Specialist QA

QRC Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

QRC Group in Juncos, Puerto Rico is seeking a Sr. Specialist QA with extensive experience in regulated manufacturing environments. The role focuses on on-the-floor QA review, deviation management, CAPA, and validation activities to ensure cGMP compliance and product quality.

The candidate will collaborate across QA, Manufacturing, Validation, and Engineering, support audits, and contribute to continuous improvement, NPI, and regulatory interactions. Bilingual English/Spanish skills are required.

Qualifications

• Bachelor's degree in Science or Engineering with 4 years of related experience.
• Experience in regulated manufacturing including cGMP, deviations, CAPAs, and validation.
• Strong collaboration across QA, Manufacturing, Validation, Quality Control and Engineering.
• Experience in computer systems validation for medical devices.
• Ability to interact with regulatory agencies.
• Bilingual in English and Spanish.

Responsibilities

• Perform on-the-floor PQA review, approval, and tracking of cGMP processes, procedures, testing methods, documents and records.
• Investigate deviations, CAPAs, and validations; ensure triage and deviation records are initiated.
• Ensure production records and testing results are complete and documented per procedures.
• Support internal and external audits and inspections; act as Quality unit representative as needed.
• Provide support for New Product Introduction (NPI) and continuous improvement initiatives.
• Champion continuous improvement initiatives and projects.

Skills

On-the-floor QA

Cross-functional collaboration

Regulated industry experience

Regulatory communications

Bilingual English/Spanish

Data trending

Documentation proficiency

Education

Bachelor's Degree in Science or Engineering

Tools

MES

EBR

SAP

EDMQ

DQMS

Trackwise

Job description

Juncos, Puerto Rico

We are seeking a Sr. Specialist QA with experience in regulated industries:

• Perform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing methods in manufacturing, documents and records, batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise; including but not limited to deviations, CAPAs, and validations.
• Actively engage in continuous improvement initiatives, programs, and projects.
• Vigilantly ensure that changes potentially impacting product quality are assessed according to procedures.
• Certify that deviations from established procedures are investigated and documented per procedures and ensure on-the-floor triage is completed, documented, and current procedural controls are achieved, including ensuring the initiation of deviation records.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Require strong collaboration and cross-functional partnership to ensure the Quality Management System, Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Contractors, Environmental, Facilities, and other processes are executed according to established procedures.
• Serve as a strategic advisor to senior management regarding quality, compliance, supply, and safety risks.
• Support internal/external audits and inspections as part of the audit/inspection management team, including acting as Quality unit representative as needed.
• Accountable for adherence to assigned training, permitting execution of required tasks.
• Champion continuous improvement initiatives and projects.
• Provide support and oversight for New Product Introduction (NPI).
• Demonstrate validated expertise in Quality Systems such as deviations, CAPA, and change control.
• Exhibit experience in computer systems validation or computer systems quality assurance, particularly with medical devices and/or consulting background technical proficiency.
• Possess robust knowledge and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
• Experience with validation of GxP applications, including development of Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) protocols, test scripts, and completion/summary report approvals per compliance requirements.
• Validated experience serving as Quality Contact for complex projects involving new products.
• Validated experience in commissioning and qualification.
• Strong organizational skills, including the ability to follow assignments through to completion.
• Enhanced skills in leading, influencing, and negotiating.
• Demonstrate the ability to interact effectively with regulatory agencies.
• Solid word processing, presentation, database, and spreadsheet application skills.
• Strong communication skills in English and Spanish (both written and oral), facilitation, and presentation skills.
• Proven skill in working independently and effectively interacting with all levels throughout the organization.
• Advanced data trending and evaluation abilities.
• Ability to evaluate compliance issues.

Requirements

• Education: Bachelors Degree in Science or Engineering + 4 years of directly related experience.