QC Product Release Coordinator II

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
QC Product Release Coordinator II

Due to COVID, phone interviews will be conducted if Skype video is not an option. Please include your candidate's phone # and email address (if Skype video) when you confirm the interview.

Summary: This position is responsible for, but not limited to, reviewing processing batch records for compliant completion of manufacturing batch records to determine all necessary requirements were met for final disposition of LifeCell products for final release. This position is required to support overall departmental needs such as data trending, audit SME support, documentation updates among other tasks.

Key Duties and Responsibilities:
o Review processing batch records for compliance with all specified requirements and procedures.
o Make final determination regarding suitability of LifeCell products for final release of a lot to Finished Goods and/or other dispositions, including rejections.
o Work closely with Manufacturing and Quality to resolve any discrepancies uncovered during batch records review.
o Generate Certificate of Conformances as deemed necessary.
o Initiate reworks when applicable for nonconforming product to ensure they are conforming
• Quarantine product as deemed necessary for identified non-conforming product.
• Complete transactions as deemed necessary for acceptable or non-conforming product.
• Compile and perform trending of issues encountered at batch record review to identify any drift in performance or potential issues.
• Confirm research consent for lots designated for marketing, research or validation purposes
• Investigate Nonconformance and CAPA's.
• Assist Supervisor with various projects and metrics as deemed necessary.
• Initiate change controls for the department. (ECO's)

Qualifications

Job Qualification (Minimum Requirements):
• Ability to work in a team environment
• Must be able to manually maneuver carts and material handling equipment weighing up to 10 lbs. while wearing appropriate personal protective equipment

Education and Experience
• High School/Secondary School/ Equivalent
• Associate's or bachelor's degree preferred

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
• 3-5 years of experience in GMP environment.
• Familiar with AATB, ISO, FDA and other regulations and guidelines.
• Knowledge of Microsoft Excel, Microsoft Word, TrackWise and SAP.

• Experience in Quality, Science, Biologics or related field.
• LSS trained (preferred)

Minimum Qualifications:
• Ability to work in a team environment
• Must be able to manually maneuver carts and material handling equipment weighing up to 10 lbs. while wearing appropriate personal protective equipment

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.