Lead QC Associate - Incoming

Responsibilities

• Provide leadership and guidance for the Incoming inspection team, including scheduling and coordinating inspections.
• Inspect incoming materials, components, and finished products against specified requirements.
• Perform testing on materials such as labels, cartons, syringes, and containers using measuring equipment.
• Document all results in compliance with cGMP, ALCOA+, and data integrity policies.
• Review Certificates of Analysis (COAs) for APIs and excipients to ensure compliance prior to material release.
• Prioritize daily tasks and communicate with the planning team regarding material needs and timelines.
• Manage material status in the ERP system, including placing items on hold for deviations or expiration.
• Act as a Subject Matter Expert (SME) for investigations involving QC Incoming activities.
• Support continuous improvement initiatives to streamline inspection and documentation processes.

Requirements

• High school diploma or GED required.
• 5+ years of experience in a quality-related capacity.
• Working knowledge of drug or device cGMP.
• Proficiency with MS Office (Word, Excel, and Access).
• Ability to lift a minimum of 30 pounds.
• Proficiency in color vision to support inspection tasks.
• Ability to pass a physical and eye exam.

Preferred Qualifications

• Associate’s degree or college-level coursework.
• Experience in a high-volume manufacturing or laboratory environment.
• Previous experience within the pharmaceutical or medical device industry.

About the Company

Tolmar is a pharmaceutical company dedicated to improving patient lives through high-quality products. We operate with core values centered on people, proactive engagement, ethical conduct, continuous improvement, and accountability.