QA Specialist II

Stark Pharma Solutions Inc; City of Albany (NY); On-site; USD 70,000 - 90,000; 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 involves on-the-floor QA oversight, maintaining quality systems, and ensuring adherence to regulatory requirements.

You will review QC testing, author and approve quality documents, and participate in internal and external audits, investigations, and inspections. Collaboration with Manufacturing, Quality, and Operations is essential.

Qualifications

• Bachelor's or master's degree in a science field with regulatory exposure.
• Experience in cGMP environments and FDA-regulated industries is required.
• Ability to review deviations, CAPAs, change controls, SOPs, and quality docs.

Responsibilities

• Provide QA oversight in cGMP/FDA-regulated operations.
• Review and approve quality documents (SOPs, deviations, CAPAs, change controls).
• Support internal/external audits, investigations, and inspections.
• Maintain quality system metrics and collaborate with cross-functional teams.

Skills

cGMP experience

Regulatory knowledge

Audit support

Documentation

Cross-functional

Detail oriented

Communication

Education

Bachelor's degree in Chemistry or relevant field

Master's degree in Chemistry or relevant field

Tools

Microsoft Office

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.

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.