Specialist QA 35768

Inteldot; Juncos (PR); On-site; USD 105,000 - 145,000; Full time

Job summary

Inteldot, a life sciences company with operations across Puerto Rico and the United States, seeks a Quality Assurance professional to support the QA program in manufacturing, process validation, regulatory compliance, and quality assurance activities.

Under minimal supervision, you will review documentation, lead investigations, support audits, and collaborate with Manufacturing, Validation, Engineering, and QA teams to ensure cGMP adherence and continuous improvement.

Qualifications

• Bachelor’s degree in science or engineering required.
• 4+ years directly related experience.
• Strong knowledge of cGMP requirements.
• Experience with QA systems and deviations/CAPA.

Responsibilities

• Review and approve QA documentation and batch records.
• Lead investigations and CAPA activities.
• Support internal/external audits and regulatory inspections.
• Collaborate across QA, Manufacturing, Validation, and Engineering.
• Ensure process validation and change controls are compliant.

Skills

Quality Assurance

Regulatory compliance

Process validation

GxP knowledge

Cross-functional collaboration

Bilingual English/Spanish

Education

Bachelor's degree in science or engineering

Tools

SAP

MES

TrackWise

EDMQ

DQMS

QMS Validation (IQ/OQ/PQ)

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 (12 working hours)

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:

• 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.

Functions:

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities.
• Support facilities and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment

Education

• Bachelor's in science or engineering+ 4 years of directly related experience