QA Specialist- Investigation and CAPA
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About this opportunity
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
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 1505 comparable Quality roles across 148 biopharma companies.
Salary context
264 of 1505 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1505 comparable roles
+ 47 more countries
Seniority mix
728 of 1505 peers have a known seniority level
Therapeutic area mix
2 of 1505 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Currently open similar roles
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.