- Provide Quality Control (QC) documentation support to operations.
- Perform QC review of documentation such as Sample Login binders, run binders, extraction paperwork, Lab notebooks, Data tables, and reports Participate in review of technical and QC SOPs to ensure compliance with appropriate regulations.
- Actively participate in QC educational programs: in-house workshops, presentations on current QC issues, QC training and QC Seminars for all new employees, etc.
- Participate in QC and company staff meetings and discuss findings and recommendations for resolving non-compliance.
- Work in conjunction with operation individuals to improve quality systems.
- Manage and schedule all assigned quality control projects with minor assistance from coworkers and manager.
- May track and report deviation trends to management.
- Evaluate all systems for gaps, recommend actions and professionally communicate to management the analysis to continually improve quality.
- Demonstrate continuous self-motivated quality development.
- Proactively take steps to improve quality systems.
Minimum required education and experience
- Bachelor’s Degree required
- Equivalent combination of education, training and experience may be substituted for degree
Required knowledge, skills and abilities
- Laboratory experience in a GLP environment.
- Knowledge of word-processing, spreadsheet, and database applications.
- Knowledge of GLP regulations and guidelines and basic quality review techniques..
- Strong interpersonal skills.
- Excellent problem solving skills.
- Effective organization, communication, and team orientation skills.
- Ability to initiate assigned tasks and to work independently.
- Ability to manage multiple projects.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.