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Quality Control Technician I – QC Lab Support

United States - Maryland - FrederickQualityRegular

Descripción del trabajo

Key Responsibilities

(Include, but are not limited to):

  • Receive incoming samples, verify accompanying documentation, and accurately log sample information into the Laboratory Information Management System (LIMS).
  • Execute processes supporting sample receipt, processing, and aliquoting for release testing, stability programs, and retain samples.
  • Label, store, and organize samples in accordance with approved procedures, storage conditions, and retention requirements.
  • Coordinate and manage sample transfers and shipments to internal and external testing laboratories.
  • Perform routine cleaning, maintenance, and restocking of sample storage and laboratory support areas.
  • Collaborate with Manufacturing, Quality Assurance (QA), and Quality Control (QC) teams—including Corporate QC—to support sampling, testing, and disposition activities.
  • Manage and complete all QC-related shipping activities, ensuring compliance with safety, quality, and regulatory requirements.
  • Perform routine review of documentation, including chain-of-custody forms, processing logs, logbooks, and other QC Lab Support records.
  • Assist with deviation investigations and related documentation, as needed.
  • Provide status updates and communicate issues during daily huddles and weekly meetings.
  • Participate in Lean Lab, Operational Excellence, and continuous improvement initiatives.
  • Comply with all safety, quality, and regulatory guidelines, including GMP requirements.
  • Perform other duties as assigned to support QC operations.

Basic Qualifications

  • Bachelor’s degree, OR
  • Associate’s degree (AA) with 2+ years of experience working in Quality Control or biopharma laboratories, preferably in an FDA‑regulated environment, OR
  • High School diploma with 3+ years of experience working in Quality Control or biopharma laboratories, preferably in an FDA‑regulated environment.

Preferred Qualifications

  • Strong working knowledge of GMP requirements as applied to QC laboratory operations.
  • Exceptional attention to detail with the ability to track and manage multiple concurrent activities and priorities.
  • Proficiency in Microsoft Office, including Excel and Visio, and related business applications.
  • Excellent verbal and written communication skills, with the ability to collaborate effectively in a team-based environment.
  • Comfortable working in a fast‑paced, small company or growth‑oriented environment, with the ability to adjust workload based on changing priorities.
  • Flexibility to adjust work schedules and work overtime as business needs require.