Quality Assurance (QA) Specialist II

Validation & Engineering Group, Inc.; Barceloneta (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a QA Specialist II to support manufacturing operations, investigate events, and ensure compliance with GMP and EHS standards.

The role includes leading investigations, risk assessments, CAPA documentation, and coordination with QA and plant teams. The position requires a Bachelor's (or higher) in a scientific or engineering field, with 4 years of pharmaceutical/biotech experience, and fluency in English and Spanish.

Qualifications

• Bachelor’s degree in Biotechnology, Biology, Chemistry or Engineering; Master’s preferred.
• Four years of experience in Pharmaceutical/Biotechnology industry in a similar position.
• Knowledge of GMP and safety regulations.
• Excellent written and spoken English and Spanish.
• Subject to work with multiple priorities and interruptions under pressure.

Responsibilities

• Support routine operations to ensure quality goals and compliance.
• Lead investigations and CAPA documentation in the plant.
• Perform product impact analyses and QA holds when needed.
• Participate on the Validation Review Board and approve SOPs and change management docs.
• Approve calibration requests and maintain records with proper justifications.
• Demonstrate EHS accountability and liaise with QA and Plant departments.
• Oversee manufacturing operations for alignment with procedures.
• Support internal and external audits.
• Provide guidance for new product introductions and risk assessments.

Skills

Quality systems

Investigations

Risk management

Bilingual EN/ES

GMP knowledge

Education

Bachelor’s degree in Biotechnology/Biology/Chemistry/Engineering

Master’s 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.