Quality Assurance Engineer

Stark Pharma Solutions Inc; City of Rochester (NY); On-site; USD 70,000 - 90,000; Full time

Job summary

Stark Pharma Solutions Inc is looking for an experienced Quality Assurance Engineer to join our team in Rochester, NY. In this role, you will support quality assurance activities in a pharmaceutical environment, ensuring product quality and regulatory compliance.

The ideal candidate will possess a Bachelor's Degree in a relevant discipline with 2–5 years of experience in Quality Assurance. Key responsibilities include conducting audits, regulatory inspections, and collaborating with teams to enhance quality standards.

Qualifications

• 2-5 years of Quality Assurance experience in regulated environments.
• Hands-on experience with quality inspections and audits.
• Excellent communication skills.

Responsibilities

• Perform quality inspections and audits.
• Review batch records and ensure compliance.
• Investigate quality issues and support CAPA.

Skills

FDA regulations

GMP

ISO 13485

Quality Management Systems (QMS)

CAPA

Root cause analysis

Data analysis

Education

Bachelor's Degree in Engineering or Life Sciences

Job description

Job Title: Quality Assurance Engineer

Location: New York

Duration: Long Term

Position Overview

We are seeking an experienced Quality Assurance Engineer to support quality assurance activities within a pharmaceutical, biotechnology, or medical device manufacturing environment. This role will focus on ensuring product quality, regulatory compliance, and continuous process improvement by supporting quality systems, inspections, audits, documentation, and CAPA activities. The ideal candidate will have strong knowledge of FDA regulations, GMP, ISO standards, and quality management systems while collaborating with cross‑functional teams to maintain the highest quality standards.

Key Responsibilities

• Perform quality inspections, manufacturing audits, and process reviews to ensure compliance with quality standards.
• Review batch records, device history records, and quality documentation for accuracy and regulatory compliance.
• Ensure compliance with FDA regulations, GMP, ISO 13485, and company quality management systems.
• Investigate quality issues, non-conformances, deviations, and customer complaints, and support CAPA activities.
• Participate in internal audits, supplier audits, and regulatory inspections while ensuring audit readiness.
• Collaborate with Manufacturing, Engineering, Regulatory Affairs, Validation, and Quality Control teams to improve product quality and manufacturing processes.
• Develop, review, and maintain quality procedures, SOPs, work instructions, and technical documentation.
• Support risk assessments, root cause analysis, change control, and continuous improvement initiatives.
• Monitor quality metrics and analyze trends to identify opportunities for process improvement and operational excellence.
• Ensure compliance with company quality policies and applicable regulatory requirements throughout the product lifecycle.

Required Qualifications

• Bachelor's Degree in Engineering, Biotechnology, Life Sciences, Chemistry, Biology, or a related scientific discipline.
• 2 5 years of Quality Assurance experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Strong knowledge of FDA regulations, GMP, ISO 13485, CAPA, Quality Management Systems (QMS), and regulatory compliance requirements.
• Experience performing quality inspections, manufacturing audits, documentation review, and quality investigations.
• Hands‑on experience with deviations, non-conformances, root cause analysis, CAPA, and change control processes.
• Familiarity with quality documentation, batch record review, SOP development, and document control systems.
• Experience supporting internal audits, supplier audits, and regulatory inspections.
• Strong analytical, problem‑solving, technical documentation, and organizational skills.
• Excellent communication and cross‑functional collaboration skills with the ability to work effectively in a regulated environment.
• Experience working within pharmaceutical, biotechnology, or medical device manufacturing facilities is highly preferred.
• Knowledge of statistical quality tools, risk management methodologies, Lean Manufacturing, or Six Sigma is an added advantage.