QA Specialist III

Validation & Engineering Group, Inc.; Barceloneta (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a QA Specialist III to implement and maintain the Quality System and support manufacturing operations. You will review investigations, assess product/process impact, and guide risk evaluations to ensure compliant disposition of products.

The role requires coordinating with multiple teams and ensuring CAPA and regulatory requirements are met. Strong knowledge of GMP and EHS practices is essential for success in this fast-paced environment.

Qualifications

• Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering.
• Experience in Quality preferably evaluating and conducting investigations.
• Teamwork and time management skills.
• Four (4) years of experience in Pharmaceutical/Biotechnology industry in a similar position.
• Knowledge of GMP, safety regulations.
• Quality/compliance management skills.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities

• Support routine operations to ensure quality goals are met and procedures comply with policies and regulations.
• Serve as backup for the QA Manager leading the team and supporting quality initiatives.
• Ensure investigations of plant events are evaluated in a timely and thorough manner.
• Perform product impact analyses and place products on QA hold when appropriate.
• Participate on the Validation Review Board as the Manufacturing QA function.
• Approve SOPs, change management and risk management documents, ensuring regulatory compliance.

Skills

Quality assurance

Investigations

Teamwork

Time management

English and Spanish communication

Education

Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• QA Specialist III

Description

Responsible for implementing and maintaining the effectiveness of the Quality System. Support manufacturing operations in the resolution of events, impact assessment and documentation discrepancies. Provide guidance for product/process impact analysis, perform holistic evaluation of events, review and approve investigations and risk based evaluations in support to routine operations and product disposition.

Responsibilities

• Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with policies and applicable regulations for the Quality areas under responsibility. Serve as backup for the QA Manager leading the team and providing support to quality initiatives.
• Ensures investigations of plant events are evaluated in a timely manner; completed thoroughly and documented accurately in the plant CAPA system.
• Performs product impact analyses for plant events and places product on QA hold where appropriate.
• Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approves standard operating procedures; change management and risk management documents. Ensures all documents are in compliance with global procedures and regulatory requirements.
• Approves calibration requests, calibration out of tolerance and preventive maintenance records. Ensures that these documents have appropriate justifications according to product /process limits established.
• Demonstrates accountability and responsibility of EHS performance and compliance.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments. Oversees manufacturing operations to ensure practices are in alignment with approved procedures.
• Provide support to the Compliance team during internal and external audits as required.
• Provide guidance for new product introduction activities. Develop risk assessments to support manufacturing activities for new products and ensure material control until regulatory approval.
• Conform to EHS management system requirements and compliance obligations, promote continuous improvement, and consider EHS aspects during the design and change process. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.
• SOP optimization project - experienced Quality representative to support Biologic Bulk Drug Substance manufacturing operations. Required experience in drug substance operations. Knowledgeable in the following aspects GMP, Process validation, CAPA/Investigations, Root Cause Analysis, Change Management, Risk Management, Annex 1 and FDA regulatory guidelines. Responsibilities include, provide guidance to cross functional team on the requirements and compliance aspects governing the changes to operational procedures in a fast pace project for optimization of procedures with the focus of reducing Human Error; review and approval of procedures and associated change records. Capable to work under minimum supervision, with critical timelines and commitments.
• Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices). Degree not required.

Qualifications

• Bachelors degree in Biotechnology, Biology, Chemistry or Engineering.
• Experience in Quality preferably evaluating and conducting investigations.
• Teamwork and time management skills.
• Four (4) years of experience in Pharmaceutical/Biotechnology industry in a similar position.
• This position requires knowledge of quality / compliance /Investigations /Risk management as well as regulations and standards affecting biological products.
• Excellent written and spoken communication skills in English and Spanish.
• Knowledge of GMP, safety regulations.
• Quality/compliance management skills.
• Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.