• Title: Senior QA Scientist
• Location: Storrs, CT
• Industry: Pharmaceutical
• Salary: $46/hr.
• Employment Type: Contract

Job Overview:

Quality Systems & Compliance

• Design, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with applicable regulatory standards (ISO 9001, ISO 13485, 21 CFR Part 820, or industry equivalent).
• Lead and manage internal and external audits, including pre-audit preparation, execution, and CAPA follow-up.
• Maintain current knowledge of applicable regulations (FDA, EU MDR, ICH, GxP) and ensure organizational compliance through proactive gap assessments.
• Develop, review, and approve SOPs, work instructions, and quality documentation to ensure clarity and regulatory adherence.
• Oversee change control processes, ensuring all changes are properly documented, evaluated for risk, and validated prior to implementation.

Testing, Validation & Analytical Methods

• Design and execute validation protocols (IQ/OQ/PQ) for equipment, processes, software, and analytical methods.
• Develop and validate test methods in compliance with relevant pharmacopeial or industry standards; perform method transfers.
• Lead root cause investigation and failure analysis using structured problem-solving methodologies (8D, Ishikawa, 5-Why, FMEA).
• Review and approve batch records, test results, and deviations; ensure disposition decisions are science-based and defensible.
• Oversee stability programs, environmental monitoring, and in-process controls to ensure product integrity.

Cross-Functional Leadership & Continuous Improvement

• Serve as the quality representative on cross-functional project teams, providing QA guidance from design through launch.
• Partner with R&D, Regulatory Affairs, Manufacturing, and Supply Chain to drive quality-by-design principles.
• Lead Corrective and Preventive Action (CAPA) system; track and report trends in quality metrics to senior leadership.
• Mentor and coach junior QA staff, fostering a culture of quality, accountability, and continuous improvement.
• Identify and implement process improvement initiatives using Lean, Six Sigma, or other quality improvement frameworks.

Required

• Bachelor s degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline; Master s or Ph.D. preferred.
• Minimum 7 years of progressive, hands-on quality assurance experience in a regulated industry (pharmaceutical, biotech, medical device, or equivalent).
• In-depth knowledge of quality regulations and standards: FDA 21 CFR Parts 210/211/820, ISO 13485, ICH Q7/Q8/Q9/Q10, EU GMP Annex, or equivalent.
• Proven experience designing and executing validation protocols (process, method, equipment, CSV/computer systems).
• Demonstrated experience leading or supporting regulatory inspections (FDA, EMA, ISO/Notified Body) with successful outcomes.
• Strong root cause analysis skills with hands-on use of tools such as FMEA, Fishbone, 5-Why, and 8D.
• Experience authoring, reviewing, and approving complex quality documentation including SOPs, protocols, and technical reports.
• Proficiency with quality management software (e.g., MasterControl, Veeva, TrackWise, or similar platforms).

Preferred

• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent professional certification.
• Six Sigma Green Belt or Black Belt certification.
• Experience with electronic batch record systems and data integrity programs (21 CFR Part 11 / Annex 11).
• Prior experience with combination products or Class II/III medical devices.
• Familiarity with supplier quality management and qualification programs.

Core Competencies

• Regulatory & Compliance Expertise
• Strategic & Analytical Thinking
• Cross-Functional Collaboration
• Scientific Rigor & Attention to Detail
• Mentorship & Team Development
• Effective Communication & Documentation
• Problem Solving & Root Cause Analysis
• Continuous Improvement Mindset

• What is included in the biosecurity requirement? Employees may not own or have contact with live birds of any kind, including backyard poultry, ducks, turkeys, wild, or exotic birds, or visit farms, fairs, or other locations with bird exposure.
• What other animal contact is prohibited? Prohibited contact includes reptiles, amphibians, rodents, and certain wild animals (e.g., snakes, lizards, turtles, frogs, rats, mice, hamsters, guinea pigs, raccoons, skunks, opossums, squirrels, deer mice), or animals requiring feeding of rodents or raw/frozen animal products.
• What animal contact is permitted? Permitted animals include dogs, cats, fish, and traditional farm animals (horses, cattle, sheep, goats, pigs, llamas/alpacas). Employees may not handle raw or frozen meat or poultry products before work.
• How is biosecurity enforced? All candidates must complete a Biosecurity & Animal Ownership Disclosure Form prior to hire and certify ongoing compliance. Violations or falsification may result in disciplinary action up to and including immediate termination.

• Direct hire with long-term career stability
• 401(k) with company match
• Up to 3 weeks paid vacation
• Up to 11.5 paid holidays
• Medical, dental, and vision coverage
• Benefits effective the 1st of the month after your start date
• Consistent daytime schedule for work life balance
• Entry point into the life sciences and pharmaceutical industry
• Work that directly supports vaccines, diagnostics, and breakthrough therapies