associate ii, quality control - sample management

$41,600 - $73,050/Yr

Randstad - Norwood, MA

Full-time - Entry Level

Norwood, MA

Administrative and Support Services

About the position

The Associate II, Quality Control - Sample Management position is a contract role focused on performing cGMP QC sample management activities across various laboratories. The role involves coordinating sample management tasks, ensuring compliance with quality control standards, and supporting laboratory operations in a dynamic environment. The position is integral to maintaining the quality and safety of products in the life sciences sector.

Responsibilities

• Perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay, and various Development labs.
• Coordinate sample management including collaboration with internal and external labs.
• Handle receipt, processing, distribution, and shipment of various sample types such as In-Process, DS, Formulation, and DP.
• Conduct equipment cleaning and stability testing.
• Manage domestic and international sample shipments.
• Communicate with external Contract Test Labs (CTLs).
• Interact with Development teams in a GMP compliant manner.
• Inspect product and raw material retention samples.
• Log samples and enter results in LIMS (LabVantage).
• Perform AQL visual inspection of drug products.
• Support stability programs and manage controlled temperature units.
• Maintain and stock QC lab supplies.
• Write and revise SOPs, protocols, and reports.
• Complete and maintain cGMP documentation for work performed.
• Participate in authoring quality systems records such as deviations, change controls, and CAPAs.
• Support non-conformance investigations and establish a safe laboratory working environment.

Requirements

• Bachelor's degree in a relevant scientific discipline.
• At least two years of experience in a cGMP laboratory setting.
• Demonstrated aptitude or ability to learn GxP regulations.
• General laboratory operations experience, including pipette and analytical balance use.
• Strong technical writing skills and proficiency with Microsoft Office Programs.
• Ability to learn electronic databases (e.g., LIMS, SAP, LMS).
• Strong written and oral communication skills, along with organizational skills.
• General knowledge of industry standards and guidelines for quality control laboratory operations.
• Ability to work effectively under established guidelines and instructions.
• Collaborative skills in a dynamic, cross-functional matrix environment.
• Ability to follow Standard Operating Procedures as written.
• Efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.

Nice-to-haves

• Experience with quality control processes in the life sciences sector.
• Familiarity with laboratory safety protocols and practices.

Benefits

• Health insurance
• Incentive and recognition program
• 401K contribution