QA Specialist- Investigation and CAPA

Johnson & Johnson; Gurabo (PR); Presencial; USD 60.000 - 85.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

ASQ Certified QA Auditor

Descripción de la vacante

Johnson & Johnson in Gurabo, Puerto Rico is seeking a QA Specialist—Investigations & CAPA to maintain the Quality System in line with GMP and corporate SOPs. You will manage investigations, CAPA and related documentation, ensuring compliant closure of issues.

Role requires experience in pharma QA, ability to work cross-functionally in a bilingual environment and strong written communication in English and Spanish. Knowledge of cGMP is essential.

Formación

• A minimum of two (2) years of experience in investigations and CAPA in the pharmaceutical industry.
• Experience with parenteral or biological manufacturing is preferred.
• Familiarity with cGMP, GxP, and international GMPs; strong written and spoken English/Spanish.

Responsabilidades

• Evaluate and approve records for Quality Investigations and CAPA actions.
• Collaborate with J&J affiliates and JSC functions; coordinate investigation strategies.
• Monitor performance of QA Investigations and CAPA system and report metrics.

Conocimientos

Business Alignment

Data Analysis

Detail-Oriented

Internal Controls

Issue Escalation

Problem Solving

Process Oriented

Quality Control

Quality Management Systems

Quality Standards

Educación

Bachelor's degree in Chemistry/Biology/Biochemistry/Microbiology/Engineering/Mathematics or related science

Descripción del empleo

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:

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

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