Product Review Coordinator IV

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 Summary

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 Standard Operation Procedures and current Good Manufacturing Practices.  This function will be capable to perform this records reviews on the shop 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.

 

Job Details

This position is responsible for the following:

• 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, 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. 
• Carry out and assist in the on-going training of new and existing personnel, as appropriate.
• Assess and understand events that may not be in accordance with procedures or cGMPs.  Make decisions consistent with job.
• Empowered to make Quality decisions.
• Be part of Operation area T-2 meetings.
• Participate and support OPEX initiatives and seek process innovation and continuous process improvement.
• 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

Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.

 

Regulated Responsibilities (including cGMP and EHS)

Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA

Qualifications
Education and Experience:

Minimum requirements for this position are:

 

Education

B.S. or B.A. in Business or Technical Field required.  However, a combination of education and relevant work experience may be considered for substitution for the degree requirement.

Experience: Technical

Three (3) years of experience in handling and reviewing documentation records.

Experience: Systems

One (1) year of both Microsoft Word and Microsoft Excel experience. SAP experience preferred.

Experience: Regulatory

Three (3) years of experience in a CGMP Environment

Experience: Aseptic

Prefer experience in an aseptic manufacturing environment

Significant Work Activities
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.