Assistant Quality Control Inspector

ASSISTANT QUALITY CONTROL INSPECTOR
General Summary
The Quality Control (QC) Group in the CRO Services Division works to ensure the integrity and quality of study results by providing data and documentation review at critical points during a study. The Assistant QC Inspector reviews data for any deviations from applicable specifications and documentation for completeness and accuracy, and communicates any observations to the responsible scientific, laboratory, or facilities staff.
Essential Duties & Responsibilities

• Reads and keeps current on all assigned standard operating procedures (SOPs).
• Trained on Principles of Good Laboratory Practices (GLP), keeps current on required training, and understands and applies knowledge of regulations in daily work.
• May review draft reports for completeness and accuracy.
• Training support for standard operating procedures relating to records management.
• Ensures chain of custody is maintained for paper documentation going between QC and scientific or laboratory staff. Files paperwork in Data Room.
• Communicates review observations with responsible scientific team members following an established process flow.
• Participates in QC team meetings and collaborates with team members to improve quality systems in the division.
• Conducts trainings for QC processes to internal personnel
• Verifies corrections once made.
• Records observation types for tracking purposes.
• Report workload errors, totals and metrics for QC.
• Manages assigned workload with some to minimal assistance from coworkers and supervisor, depending on length of training.
• Reviews study data for correctness and completeness, including mathematical calculations, equipment and materials verification, and adherence to applicable regulations (e.g., GLP), the study protocol, SOPs, and other study- or customer-specific specifications.
• Performs other duties as may be required by the supervisor.
• On a timely basis reviews data in accordance with project time lines. Keeps abreast of assigned study schedules and adapts when schedules change. May attend divisional scheduling meetings.
• Provides estimates for QC labor hours
• Reviews data and documentation within laboratory information management systems (LIMS) when applicable (e.g., Provantis, Watson).

Requirements/Minimum Qualifications

• Ability to work both independently and collaboratively as a team member, handling multiple priorities
• Proficiency with Windows-based Microsoft Word and Excel
• Effective verbal and written communication skills, including correct spelling, grammar, and punctuation
• Excellent organizational, planning, and time management skill
• Education and Experience
• Problem solving and critical thinking skills
• A minimum of 1 year of experience working in a laboratory setting, preferably a regulated laboratory where SOPs and regulations (e.g., GLP, GMP, ISO) inform daily work
• Bachelor's degree in a related field
• Associate degree and 4 years of related experience; or
• High degree of attention to detail
• HS diploma or equivalent and 7 years of related experience; or

Physical Demands

• Ability to sit for extended periods of time without being able to leave the work area.
• Ability to perform work utilizing a computer for extended periods of time.

Certifications, Licenses & Registrations
None required