QA Specialist III

Validation & Engineering Group, Inc.; Barceloneta (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a QA Specialist III to implement and maintain the Quality System, support manufacturing events, and guide investigations and risk evaluations.

The role involves ensuring regulatory compliance across QA activities and coordinating with plant departments to uphold quality standards. Ideal candidates possess a biotechnical or engineering background, 4+ years in pharma/biotech, and strong writing and communication skills in

Qualifications

• Bachelor's degree in biotechnology, biology, chemistry or engineering.
• Four (4) years of experience in pharmaceutical/biotechnology industry in a similar position.
• Knowledge of GMP, safety regulations and cGxP.
• Excellent written and spoken English and Spanish.
• Proficient using MS Windows and Microsoft Office applications.
• Strong investigations, technical writing and risk-based evaluation skills.

Responsibilities

• Support routine operations to meet quality goals and comply with regulations.
• Serve as backup for QA Manager and lead quality initiatives.
• Ensure investigations of plant events are evaluated promptly and documented in CAPA system.
• Perform product impact analyses and hold products as needed.
• Participate on the Validation Review Board and approve QA documents.
• Assist in change management, calibration approvals, and maintenance records.
• Promote EHS compliance and coordinate with other quality areas and plant departments.

Skills

Bilingual English/Spanish

MS Windows

Microsoft Office

Regulatory knowledge

Investigations processes

Technical writing

Teamwork & time management

Education

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

Master's degree in Science preferred

Tools

CAPA system

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.

Qualifications

• Bachelors degree in Biotechnology, Biology, Chemistry or Engineering. Masters Degree in Science preferred.
• 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.
• Fast paced and adaptable to continuously changing environment. Subject to work with multiple priorities and interruptions and under reasonable pressure due to the nature and function of the area.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Technical Writing skills and investigations processes.
• Teamwork and time 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.

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.