Regulatory / Compliance Specialist - Barceloneta

Integrated Services for Productivity & Validation, Inc; Barceloneta (PR); On-site; USD 75,000 - 115,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc in Barceloneta, Puerto Rico, seeks a Regulatory / Compliance Specialist for contract work. The role covers regulatory documentation, cGMP compliance, site transfers, and process qualifications.

The candidate will support Change Control, CAPAs, investigations and environmental guidelines, with 2+ years in regulatory roles and familiarity with CFR 21 and FDA/EU regulations. Requires flexibility for extended shifts.

Qualifications

• Bachelor's degree in science (chemistry, biology, engineering, pharmacy, microbiology, etc.).
• In-depth knowledge of process technology, cGMP’s, safety and environmental policies.
• 3-5 years of experience in the Pharmaceutical Industry with at least 2 years as Regulatory / Compliance Specialist
• Willing to work irregular and/or extended shifts if needed.
• Strong understanding of CFR 21, FDA and EU regulations among others.
• Microsoft Office applications, SAP, Trackwise and other programs related to function.
• Ability to work under minimal supervision, thorough knowledge of plant operations and ability to communicate to all levels of management.

Responsibilities

• Develop, review and/or approve PQR, DMF or other regulatory documents to assure compliance.
• Ensure PQR aligns with site schedule and regulatory due dates.
• Act as Quality representative in site projects (new product introductions/site transfer).
• Support qualification activities across site areas (equipment, process validation).
• Support completion of Change Control documents.
• Evaluate exceptions or investigations and participate in timely resolutions.
• Comply with environmental guidelines, training, and internal notifications of environmental events.
• Perform other assignments related to Quality Operations as required.

Skills

Regulatory compliance

CFR 21 knowledge

Communication to all levels

Ability to work with minimal supervis

Education

Bachelor's degree in science

Tools

SAP

Trackwise

Job description

Integrated Services For Productivity & Validation, Inc | Contract

Regulatory / Compliance Specialist - Barceloneta

Barceloneta, Puerto Rico | Posted on 10/02/2026

We provide the industry with a platform of solutions designed to their actual needs. We share and implement leading edge technology and methods that exceed customer expectation and deliver a one-stop provider of services focus on the well-being of the company and the employees.

Job Description

1 Develop, review and/or approval of Product QualityReviews(PQR), Drug Master Files (DMF) or any other regulatory document to assurecompliance and proper documentation according to product’s corporate policiesand regulatory requirements. Assure PQR comply with site schedule in order tocomply with Regulatory Affairs due date. Compile all information and datareview to evaluate process behavior and determine process capability limits.Submit PQR to applicable parties.

2 Act as Quality representative in site projects such as newproduct introductions/site transfer, providing guidance to all activitiesrequired to assure compliance with cGMP’s.

3 Provide support to the qualification activities for allareas of the site, including but not limited to:

a. Equipment mechanical and performance qualificationdocuments.

c. Process validation documents including cleaningprocesses.

4 Support completion of Change Control documents.

5 Perform evaluation of exceptions or investigations. Activelyparticipate in events discussions to assist in a timely resolution, includingOOX, Events, Deviations, Supplier Notifications, CAPAs.

6 Support other documents development and revision such asbatch records and SOP’s if necessary.

7 Comply with all environmental guidelines, procedures,training, practices, permit conditions, and internal notification of anyenvironmental events.

8 Will realize other assignments related to QualityOperations responsibilities, as required.

Requirements

• Bachelor's degree in science (chemistry, biology,engineering, pharmacy, microbiology, etc.).
  
• In-depth knowledge of process technology, cGMP’s, safetyand environmental policies.
  
• 3-5 years of experience in the Pharmaceutical Industrywith at least 2 years as Regulatory / Compliance Specialist
  
• Willing to work irregular and/or extended shifts ifneeded.
  
• Strong understanding of CFR 21, FDA and EU regulationsamong others.
  
• Microsoft Office applications, SAP, Trackwise and otherprograms related to function.
  
• Ability to work under minimal supervision, thoroughknowledge of plant operations and ability to communicate to all levels ofmanagement.