Associate Quality Analyst II

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

Job summary

Validation & Engineering Group, Inc. seeks an Associate Quality Analyst II to oversee the quality system and ensure compliance across referral management, call center and fulfillment operations.

You will monitor regulatory adherence, analyze quality metrics, and support continuous improvement while maintaining customer satisfaction and efficient QA processes.

Qualifications

• Bachelor's degree in biotechnology, biology, chemistry, engineering or a related field.
• Minimum two years in a quality-related field; biotechnology experience preferred.
• Experience in quality/compliance management and investigation activities.
• Strong knowledge of regulations affecting biological products.
• Proficient with Word, Excel, Access and PowerPoint; good written/verbal presentation skills.
• Fully bilingual with strong teamwork and time management.

Responsibilities

• Implement and maintain the quality system effectiveness.
• Provide QA controls for referral management, call center and fulfillment operations.
• Monitor compliance with applicable policies and laws.
• Analyze quality metrics, trends and prepare reports daily and monthly.
• Manage QA lists, spreadsheets and databases for business operations.
• Participate in quality improvement initiatives and customer satisfaction.
• Investigate variances, incidents and exceptions and resolve them timely.
• Develop and implement permanent corrective actions.
• Prepare ad hoc quality and other reports for management and customers.
• Conduct internal audits and support external audit logistics.

Skills

Quality management

Data analysis

Communication skills

Teamwork

Problem solving

Microsoft Office

Bilingual

Mathematical/statistical basics

Education

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

Tools

Microsoft Office

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:

• Associate Quality Analyst II

Description

Responsible for implementing and maintaining the effectiveness of the quality system while providing quality oversight for referral management, call center, and fulfillment operations. Monitors compliance with applicable policies, procedures, and governmental regulations, supports quality improvement initiatives, conducts investigations, analyzes quality metrics and trends, and ensures customer satisfaction through effective quality management practices.

Responsibilities

• Implement and maintain the effectiveness of the quality system.
• Provide effective quality controls to referral management, call center, and fulfillment operations.
• Monitor compliance with Pharmacy Solutions policies and procedures, as well as applicable federal, state, and local governmental and pharmacy laws and regulations.
• Evaluate, analyze, and trend quality indicators, data, and performance metrics, and prepare daily and monthly quality reports.
• Manage QA lists, spreadsheets, and databases required to support business operations.
• Participate in Quality Improvement initiatives and assure customer satisfaction.
• Conduct investigations and provide timely resolution of variances, incidents, and exception issues.
• Participate in the development and implementation of permanent corrective actions.
• Prepare ad hoc quality and other reports as requested by management and external customers.
• Conduct internal audits of Pharmacy Solutions business functions and support external audit logistics and operations.

Qualifications

• Bachelor's Degree in Biotechnology, Biology, Chemistry, Engineering, or other scientific discipline, or related experience.
• Minimum of two (2) years of experience in a Quality-related field.
• Two (2) years of experience in the biotechnology industry.
• Experience in Quality, preferably evaluating and conducting investigations.
• Quality/Compliance Management skills and knowledge of regulations and standards affecting biological products.
• Strong computer skills utilizing Microsoft Office applications (Word, Excel, Access, and PowerPoint).
• Good oral, written, and presentation skills.
• Sound decision-making and problem-solving skills to ensure business unit compliance.
• Strong analytical skills with the ability to analyze data, identify trends, and draw conclusions.
• Good mathematics background with an understanding of basic statistical concepts.
• Fully bilingual.
• Strong teamwork and time management skills.
• Experience in parenteral and biotechnology plants is preferred.
• 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.