QC Specialist

Job description:

• Perform routine QC laboratory (Microbiology, Wet Chemistry, or Chromatography) to support the manufacture and release of products and incoming materials. Understand test equipment and scientific principles of methods within the scope of their responsibility.

Key responsibilities:

• Perform sampling and testing following written methodologies and report results which are clear, defensible and right the first time.
• Demonstrate awareness of the scientific principles and method validation for the assays which they perform.
• Review GMP assay data and communicate findings to manufacturing teams.
• Prioritize and decide appropriate course of action with minimal supervision. Participate in lab investigations and problem solving.
• Support non-routine tests, studies or projects. Support the qualification, operation and scheduled maintenance of laboratory equipment, including automated and computerized systems and assure they remain in a functional, validated state. Escalate issues associated with equipment and assays as required.
• Understand and comply with current GMP regulations and quality systems. Promotes a quality mindset in every action, every day by routinely communicating concerns, issues and best practices.
• Accountable for supporting QC and site operations, communicating in a positive, professional manner, supporting operational excellence principles and supporting and implementing management decisions.
• Performs other departmental duties as assigned by management.
• Responsible for application of CLIENT safety and environmental guidelines and identification, escalation and prevention of safety issues. Duties may include minimal handling of hazardous waste from laboratory activities to satellite storage areas.
• Assist in maintaining area of responsibility in a state of inspection readiness.

Minimum Education Required: No experience required

Other requirements:

• Specialist must have scientific education to understand testing concepts and principles, mathematical calculations and application of both.
• Computer skills and knowledge; basic proficiency with Microsoft Office programs.
• Demonstrated ability to work successfully both independently and in a team environment.
• Good verbal and written communication skills.
• Good time management skills.
• Position may require the employee to work shifts, holidays, and/or weekends. Ability to work in manufacturing, lab, and open office environments.