The Quality Management System Specialist executes daily activities and maintains focuses 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/Risk Management processes.
Reviews change control information for accuracy and conformance to established guidelines, and procedures.
Follow impacts to associated documents and prompt 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.
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; experience a plus.
Must be proficient with all MS Office applications.
• Environment: Work is performed in Manufacturing, GMP Warehouse, and office settings. Exposed to chemotherapeutic agents, in addition to a variety of hazardous and cytotoxic chemicals found in a bench lab setting. Potential exposure to human blood, serum, and tissues.
• Physical: Primary functions require sufficient physical ability to work in an office setting and operate standard office equipment including use of a computer keyboard. Light work, which includes exerting up to 20 lbs. of force occasionally and/or up to 10 lbs. of force frequently to move objects. Physical demands are in excess of those of sedentary work. Light work usually requires walking or standing to a significant degree.
• Vision: Need to pass 20/20 near focus visual acuity test (with or without correction) and be able to read font size 3 vial labels. Otherwise, needs to see in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents.
• Hearing: Hear in the normal audio range with or without correction.