Quality Assurance (QA) Specialist II

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

Description:

The Quality Associate supports the Global Biologics Quality Function within Operations. The expectation is that the Quality Associate III will maintain high quality levels on all aspects of their job, while achieving high levels of efficiency.

Responsibilities:

• Responsible for Quality Assurance oversight of biologic products throughout the product lifecycle, ensuring compliance with cGMPs, regulatory requirements, and Quality Systems.
• Support quality-related activities including product transfers, quality initiatives, continuous improvement projects, and cross-functional business objectives.
• Manage and support change control records, including impact assessments, implementation activities, documentation, and effectiveness verification.
• Perform documentation, batch record, and data reviews, ensuring compliance with ALCOA+ data integrity principles and Good Documentation Practices.
• Oversee document management processes, including creation, review, approval, revision control, and archival of controlled quality documents.
• General knowledge in quality and business systems including SAP, OneTrack, TrackWise, OneVault, and other electronic quality management systems to support compliant operations.
• Communicate and collaborate effectively with management and cross-functional stakeholders regarding Quality initiatives, manufacturing activities, regulatory commitments, and business-critical projects.
• Ensure ongoing compliance with Quality Systems, cGMP regulations, regulatory expectations, and company policies while supporting inspection and audit readiness.

Qualifications:

• Bachelor’s Degree required; preferably in Physical or Life Sciences, Pharmacy, or Engineering.
• 2+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry.
• Must be familiar with use of statistical quality systems, electronic document management and laboratory information management.
• Must be familiar with cGMP and other regulatory requirements.
• Strong communication Skills, both oral and written.

What are the top 3-5 skills, experience or education required for this position:

1. Change and investigation documentation.
2. Bilingual.
3. Bachelor’s Degree in Science or Eng.
4. +2 years of experience in Quality area position.
5. If possible, experience with project management.

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.

What are the top 3-5 skills, experience or education required for this position:

1. Change and investigation documentation.
2. Bilingual.
3. Bachelor’s Degree in Science or Eng.
4. +4 years of experience in Quality area position.
5. If possible, experience with project management.

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.

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.