Specialist QA 35669

Inteldot; Juncos (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

Inteldot, a life sciences partner with operations across Puerto Rico, the US, Europe and Japan, seeks a Quality Assurance professional to support manufacturing, validation, and regulatory compliance. You will review deviations, CAPAs, and validation activities to ensure product quality and compliance on the floor.

Join a team that collaborates with Regulatory, Manufacturing, Validation, and Engineering to drive continuous improvement and effective quality management.

Qualifications

• Validated expertise in Quality Systems such as deviations, CAPA, and change control.
• Experience in computer systems validation or computer systems quality assurance for medical devices.
• Robust knowledge of manufacturing and distribution, QA, QAL, and Process Development.
• Experience with Validation Master Plan and IQ/OQ/PQ protocols, test scripts, and summary reports.
• Experience serving as Quality Contact for complex projects involving new products.
• Experience in commissioning and qualification.
• Strong organizational, communication, and presentation skills; ability to interact with regulatory agencies.
• Fluent in English and Spanish (written and oral).
• Data trending and evaluation abilities; ability to evaluate compliance issues.

Responsibilities

• On-the-floor review, approval, and tracking of cGMP processes, procedures, testing methods, documents, batch records, MES, EBR, SAP, EDMQ, DQMS, and Trackwise; incl. deviations, CAPAs, and validations.
• Lead continuous improvement initiatives and projects.
• Assess changes potentially impacting product quality per procedures.
• Ensure deviations are investigated and documented; ensure triage and records are current.
• Ensure production records and testing results are complete, accurate, and documented.
• Collaborate across Quality, Manufacturing, Process Development, Validation, QC, Warehouse, Engineering, and others per procedures.
• Serve as strategic advisor to senior management on quality, compliance, and safety risks.
• Support internal/external audits and inspections; act as Quality unit representative as needed.
• Ensure training compliance and task execution.
• Provide oversight for New Product Introduction (NPI).

Skills

Quality Systems

CAPA

Change control

GxP validation

IQ/OQ/PQ

Regulatory compliance

Quality Assurance

Process Development

Validation Master Plan

Deviations

Documentation

SAP

MES

Trackwise

English & Spanish

Education

Bachelor’s degree in Science or Engineering

Tools

SAP

Trackwise

EDMQ

DQMS

MES

EBR

Job description

Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Non Standard Shift

Job Description:

Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities.

Requirements & Qualifications:

• 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.

Functions:

• 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).

Education

• Bachelor’s degree in Science or Engineering + 4 years of directly related experience