What are the responsibilities and job description for the Specialist Quality Assurance position at The Steely Group?
Responsibilities :
Supporting the product complaint system through triage of product complaints and management of Level I complaint processing and closure in adherence with complaint policies and procedures, while assuring compliance to federal regulations.
Candidate will be responsible for; ensuring complaints are accurately entered into the complaints database in a timely manner, triaging complaints to determine complaint code and investigation level, determining whether the complaint is associated with an adverse event or medical device, documentation of follow-up communication to complainants for additional information or complaint sample returns, re-assigning complaints to the appropriate investigation site, closing complaints per required timeframes and providing responses to the complainant.
Candidate will also be responsible for working with other departments, contract partners and call centers to resolve discrepancies / deficiencies.
Additional responsibilities include prioritizing complaints and understanding the importance of accurate data entry of complaints within the required timeframe, notifying appropriate parties upon receipt of complaints, supporting the complaints returns process by determining follow-up required for complaint return samples and documentation of communication attempts, partnering with call centers providing tactical oversight and support, providing written communication to senior management and team members, and performing other duties as assigned by supervisor. Requirements / Qualifications :
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Project management skills including detailed note taking, planning and scheduling meetings and / or workshops, presentation creation, metric analysis and reporting
Excellent written and verbal communication skills in English and Spanish.
Excellent verbal diction and ample vocabulary is necessary as Specialist will interact with patients to obtain additional information on reported events and sample returns.
Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.
Computer literacy, independently understand, follow and implement instructions, work independently or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions and determine when to escalate, as necessary.
Candidate must possess outstanding attention to detail and organization skills, effective decision making skills, focus on process improvements, and ability to manage a large number of complex projects simultaneously Preferred Qualifications :
5 years of biopharmaceutical experience responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
Understanding of biopharmaceutical bulk and drug product manufacturing and distribution processes.
General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture, testing and distribution of biopharmaceuticals.
Masters degree preferred.
The candidate must be self-motivated, able to interface effectively with various levels, have careful attention to details and an understanding that accuracy and precision in all aspects of work are necessary.
Candidate must be able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, and customer service skills to operate and deliver results in a matrix-managed GMP environment.
Candidate must be well-organized, possess excellent oral and written communication skills, focus on process improvements, possess ability to manage a large number of complex projects simultaneously, and have the ability to function in a fast paced environment.
Candidate must possess the ability to evaluate issues, make quality decisions and understand when to escalate, if necessary.
