Assist with integration and support of quality regulations: drug, biologics, device and/or combination products. Assist in the design of effective Laboratory Control Quality System, procedures and/or process within cross functional teams to ensure compliance as well as efficiency.
- Perform analytical test methods as written and perform data verification of laboratory results to support product release without error.
- Understand laboratory techniques and principles performed and can independently troubleshoot and resolve analytical techniques and instrument issues. Implement and ensure improvement ideas are completed to facilitate team objectives.
- Ability to work in multiple laboratory functional areas as assigned and can effectively perform a multitude of laboratory techniques for which trained on with mínimal error while adjusting to unforeseen technical or logístical obstacles to accomplish assignments.
- Budget time effectively to complete assigned tasks and make recommendations for improvement. Take initiative to be involved in team activities and decision making.
- Maintain training requirements and certifications as needed for assigned job tasks and take responsibility to add new training diversification to meet broader team objectives.
- Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements. Support internal and external quality inspections and audits.
- Represent affiliate QC in regional, global and cross functional teams, projects and programs, as assigned by management.
- Bachelor's Degree in Chemistry, Biochemistry, Medical Technology, Biology or equivalent science degree.
- 4+ years' of laboratory experience.
- Ability to work with general supervision with effective management of own time to multi task based upon training matrix.
- Accountable to supervisor/manager and assigned team to meet broader business objectives.
- Demonstrated strong analytical skills and logical thought process.
- Knowledge of applicable regulations, quality systems and principles of quality assurance.
- Knowledge and familiarity with product, process, and both internal and external customer requirements.
- Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred.
- Demonstrated strong laboratory skills and abilities. Strong computer skills and knowledge of enterprise systems such as SolTraqs, Attache, Attache Pro and various laboratory systems. Strong oral and written communication skills needed. Excellent interpersonal skills and problem solving skills.