Quality Assurance Specialist

Actylis•Town of Grand Island, NY

13d•Hybrid

About The Position

Actylis is a global solutions provider with over 75 years of experience, specializing in streamlining the management of critical ingredients and raw materials for our business partners. We offer both sourcing and manufacturing solutions tailored to meet diverse and evolving needs, ensuring a reliable, agile, and secure supply network. Our commitment to customization allows us to create flexible solutions, whether it’s a unique specification, custom packaging, or tailored logistics strategies. With deep expertise in quality and regulatory compliance, sourcing and logistics management, analytical services, and R&D support, we reduce complexities and mitigate risks, empowering our partners to focus on growing their business. In furtherance of that goal, Actylis is seeking new members of the team. This expansion, coupled with a comprehensive benefits package, and opportunities for challenge and growth, make Actylis the ideal place to work and thrive. We hope you’ll consider joining us! Position SummaryThe Quality Assurance Specialist supports all quality-related activities under the supervision of Quality Leader, ensuring compliance with quality standards, regulatory requirements, and Good Manufacturing Practices (GMP) in a manufacturing environment. This role is responsible for monitoring production processes, conducting quality inspections, and working closely with cross-functional teams to maintain and improve product quality.

Requirements

Bachelor’s degree in (e.g., Biology, Chemistry, Engineering, or related discipline), or technical degree in related field.
3+ years of experience in a quality assurance role within a manufacturing environment, preferably in chemical industry, pharmaceuticals, medical devices, or food industries.
Proficiency with Microsoft suite

Nice To Haves

Strong knowledge of GMP, ISO, and regulatory requirements
Experience with quality systems, CAPA, root cause analysis, and auditing
Knowledge of Quality Management Systems such as Master Control preferred
Strong problem solving and facilitation skills.
Ability to quickly prioritize projects & workload.
Comfortable working in a fast-paced cross-functional team.
Must be detail-oriented and organized, able to work both independently and as a team player.
Effectively communicate with peers and interdepartmental colleagues

Responsibilities

Oversee manufacturing processes to ensure adherence to quality and compliance standards and meet customer requirements. This includes maintaining floor presence to interact with production staff and leadership.
Participate and/or coordinate the corrective action process, including root cause analysis and proper closure in MasterControl.
Perform in-process inspections and review batch records to verify conformance to specification.
Attend GEMBA walks to observe processes, identify opportunities for improvement, and engage with frontline teams to drive operational excellence.
Facilitate pre-and-post campaign Quality review meetings with project leaders, shift leaders and departmental staff to support preparation and identification of opportunities for improvement.
Facilitate and/or participate in management review meetings with senior management.
Support all quality related functions within company MRP system (SAGE) such as CoA, raw material approval, etc.
Manage the approved supplier process and monitor performance.
Facilitate and/or participate in weekly QC meetings with project leaders, shift leaders or department staff.
Work collaboratively with production, engineering, and supply chain teams to resolve quality issues.
Interface with customers on quality related issues.
Work with appropriate leaders to ensure staff receive proper training and appropriate documentation is completed.
Coordinate Ethics and Integrity training for all staff.