Quality Assurance Specialist
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives. Our success is powered by our world-class team's commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world's fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn't just welcomed, it's encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
Position Description
Under general supervision, oversees the completion and accuracy of any of the following; preparation, negotiation, and maintenance of quality agreements, management of centralized electronic repository for quality agreements, generation of metrics reports, management of supplier change notifications and change controls, and approved supplier list management.
Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
Preparation of new quality agreements with various Allergan suppliers.
Updates and maintains existing quality agreements.
Maintains global quality agreement repository. Filing of all quality agreements in the repository.
Contributes in the generation and maintenance of quality agreement templates and procedures.
Generates metrics reports on monthly activities related to quality agreements.
Participates in the change control activities related to Allergan raw material change notifications from suppliers. Performs quality assessments to changes related to raw materials, updates impacted documentation and writes/reviews validation/qualification protocols and reports.
Contributes in generating and maintaining the approved supplier list repository.
Complies with all GxP and safety requirements, SOPs and company policies and procedures.
Required Knowledge and Skills
Experience in supplier quality management.
Experience in management of raw materials, testing, and qualification.
Experience in change management (change controls).
Experience in generating quality agreements.
Knowledge of compendia monographs.
Demonstrated knowledge of Quality Systems, Current Good Manufacturing Practices (cGMPs), ICH, EU, FDA and MHRA regulations and requirements.
Interpreting and applying Federal, state, and local policies, procedures, laws, and regulations.
Business scientific and personal computer hardware and software applications, including advanced knowledge of word processing.
Business English usage, spelling, grammar, and punctuation.
Good interpersonal and communications skills with internal and external customers orally and in writing.
Attention to detail.
Managing multiple projects, duties, and assignments.
Establishing and maintaining cooperative working relationships with others.
Minimum
Qualifications:
Education and Experience
Bachelor's degree from an accredited college or university in a scientific field
Minimum 5 years of Quality Assurance related experience in a regulated industry
LI-RM4
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives. Our success is powered by our world-class team's commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world's fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn't just welcomed, it's encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
Position Description
Under general supervision, oversees the completion and accuracy of any of the following; preparation, negotiation, and maintenance of quality agreements, management of centralized electronic repository for quality agreements, generation of metrics reports, management of supplier change notifications and change controls, and approved supplier list management.
Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
Preparation of new quality agreements with various Allergan suppliers.
Updates and maintains existing quality agreements.
Maintains global quality agreement repository. Filing of all quality agreements in the repository.
Contributes in the generation and maintenance of quality agreement templates and procedures.
Generates metrics reports on monthly activities related to quality agreements.
Participates in the change control activities related to Allergan raw material change notifications from suppliers. Performs quality assessments to changes related to raw materials, updates impacted documentation and writes/reviews validation/qualification protocols and reports.
Contributes in generating and maintaining the approved supplier list repository.
Complies with all GxP and safety requirements, SOPs and company policies and procedures.
Required Knowledge and Skills
Experience in supplier quality management.
Experience in management of raw materials, testing, and qualification.
Experience in change management (change controls).
Experience in generating quality agreements.
Knowledge of compendia monographs.
Demonstrated knowledge of Quality Systems, Current Good Manufacturing Practices (cGMPs), ICH, EU, FDA and MHRA regulations and requirements.
Interpreting and applying Federal, state, and local policies, procedures, laws, and regulations.
Business scientific and personal computer hardware and software applications, including advanced knowledge of word processing.
Business English usage, spelling, grammar, and punctuation.
Good interpersonal and communications skills with internal and external customers orally and in writing.
Attention to detail.
Managing multiple projects, duties, and assignments.
Establishing and maintaining cooperative working relationships with others.
Minimum
Qualifications:
Education and Experience
Bachelor's degree from an accredited college or university in a scientific field
Minimum 5 years of Quality Assurance related experience in a regulated industry
LI-RM4
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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