General Summary
The Quality Control (QC) Group works to ensure the integrity and quality of study results by providing data and documentation review at critical points during a study. Quality Control 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. The Quality Control Inspector may provide guidance on current and new processes with the Quality Management System regarding various methods of data collection.
Essential Duties & Responsibilities
- Trained on Principles of Good Laboratory Practices (GLP), keeps current on required training, and understands and applies knowledge of regulations in daily work.
- Reads and keeps current on all assigned standard operating procedures (SOPs).
- 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.
- Reviews data and documentation within laboratory information management systems (LIMS) when applicable (e.g., Provantis).
- Communicates review observations with responsible scientific team members following an established process flow.
- Verifies corrections once made.
- Ensures chain of custody is maintained for paper documentation going between QC and scientific or laboratory staff. May file paperwork in Data Room.
- 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.
- May review draft reports for completeness and accuracy.
- Manages assigned workload with some to minimal assistance from coworkers and supervisor.
- Records observation types for tracking purposes. Tracks trends in error observations in order to compile and distribute monthly metrics.
- Report workload errors, totals and metrics for QC.
- May provide training support for standard operating procedures relating to records management.
- Conducts trainings for QC processes to internal personnel
- Participates in QC team meetings and collaborates with team members to improve quality systems in the division.
- Provides estimates for QC labor hours
- Performs other duties as may be required by the supervisor.
Requirements/Minimum Qualifications
- Education and Experience
- HS diploma or equivalent and 10 years of related experience; or
- Associate degree and 5 years of related experience; or
- Bachelor's degree in a related field with 2 years of related experience
- A minimum of 1 year of experience working in a regulated environment where SOPs and regulations (e.g., GLP, GMP, ISO) inform daily work
- Effective verbal and written communication skills, including correct spelling, grammar, and punctuation
- High degree of attention to detail
- Problem solving and critical thinking skills
- Excellent organizational, planning, and time management skill
- Ability to work both independently and collaboratively as a team member, handling multiple priorities
- Proficiency with Windows-based Microsoft Word and Excel
Preferred Qualifications
- Experience with animal lab data and familiarity with data collection software (ex: Provantis or Benchling)
- Prior exposure to multiple types of datasets (ex: PCR, ELISA, TCID50, MN, etc.)
- High degree of understanding of Excel and formulas associated with data calculations
Core Values
Cultivating human connection - putting people first. We know that every individual makes a difference and that no one can do it alone. We believe the world's most powerful resource is human potential. We are an inclusive and courageous team where innovation and diversity of though go hand in hand. We understand that relationships move at the speed of trust.
Operating with precise execution - measuring what matters and owning results as a team. We leverage data to drive decisions that advance science. We recognize the importance of a stable foundation coupled with an agile mindset. We hold ourselves accountable and take pride in our work. We give and receive candid feedback as a gift that keeps us growing.
Harnessing relentless curiosity - our unstoppable, innovative force. We are driven to ask sharp questions and push the boundaries of knowledge. We use creativity and critical thinking as catalysts for finding solutions that change lives. We learn by doing, consistently striving to improve our relationships, training, methodologies, questions and results.
Stewarding a healthy community - implementing sustainable operations for a safe, engaging environment. We don't compromise on safety and health for our employees, customers or community. We believe a healthy community begins with inclusive economic opportunities. We respect the dignity of the patients we ultimately serve. We are motivated to serve communities that are underserved and markets that are overlooked.
Job Specific Behaviors
Relationship Orientation - Develops positive relationships by making others feel their concerns and contributions are important.
Continuous Learning - Proactively seeks performance feedback and identifies approaches to improve personal and others performance and learning.
Tolerance for Stress, Ambiguity & Change - Demonstrates flexibility in applying different approaches to changing work demands.
Effective Communication - Creates a team environment in which information flows freely and decision making is based on a win-win philosophy.
Compliance - Applies an understanding of key legal precedents, policies, and practices to protect the interests of the organization.
Cross-team Collaboration - Ensures integration and cooperation across organizational boundaries.
Attention to detail - Utilizes established monitoring system, records data accurately and in a timely manner, and ensures accuracy of data.
Planning and Organization - Systematically identifies issues to be addressed and helps plan a course of action for self and others to ensure the accomplishment of specific objectives.
Operational / Technical Excellence - Ensures that work product (whether service or process) enables the organization to deliver on customer's expectations.
Physical Demands
- Ability to perform work utilizing a computer for extended periods of time.
- Ability to sit for extended periods of time without being able to leave the work area.
Certifications, Licenses & Registrations
None required