Professional
All Job Posting Locations
Gurabo, Puerto Rico, United States of America
From the posting
About Johnson & Johnson
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
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.
Equal opportunity, accessibility and legal noticesJohnson & Johnson's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 4, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US71 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $56,250 | $77,000 | $88,750 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, November 4, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 348 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Johnson & Johnson's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Investigations and CAPA7
- Documentation and SOPs6
- GMP and compliance5
- Collaboration and leadership3
- Lab testing and methods1
- Quality systems and risk1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Assurance work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
Company hiring pulse
Johnson & Johnson on Regulatory Jobs
- 37
- Open roles
- 37
- Distinct roles
- 17
- Locations
By discipline
- Quality16 43%
- Clinical12 32%
- Regulatory9 24%
By level
- Manager11 30%
- Senior & Principal11 30%
- Associate & Specialist8 22%
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QA Specialist- Investigation and CAPA at Johnson & Johnson
Applications close November 11.