Senior Quality Analyst

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

Job summary

Validation & Engineering Group, Inc. in Puerto Rico seeks a Senior Quality Analyst to uphold quality, compliance, and investigations across pharmaceutical operations.

You will lead QA activities, support CAPA, and ensure adherence to GMP and safety standards while communicating across bilingual teams. The ideal candidate has a Bachelor's (or higher) in biotech/chem eng, 4 years in pharma/biotech, and strong quality/compliance skills; fluent in English and Spanish, capable under pressure, and

Qualifications

• Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering; Master's degree in Science preferred.
• 4 years of experience in Pharmaceutical/Biotechnology industry in a similar position.
• Knowledge of quality/compliance/investigations/risk management as well as regulations 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.

Responsibilities

• Support routine operations to ensure quality goals are met and practices comply with policies and regulations.
• Serve as backup for the QA Manager and support quality initiatives.
• Ensure investigations of plant events are timely, thorough, and documented in the CAPA system.
• 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.
• Ensure documents comply with global procedures and regulatory requirements.
• Approve calibration requests and preventive maintenance records.

Skills

Communication skills

Quality management

Education

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

• Senior Quality Analyst

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.

Responsibilities

• * Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with the company 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 the company 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.

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.