The Specialist Quality Complaints role primary responsibilities include : Owning investigations and supporting the product complaint system at Amgen through thorough and detailed manufacturing, process and distribution evaluation, to ensure in adherence with Amgen Complaint policies and procedures, while assuring compliance to federal regulations.
SPECIFIC RESPONSABILITIES INCLUDE BUT ARE NOT LIMITED TO :
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.
Responsible for working with other Amgen 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.
Master's degree and 3 years of experience in GMP environment
Bachelor's degree and 5 years of experience in GMP environment
Educational background in in Life Sciences or Engineering
Experience managing NCs , Complaints, Root Cause Analysis .
Able to communicate at all levels of the organization; excellent presentation skills.
Able to work based on priorities and manage trade-offs effectively
Manage conflicts in an effective manner.
Experience working in a network environment. Demonstrate OPEX experience.
Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously.
Excellent written and verbal communication skills in English and Spanish.
Excellent communications skills 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
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.
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.
Biopharmaceutical experience responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
Understanding of biopharmaceutical bulk and drug product, solid dosage and combination products manufacturing and distribution processes.
General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture, testing and distribution of biopharmaceuticals.
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.
Able to prioritize and meet deadlines, and possess excellent leadership, problem solving, analytical, and customer service skills to operate and deliver results in a matrix-
managed GMP environment.
Well-organized, 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.
Ability to evaluate issues, make quality decisions and understand when to escalate, if necessary.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.