QA Specialist II

Stark Pharma Solutions Inc; City of Albany (NY); On-site; USD 90,000 - 110,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a QA Specialist II in New York to support quality operations in cGMP and FDA-regulated environments. The role provides on-the-floor QA oversight, maintains quality systems, and ensures compliance with regulatory requirements.

Responsibilities include review of testing, SOPs, deviations, CAPAs, change controls, and participation in internal and external audits. The candidate must collaborate with Quality, Manufacturing, and cross-functional teams while

Qualifications

• Bachelor's degree in Chemistry or related field with 3+ years in FDA-regulated industries.
• Master's degree in Chemistry or related field with 1+ year of experience.
• Strong experience in cGMP environments and regulatory expectations.
• Familiarity with ICH Q7, Q9, Q10 and 21 CFR Parts 210/211.

Responsibilities

• Provide QA oversight on the manufacturing floor and support CAPAs.
• Review control testing and ensure SOP and specification compliance.
• Author and review QMS documentation, deviations, and change controls.
• Support audits, investigations, inspections, and regulatory activities.
• Maintain QA metrics and collaborate with cross-functional teams.

Job description

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. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: QA Specialist II

Location: New York

Duration: Long Term

Job Overview

We are seeking a QA Specialist II to support quality operations in cGMP and FDA-regulated environments. The role will provide on-the-floor QA oversight, maintain quality systems and databases, identify compliance risks, support investigations, and ensure operations follow established quality and regulatory requirements.

Key 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-the-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.

Required 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.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.