Quality Assurance Specialist

Job Title: Quality Assurance Specialist

Work Location: Erie County, New York

Summary:

The Quality Assurance Specialist is responsible for overseeing manufacturing processes to ensure compliance with quality standards, supporting continuous improvement initiatives, and collaborating with cross-functional teams to resolve quality issues.

Responsibilities:

• Monitor manufacturing operations to ensure compliance with quality standards and interact with production staff to address issues.
• Coordinate and participate in corrective action processes, including root cause analysis and closure activities.
• Conduct in-process inspections and review batch records to confirm adherence to specifications.
• Engage in process observation walks to identify improvement opportunities and promote operational excellence.
• Lead or participate in quality review meetings with project and shift leaders to support campaign preparation and improvement identification.
• Support quality-related functions within the MRP system, including raw material approval and certificate of analysis management.
• Manage the approved supplier process and monitor supplier performance for compliance.
• Collaborate with production, engineering, and supply chain teams to resolve quality issues and facilitate staff training and documentation.

Qualifications:

• Bachelor’s degree in Biology, Chemistry, Engineering, or a related discipline, or a technical degree in a related field.
• 3+ years of experience in a quality assurance role within a manufacturing environment, preferably in chemical, pharmaceutical, medical device, or food industries.
• Strong knowledge of GMP, ISO, and regulatory requirements.
• Experience with quality systems, CAPA, root cause analysis, and auditing.
• Familiarity with Quality Management Systems such as Master Control is preferred.
• Excellent problem-solving and facilitation skills.
• Ability to prioritize projects and manage workload efficiently.
• Detail-oriented, organized, and able to work independently or as part of a team.
• Effective communication skills with peers and interdepartmental colleagues.
• Proficiency with Microsoft Office suite.

Published Category: Quality & Validation