Product Review Coordinator III - A1 or B1 shift
Posted on: July 10, 2019
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
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
- 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.
- Three (3) year experience in handling and reviewing
- One (1) year of both Microsoft Word and Microsoft Excel
experience. SAP experience preferred.
- Three (3) years of experience working in a GMP regulated
- Working knowledge of Quality Assurance systems, cGMP?s, ISO
13485, CMDRs, and EMEA regulations.Preferred Skills/Qualifications
- Prefer experience in an aseptic manufacturing environment.
- Excellent analytical and problem solving skills.
- 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
- Ability to read, comprehend, write, and communicate effectively
- Ability to carry out detailed written or verbal
- 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
- High School Diploma or GED Equivalent.
- Associates degree preferred or Bachelor?s degree in the
Sciences or Technical field preferred.
Keywords: Allergan, Waco , Product Review Coordinator III - A1 or B1 shift, Other , Waco, Texas
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