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 pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective 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 every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
This position performs as QA specialist in the area of quality assurance oversight of operations, production, process and equipment systems and computer validation at the Waco facility. Responsible for the issuance of all batch related documents for manufacturing, production, validation, and quality assurance departments at the Waco facility with compliance to site Standard Operating Procedures and current Good Manufacturing Practices.
Main Areas of Responsibilities
Quality Assurance oversight of operational activities, production, and validations and Technical Services projects, ensuring that QA systems and manufacturing/engineering systems have an independent assessment in order to remove any potential conflict of interest between ownership and administration.
Ensuring process and equipment validations meet current regulatory expectations (cGMP compliance) by providing guidance and executing both internal and external audits of our processes.
Serving as the QA representative on validation and technical services projects.
Reviewing and approving as Quality Assurance site process and equipment validation documentation representative, including protocols, deviations, and final reports.
Generating appropriate purchasing (CE's) and documentation for Quality Assurance validations projects and URS and FRS requirements.
Supporting change control activities associated with processes and equipment validations.
Managing and coordinating QA support for new and existing process equipment validation implementations.
Serving as the QA liaison with all vested parties including QA/QC laboratories, IS, Manufacturing, and Engineering relating to process and equipment validations.
Providing CSV oversight based on the education and training of the individual.
Maintain a clean and organized work area.
Assist Allergan in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.
Perform all assigned duties according to departmental SOP's and cGMP's.
Remain current on proper procedures by reviewing current, revised, and new SOP's relating to the job and to the department.
Complete and remain current with all required cGMP and safety training.
Perform other duties as assigned.
Performing the Quality Assurance Issuance of all batch related documents for manufacturing, production, validation, and quality assurance departments.
Issue batch records to support manufacturing and Production for the Waco facility ensuring accuracy, compliance, adherence to Data Integrity, and current Good Manufacturing Practices.
Issue PSO, Clinical Studies, Demonstration, and Validation Batch Records for Production use.
Assist Documentation Department to prepare, assign, and issue logbooks for the Waco facility.
Demonstrated ability to apply analytical methods
Broad understanding of Quality Engineering activities
Detail-oriented and self-motivated
Ability to read, comprehend, write, and communicate effectively in English.
Ability to carry out detailed written or oral instructions.
Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
Basic user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer based systems.
Physically able to lift up to 40 lbs. for men and 35 lbs. for women.
Education and Experience:
Minimum B.S. Engineering, statistics, or sciences degree from an accredited institution; Graduate degree is preferred.
Minimum of three (3) years of experience with a minimum of one (1) year working in relevant areas such as process validations or technology transfer.
A Master's degree may substitute for one year of experience.
Strong user of Excel and Statistical programs like Minitab
Prefer experience in a GMP regulated environment.
Prefer experience in an aseptic manufacturing environment