Validation & Engineering Group, Inc.

Associate Quality Analyst II

Validation & Engineering Group, Inc.  •  Carolina, PR (Onsite)  •  3 hours ago
Apply
AI can make mistakes so check important info. Chat history is never stored.

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

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.

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.

Validation & Engineering Group, Inc.

About Validation & Engineering Group, Inc.

Validation & Engineering Group, Proudly serving our clients since 1997.

Our Mission states in part: "provide our clients with the best resources to meet their needs". In our search for the best talent, we are inclusive and do not discriminate. V&EG is proud to be an equal opportunity workplace and is an affirmative action employer.

Validation & Engineering Group provides world-class service and expertise to the pharmaceutical, medical device and biotechnology industries. We offer our clients: Validation, Control System Solutions, Instrumentation, Training, Equipment Rentals, and Regulatory Compliance Services to ensure adherence to Federal and European regulatory agencies. Our group had serve in solid dosages, liquids, creams, lyophilizers, and parenteral dosage.

Our agility in responding to our clients’ needs, access to the best pool of talent, and the combined experience and technical expertise of our resources make Validation & Engineering Group a leader in the pharmaceutical, medical devices, and biotechnology industries.

At Validation & Engineering Group we provide professional expertise in the areas of:

•Audit and Assessment

•Automated Process Control System Qualification

•Equipment and Facilities Qualification

•Facilities Start-Up and Commissioning

•GAP Analysis

•Information Systems Computer Validation

•Packaging and Process Analysis

•Process & Cleaning Validation

•Project Management

•Quality Systems

•Risk Based Approach

•Regulatory Compliance

•Standard Operating and Maintenance Procedures

•Training

•Utilities Support and Qualification

In addition we offer Equipment Rentals and training to your workforce such as: Temperature & Relative Humidity, Electrical, Process, Environmental, and. Analytical.

Our Offices:

Puerto Rico:

Centro Internacional de Mercadeo I 100 Carr. 165 Ste 703, Guaynabo, 00968 Puerto Rico

Phone: (787) 622-0996

United States:

2180 Satellite Blvd, Suite 400Duluth, Georgia 30097 United States

Phone: (770) 403-5802

Industry
Architecture & Engineering
Company Size
51-200 employees
Headquarters
Guaynabo, PR
Year Founded
1997
Social Media