QA Specialist II

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. The firm provides specialized consulting and staffing solutions in Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, focusing on growth, operational excellence, and long‑term client success.

About the Role

Position: QA Specialist II – New York (Long‑Term)

The QA Specialist II will support quality operations in cGMP and FDA‑regulated environments, providing on‑floor QA oversight, maintaining quality systems and databases, identifying compliance risks, supporting investigations, and ensuring adherence to established quality and regulatory requirements.

Responsibilities

• Provide QA support and immediate corrective action for quality issues.
• Review quality control testing for compliance with SOPs and specifications.
• Author, review, and approve quality documents such as SOPs, deviations, CAPAs, and change controls.
• Support and participate in internal audits, external audits, investigations, inspections, and regulatory audits.
• Provide on‑floor QA oversight to manufacturing and operations activities.
• Identify compliance risks and support real‑time resolution of quality issues.
• Support investigations and assist with deviation management and corrective actions.
• Develop and maintain Quality System metrics for management review.
• Support training activities related to cGMP and quality system requirements.
• Perform QA visual inspection activities when required.
• Communicate quality issues, personnel performance, and improvement opportunities to management.
• Work closely with Quality, Manufacturing, Operations, QC, and other cross‑functional teams.
• Maintain quality databases and ensure accurate documentation.
• Ensure compliance with applicable cGMP, FDA, and internal quality requirements.

Qualifications

• Bachelor’s degree in Chemistry or a relevant scientific field with 3+ years of experience in pharmaceutical, biotechnology, medical device, or other FDA‑regulated industries, or Master’s degree in Chemistry or a relevant scientific field with 1+ year of relevant experience.
• Strong experience working in cGMP‑regulated environments.
• Knowledge of ICH Q7, Q9, Q10, and 21 CFR Parts 210 and 211.
• Experience with deviations, CAPAs, change controls, SOPs, and Quality Management Systems.
• Experience supporting audits, investigations, inspections, and quality documentation.
• Strong problem‑solving, communication, facilitation, and conflict‑resolution skills.
• Ability to work independently and collaborate with cross‑functional teams.
• Strong attention to detail, organization, and multitasking skills.
• Proficiency with Microsoft Office and quality‑related databases or software.