The QC Compliance Specialist responsible for supporting compliance in Quality Control, including investigation/deviation management, CAPA tracking, and change control. This position will facilitate the compiling, trending and reporting key quality metrics for management, and other quality control functions, as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.
- Supports and ensures timely initiation, write up and closure of QC CAPAs, Investigations, Deviations and Change Controls.
- Responsible for tracking and trending aspects of Quality Control Systems and provide reports to management identifying risks and trends on a routine basis.
- Works with Quality Systems group to perform QC CAPA effectiveness evaluation based on quantitative and qualitative measurements.
- Maintains tracking mechanisms to support various QC related metrics.
- Continuously monitor and review QC systems and procedures for adherence to regulatory compliance, quality improvements, efficiency and industry best practices. Provide compliance support and expertise for QC department.
- Participate in QC compliance remediation plans and implementation.
- Assists with the generation and/or revision of GMP documentation such as standard operating procedures.
- Establish and execute laboratory housekeeping activities to ensure a compliance ready state in the laboratory.
- Participates in QC internal audits as applicable.
- Participate in site quality and process improvement initiatives. Represent QC on site project teams.
Education & Experience:
- Minimum of a B.S. in a Life Sciences discipline
- 8 years' experience in a Quality Compliance role with at least 2 of those years supporting GMP biologics manufacturing processes
- Have the knowledge, and ability to apply basic scientific and regulatory principles to improve quality systems
- Experience working in electronic systems such as LIMS, EDMS, ERP desirable