BioPharma Consulting JAD Group

Advises drugmakers on engineering and compliance

Quality Complaints Specialist - Product Investigations

Regulatory & Quality (Life Sciences)Updated on Nov 11

Full-timeJuncos, Puerto RicoNo salary listed

About the Job

Requirements

A Bachelor's degree plus 4 years, a Master's degree plus 2 years, an Associate's degree plus 8 years, a High School credential plus 10 years, or a Doctorate, with directly related experience.
GMP quality experience with complaint or quality investigations, root cause analysis, and CAPA determination.
Technical writing ability to turn a highly technical investigation into a clear document for non-technical reviewers.
Project management experience and experience leading cross-functional teams across multiple projects.
Strong communication, facilitation, and presentation skills, and ability to work independently in a matrix environment.
Proficiency in Microsoft Office, including Excel and Outlook, and Microsoft Teams.

Responsibilities

Keep the complaints database current and accurately summarize closed investigations.
Review and approve complaint investigations to ensure they are concise, clear, and science-based.
Lead and document investigations directly when the nature or complexity of a complaint requires it.
Follow up on corrective actions from investigations through completion.
Trend complaint data to detect signals proactively and recommend actions.
Communicate and escalate complaints, represent the site on the product complaint network, and issue closure letters to patients and business partners.

Desired Qualifications

Bilingual English and Spanish.

Quality Complaints Specialist - Product Investigations

BioPharma Consulting JAD Group · Juncos, Puerto Rico · Contract · Posted 2026-10-29

Workplace: on_site

Department: Amgen

Description

Support the product complaint system at a leading biotechnology company in Juncos, Puerto Rico. You will lead and manage product complaint investigations and use data analysis and trending to detect signals early and drive timely action.

What you'll do

Keep the complaints database current and accurately summarize closed investigations.
Review and approve complaint investigations to make sure they are concise, clear and science-based.
Lead and document investigations directly when the nature or complexity of the complaint requires it.
Follow up on corrective actions from investigations through completion.
Trend complaint data to proactively detect signals and recommend actions.
Communicate and escalate complaints, represent the site on the product complaint network, and issue closure letters to patients and business partners.

Requirements

Bachelor's degree + 4 years (or Master's + 2, Associate's + 8, High School + 10, or a Doctorate) of directly related experience.
GMP quality experience with complaint or quality investigations, root cause analysis and CAPA determination.
Excellent technical writing: able to turn a highly technical investigation into a clear document for non-technical reviewers.
Project management and experience leading cross-functional teams across multiple projects.
Strong communication, facilitation and presentation skills; able to work independently in a matrix environment.
Proficient in Microsoft Office (Excel, Outlook) and Teams. Bilingual English/Spanish preferred.

Benefits

Contract: 5 months, with possible extension
Shift: Administrative, Monday–Friday (40 hours/week)

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About the Company

BioPharma Consulting JAD Group

Advises drugmakers on engineering and compliance

BioPharma Consulting JAD Group advises pharmaceutical and biotechnology businesses on engineering, quality and regulatory compliance. It works with companies operating under US Food and Drug Administration rules to develop technical solutions for their manufacturing plants and processes. Its engineering practice covers facility and equipment design, process improvements and project management, while validation work verifies and documents that production systems meet requirements. The firm sells tailored consulting and technical support for assignments and projects, with company managers involved in delivery. Founded in 2010, it is headquartered in Cambridge, Massachusetts.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: Cambridge, MA
Founded: 2010

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