The Quality Management System Specialist executes daily activities and maintains focus on the Change Control, CAPA and Risk Management systems. This position ensures compliance with established and approved quality systems.
Maintains current procedures and executes quality functions within the Change Control, CAPA, Calibration, Document Control and Risk Management processes.
Maintains and distributes quality system metrics following established procedures.
Reviews change control, CAPA, document change controls, calibration and other quality records for accuracy and conformance to established guidelines, and procedures.
Follows impact to associated documents and prompts update by SMEs.
Performs data entries as required to maintain the process.
Advises and responds to queries on quality systems.
Coordinates changes to the applicable Quality System procedures by reviewing changes for applicability, interfacing with internal approval SMEs and management, facilitating functional meetings, and acting as a liaison to bring documentation to closure.
Identifies improvements by analyzing the current business/system processes and recommending improvements within the scope of their influence.
Reviews quality system information for accuracy and conformance to established guidelines and procedures.
Records and follows-up on all quality system entries.
Reviews and approves calibration, preventative maintenance records and work orders.
Completes Quality Impact Assessments for document change controls (DCC).
Bachelor’s degree in science or equivalent is required; Biology/Chemistry preferred, with 1-3 years of experience in the biotechnology, pharmaceutical, (GxP) industry; or equivalent combination of education and experience.
Experience in Quality Assurance functions and Quality Compliance functions strongly preferred.
Excellent written and verbal communication skills required, including responsible business communication.
Scientific writing experience preferred.
Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
Strong customer service philosophy required.
Must be proficient with all MS Office applications.