Quality Assurance (QA) Specialist II

Veg Group; Barceloneta (PR); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Equal opportunity employer

Job summary

Validation & Engineering Group, Inc. is seeking a QA Specialist II to support manufacturing operations and maintain the quality system in a fast-paced environment.

The role includes handling events, CAPA, risk-based evaluations, and product disposition with strong collaboration across QA and manufacturing teams. The candidate should have a Bachelor’s in biotechnology, biology, chemistry or engineering, plus 4 years in pharma/biotech, with English and Spanish proficiency and knowledge of GMP and

Qualifications

• Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering required.
• Four (4) years of experience in Pharmaceutical/Biotechnology industry in a similar position.
• Knowledge of GMP, quality/compliance, investigations and risk management.
• Excellent written and spoken communication in English and Spanish.

Responsibilities

• Implement and maintain the quality system and ensure regulatory compliance.
• Lead investigations, risk assessments, and CAPA activities for plant events.
• Review and approve investigations, change controls, and SOPs; support audits.
• Provide guidance for product disposition and material control until regulatory approval.
• Collaborate with QA Manager and manufacturing to meet quality goals.

Skills

Quality management

Investigation & CAPA

Regulatory compliance

Bilingual English/Spanish

Education

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

Masters Degree in Science preferred

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:

• Quality Assurance (QA) Specialist II
• Shift: Associate Rotating shift – 4 days at 10hours.

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.
• Assures the quality of manufactured products and processes per standard operating processes (SOP'S) and GMP (Good Manufacturing Practices). BS degree or 3-5 years equivalent experience.
• Technical Writing skills and investigations processes.
• 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.