Quality Laboratory Systems Specialist

Responsibilities

• Utilize and develop phase and systems audit programs for internal laboratory functions and external suppliers in direct support of 21 CFR Part 58, ISO 17025, and the overall Quality System.
• Support the development, implementation, and maintenance of various aspects of the client CPDT Quality System, including creating and reviewing documents such as SOPs, Procedures, Methods, and Protocols.
• Participate in the development and implementation of the client CPDT Training System to ensure training is performed and documented for compliance with Quality System and regulatory requirements.
• Maintain the client CPDT Document Control system for all controlled documents, including Policies, Protocols, Reports, and Standard Operating Procedures.
• Accompany representatives from sponsoring organizations or government regulatory agencies during site audits.
• Provide GLP, ISO, and Quality System training.
• Manage the Master Schedule.
• Backup for the client CPDT GLP Archives for all controlled records, documents, and samples.
• Assist with the Metrology program, including maintenance of the Regulatory Asset Manager System.
• Manage the supplier audit and approval system, including setting audit dates with suppliers and performing audits.
• Collaborate with managers, scientists, and Quality Assurance personnel to develop process improvements in order to enhance testing and workflow efficiency.
• Maintain an environment of continuous improvement and quality aligned with client core values and strategic objectives.

Qualifications

• Data review of laboratory data, especially related to HPLC, LCMS, GCMS, ICPMS instrumentation (analytical equipment).
• Experience in data review related to HPLC, LCMS, GCMS, ICPMS instrumentation (analytical equipment).
• Peer review experience in the above instrumentation may be considered.