Specialist QA II

Validation & Engineering Group, Inc

Barceloneta, 017

JOB DETAILS
SKILLS
Analysis Skills, Biology, Biotech and Pharmaceutical, Chemistry, Communication Skills, Corporate Policies, Corrective Action, Cross-Functional, Healthcare, Maintain Compliance, Manufacturing, Medical Equipment, Natural Science, Presentation/Verbal Skills, Process Management, Procurement Management, Production Support, Project/Program Management, Purchasing/Procurement, Quality Assurance, Quality Assurance Methodology, Regulations, Regulatory Requirements, SAP, Scorecarding, Software Testing, Systems Maintenance, Usability Engineering, Vendor/Supplier Evaluation, Vendor/Supplier Management, Writing Skills
LOCATION
Barceloneta, 017
POSTED
21 days ago

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:

  • Specialist QA II

Description:

The Quality Analyst is responsible for the resolution of supplier-related issues, including investigations and corrective actions, maintenance of supplier status, evaluation and closure of supplier change notifications (SCNs), supplier scorecards, and SQA reports.

This role ensures the quality and compliance of incoming materials by working closely with suppliers and internal cross-functional teams. The position operates primarily in an office environment with occasional visits to production areas, supporting quality assurance processes in alignment with regulatory and company standards.

Key Responsibilities:

  • Coordinate resolution of quality and performance issues related to purchased materials with suppliers and Manufacturing Quality Assurance.

  • Monitor and manage implementation of processes impacting vendor product quality.

  • Establish and maintain communication with suppliers regarding quality issues (nonconformities, deviations, defects, waivers).

  • Assess and track Supplier Change Notifications (SCNs) to ensure timely review and closure.

  • Evaluate specification exceptions and escalate to management when necessary.

  • Maintain SAP system data including specifications, supplier approvals, and purchasing controls.

  • Collaborate with internal departments to ensure integrity and usability of incoming materials.

  • Serve as liaison between Quality, Manufacturing, and external partners.

  • Support follow-up and closure of management review action items.

  • Ensure compliance with company policies and applicable regulatory requirements.

Qualifications:

  • Bachelor’s degree in Natural Sciences, Biology, Chemistry, Engineering, or related field.

  • Minimum of 5 years of experience in the pharmaceutical, medical device, or healthcare industry.

  • Experience in supplier quality and/or incoming quality preferred.

  • Strong problem-solving and analytical skills.

  • Effective verbal and written communication skills.

  • Strong interpersonal and negotiation skills.

  • Bilingual (preferred).

  • Experience with supplier management processes.

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.

About the Company

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Validation & Engineering Group, Inc