Performs a variety of chemical, biological, or physical analyses on quality control samples in support of the company’s quality program. Works as part of the site quality control function, focusing on method and testing process improvements. Serves as local QC representative for cross-functional and inter-facility projects. Trains and leads others within the laboratory.
- Performs and reviews advanced biological and chemical assays
- Maintains knowledge of instrument, software, and documentation for repair and calibration of instrument systems
- Provides training and work direction and serves as a mentor to other Quality Laboratory Associate positions
- Conducts method remediation/improvements and serves as method introduction representative for local QC
- Works to bring best practices to the site (e.g. securing controls, implementing testing and maintenance strategies, etc).
- Leads corporate and regulatory audits as required
- Completes corrective actions from audits, non-conformances, LIRs, etc.
- Works on special projects involving new methods and instrumentation including validations, feasibility studies, and development work
- Keeps up to date on industry standards for QC testing
- Reviews method development protocols and summary reports
- Leads and participates in continuous improvement initiatives, using DMAIC/Blue Belt principles to generate solutions for QC issues
- Interfaces with functional representatives at the site level (Production, Tech Ops, etc) as part of production problem solving teams
- Prepares, reviews and revises, as required, protocols, SOPs and CTPs.
- Recommends instrument purchases and upgrades for the laboratory that ensures optimum lab performance.
- Troubleshoots and resolves instrument problems
- Writes Level I and Level II non-conformance reports, laboratory investigation reports, and control chart investigation reports as needed
Strong team player and willingness to help others when needed. Communicates effectively in both written and verbal modes. Openly shares information, listens to and values feedback, shares opinions and feedback directly. Strong leadership, organizational, and time management skills. Demonstrated effectiveness in ability to train others, empowerment, leadership, results orientation, and task completion. Decision making and technical problem solving abilities. Ability to lead projects with minimal supervision. Strong computer skills and organizational skills.
BS in Chemistry, Biochemistry, or related field with a minimum of 10 years pharmaceutical laboratory experience or a Masters in Science degree in Chemistry or Biochemistry, with 5-8 years of experience.
Location/Region: Social Circle, GA