Quality Control Associate

Role Summary

The Quality Control Associate will provide quality support by means of thorough review of data collected and generated within the laboratory. Additionally, the Quality Control Associate will be responsible for compiling data from various source documents, completing data tabulation, reviewing raw data and results from studies, reviewing equipment records, and preparing departmental records for archival, annually.

This is a non-exempt role that is eligible for overtime after 40 hours in a work week and has no supervisory responsibilities.

Role Responsibilities

• Ensure data collected meets or exceed industry standards of accuracy and GLP requirements
• Evaluating collected data for accuracy and compliance with methods, SOPs, GLPs, and Protocols
• Accurately identify and communicate findings. Assist in resolving issues with data as they arise.
• Compilation of study data tables in collaboration with Data Coordinators and laboratory staff
• Collect and prepare source documents for data entry, including accuracy checks, verifying, and correcting tables, and locating information when the data is incomplete. Interaction with research associates and scientists, as needed.
• Compilation and tabulation of data. Facilitating laboratory staff in completing table sets in a timely, efficient, and accurate manner.
• Transcribe data into the required electronic format, as needed
• Understand and comply with data integrity and security policies and procedures.
• Assist in addressing Quality Assurance audit findings related to data tables
• Compilation and the appropriate review of study books and departmental records prior to annual archival.
• Other duties as assigned

Role Requirements

• Bachelor’s degree or equivalent in a related discipline.
• 2 years of experience in a GLP-compliant laboratory is required
• Laboratory experience is preferred
• Ability to learn and use novel software applications.
• Good written and oral communication skills.
• Ability to work independently under specific time constraints.
• Expertise with Microsoft Office core applications and the ability to learn and use additional
  applications.
• Knowledge of GLPs and other federal regulations related to reporting.
• Excellent understanding of study design and protocols.
• Advanced understanding of laboratory operations and data collection.

Behavioral Expectations

• Collaboration/Teamwork
• Flexibility
• Attention-to-detail

Special Requirements

• Physical Requirements: Ability to lift and carry up to 25 lbs.
• Ability to spend 100% of the time in an office setting using a computer.
• May occasionally be required to work extended hours beyond normal work schedule.