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 will be responsible for reviewing finished product, semi-finished product, and compounding Batch Records for all products manufactured and/or packaged at the Waco facility. Responsible for performing the Quality Assurance review of product records to support the final disposition process.
Responsible for the issuance of all batch related documents for manufacturing, production, validation, and quality assurance departments.
Please note the available shifts:
A2 - 7:00PM - 7:00AM; Sunday, Monday, Tuesday, every other Saturday
B2 - 7:00PM - 7:00AM; Wednesday, Thursday, Friday, every other Saturday
Main Areas of Responsibilities
Reviews finished product, semi-finished product, and compounding Batch Records.
Collates, review, files, and submits for approval all product Batch Documentation Records.
Collaborates with Documentation Specialists to ensure compliance and conformity to procedures, specifications and Good Manufacturing Practices.
Reviews documents and collaborates with Production to identify defects and manufacturing trends.
Actively provides input and suggestions to help analyze and resolve Production problems.
Review batch records to support product release schedule for the Waco facility ensuring regulatory compliance, customer satisfaction and delivery of products.
Prepares required documentation regarding batch disposition to international sites as required.
Identifies and brings to resolution all batch record discrepancies to prevent a regulatory impact.
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.
Prefer experience in an aseptic manufacturing environment
Excellent analytical and problem solving skills, detail oriented.
Excellent organizational skills.
Ability to manage multiple tasks.
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.
Physically able to lift up to 40 lbs. for men and 35 lbs. for women.
Three (3) years of experience in handling and reviewing documentation records.
One (1) year of both Microsoft Word and Microsoft Excel experience. SAP experience preferred.
Three (3) years of experience in a CGMP Environment
Working knowledge of Quality Assurance systems, cGMP's , ISO 13485, CMDRs, and EMEA regulations.
High School Diploma or GED Equivalent.
Associates degree preferred or Bachelor's degree in the Sciences or Technical field preferred.