AbbVie

Manager, Quality Control Laboratory

Employer
AbbVie
Location
Barceloneta, Puerto Rico
Posted
Apr 28, 2021
Ref
2009852
Required Education
Bachelors Degree
Position Type
Full time
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.

Purpose:

Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of site leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QA Site Director.     

Responsibilities:

•Manages the Quality Control (QC) laboratory including direct reports and budgetary responsibilities
•Member of the Laboratory Center of Excellence (COE)
•Serves as the standalone laboratory systems and site Maximo administrator
•Reviews and approves raw materials and commodities including ERP approval
•Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs
•Qualification and validation protocol writing, review, and approval
•Actively participates in Periodic Validation Reviews, Annual Product Reviews, internal audits, and process data reviews
•Provides front room and laboratory SME support during regulatory agency and internal inspections
•Manages change related to compendia, supplier/service provider notifications, material specifications, analytical test methods, test method validation, SOPs, batch records, and site service requests
•Leads the implementation of Quality-related projects including metrics


Qualifications

Qualifications:

•Bachelor’s degree in Chemistry with 10 years of pharmaceutical Quality experience (preferably in QC) 


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
M
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.