Allergan Manufacturing Operator III, Unit Dose Filling, B1 Shift in Waco, Texas
Manufacturing Operator III, Unit Dose Filling, B1 Shift
Waco, Texas, United States at https://agn.referrals.selectminds.com/jobs/5686/other-jobs-matching/location-only
Jun 13, 2018Post Date
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.
Under general direction, the Product Surveillance Representative will field incoming phone calls from patients, health care professionals, and internal personnel reporting adverse events or calling with questions regarding complaint investigations and product claims. The Product Surveillance Representative will provide information, initiate complaint files, and process claims for financial reimbursement and replacement products in accordance with Allergan’s internal policies and applicable regulatory requirements.
“The employee must conduct their work activities in compliance with all Allergan internal requirements and with all applicable regulatory requirements, including knowledge of operating in a controlled environment per the requirements of 21 CFR 820, ISO 13485 and ISO 14971. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives. ”
- Initiate and conduct initial investigation for complaint files, following complaint handling regulation 21 CFR 820.198 and internal procedures. Analyze information reported in order to conduct immediate follow up with complainant to obtain required information.
Initiate and set up complaint files. Maintain and update database. Record all complaint activity in both hard copy (when applicable) and computer files.
Assess incoming information across all product lines for complaint data. Coordinate with inter- and intra-departmental customers to ensure complaints and inquiries across all product lines are handled appropriately.
Receive information and respond to questions for on-going complaint investigations and update applicable records.
Maintain a knowledge and understanding of current MDR regulations, MDR guidelines, MDR interpretations, product labeling, other federal laws governing medical devices, Department of Transportation (DOT) requirements for explant returns, and the FDA mandated Retrieval Program.
- Initiate and process product reimbursement and claim records.
Inform internal and external customers of Allergan’s reimbursement policy and product return requirements.
Contact internal and external customers if claim is incomplete. Ability to monitor several cases at once, including status and follow-up as necessary.
Respond to verbal and written requests from internal and external customers for payment of warranty in a timely manner.
Ability to identify potentially litigious customers, and forward to management for resolution.
- Provide generalized company, departmental and product knowledge as required.
Communicate with the Quality Assurance, Clinical Studies, Customer Care, Operations, Marketing departments, and Allergan manufacturing facilities.
Handle sensitive conversations with patients and/or physicians, avoiding litigious or compromising issues, providing information, education and assurance to the patient and/or physician regarding product and service, effectively utilizing “talking points” and communicating corporate policy.
- Support the department on special projects as needed.
Previous experience working in a manufacturing setting preferred. Previous experience with high speed production lines and equipment preferred.
Experience working in a GMP regulated environment preferred.
Experience working in an Aseptic Production environment preferred.
Detail-oriented and self-motivated
Excellent hand-eye coordination and manual dexterity.
Excellent math skills; ability to add, subtract, multiply, and divide.
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.
Ability to work any shift (up to 12-hours) as required dependent on business needs.
Physically able to continuously stand and walk.
Physically able to lift up to 40 lbs. for men and 35 lbs. for women.
Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently.
Effective and efficient operation of manual and automated production equipment.
Ability to use, clean, and store tools and other devices required for the performance of the job in a manner which prevents damage to the tools and / or equipment.
- High School degree or equivalent.
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.