Customer Quality Specialist II

Overview

Adecco is currently seeking a Quality Specialist II in Rochester, NY. The Customer Quality Specialist II is responsible for leading and supporting product investigations, change controls, and final release activities in a regulated environment. This role manages the intake, investigation, and resolution of product complaints, ensuring all complaints are handled in compliance with company procedures and applicable regulations.

This position serves as a key quality representative, working cross-functionally and interacting regularly with customers’ Quality Assurance teams. The Customer Quality Specialist II reviews and approves GMP documentation, provides quality guidance across departments, and communicates effectively with leadership to drive timely, compliant, and effective quality outcomes.

• Investigations & CAPA Management:
  Lead, review, and approve problem investigations (deviations) and change controls, ensuring investigations contain appropriate depth, accuracy, and documentation.
• Receive and investigate product complaints, including review of batch records, retains, deviations, and other relevant data.
• Identify and engage appropriate cross-functional resources to support thorough investigations.
• Partner with relevant disciplines to define and implement corrective and preventive actions (CAPAs).
• Compile and finalize investigation documentation, ensuring clear conclusions and proper system closure.
• Prepare and provide accurate, timely responses to customers regarding complaint outcomes.

• Trend Analysis & Reporting:
  Analyze complaint data to identify trends and systemic issues.
• Support Annual Product Reviews (APR) by providing timely and accurate complaint analyses in accordance with site procedures.

• Process Improvement & Efficiency:
  Develop, document, and implement standardized quality processes.
• Evaluate SOP effectiveness and drive improvements through change control.
• Identify opportunities to streamline workflows while maintaining compliance and quality.
• Apply regulatory knowledge and industry trends to enhance process performance.
• Leverage available technology to improve efficiency and data integrity.
• Ensure stakeholders are trained on new or updated processes.
• Quality Guidance & Leadership:
  Maintain current knowledge of applicable regulations and internal procedures.
• Provide quality leadership, technical expertise, and compliance guidance across the organization.
• Support or lead continuous improvement initiatives related to quality systems.

• Bachelor’s degree in Chemistry, Biology, Pharmacy, Health Science, or a related field.
• Minimum of 5 years of Quality Assurance experience in an FDA-regulated environment preferred.
• Degree requirement may be substituted with 8–10 years of equivalent Quality Assurance experience in an FDA-regulated environment.

• Strong understanding of FDA regulations and quality system requirements.
• Ability to interpret and apply regulatory standards effectively.
• Excellent collaboration, communication, and project management skills.
• Strong problem-solving skills with the ability to assess impact to product quality, safety, identity, and purity.

• Exercises judgment within established procedures and guidelines.
• Individual contributor role with no direct supervisory responsibilities.

• Office-based role with frequent presence in production, laboratory, and warehouse areas.
• Prolonged computer use required.
• PPE required in designated areas.
• Approximate work distribution: 75% sitting, 25% standing or walking.

Click apply to be considered for this Customer Quality Specialist II opportunity in Rochester, NY!

Pay Details: $40.00 to $60.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid…