*Product Review Coordinator IV - UD Fill - B1 shift

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

Position Overview

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 ensuring compliance with AbbVie Standard Operation Procedures and current Good Manufacturing Practices.
This function will be capable to perform records reviews on the production floor including those designed as controlled classified areas. This position is responsible for performing the Quality Assurance review of product records to support the final disposition process in Waco and coordinating training within the department. 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

• Real time Review and approval of records by QA on the shop floor. These records include but not limited to finished product, semi-finished product, and compounding Batch Records.
• Understand cGMPs and procedural requirements for your area of responsibility and be a resource to operators and other personnel to ensure compliance to these requirements.
• Make decisions consistent with job responsibilities, regulations and Allergan procedures and policies. Provide appropriate comments to cGMPs documents, when needed. Provide timely feedback and details to supervision and other impacted personnel.
• Work together with Operations on resolving quality events on time.
• Provide approval for re-work and in-process retest forms as well as any other supporting document that requires Quality signature.
• Be gown certified to provide support to controlled classified areas.
• As part of the batch review process perform continuous Gemba walks in the operation area.
• Complete and conform to all training requirements for job role, including company-required and job role-specific training.
• Reviews documents and collaborates with Production to identify defects and manufacturing trends.
• Actively provides input and suggestions to help analyze and resolve Production problems.
• 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.
• 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.
• Perform other duties as assigned.

Qualifications

Requirements

• Three (3) year 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 working in a cGMP regulated environment.
• Experience in an aseptic manufacturing environment preferred.

Preferred Skills/Qualifications

• Excellent analytical and problem-solving skills, detail oriented.
• Excellent organizational skills. Ability to manage multiple tasks.
• Working knowledge of Quality Assurance systems, cGMP's, ISO 13485, CMDRs, and EMEA regulations.
• 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 verbal 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.
• Be able to be gown certified to provide support to controlled classified areas.

Education

• Bachelors degree in the Sciences required; a combination of education and relevant pharmaceutical and/or regulatory experience may be considered for substitution for the degree requirement.

Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.