QA Compliance Auditor
- Employer
- AbbVie
- Location
- Worcester, MA, US
- Start date
- Dec 5, 2018
View more
- Discipline
- Administration, Accounting, Regulatory, Legal/Compliance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown, Best Places to Work
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Job Details
AbbVie Bioresearch Center in Worcester, MA is seeking a QA Compliance Auditor to join their team. This QA Compliance Auditor will be responsible for implementing and maintaining a functional internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards.
Key Responsibilities:
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Key Responsibilities:
- Responsible for Regulatory Compliance at the plant level which includes planning and conducting internal compliance audits of all operations within the facility.
- Serve as plant administrator for all company and regulatory agency (i.e. DEA, FDA) inspections.
- Convey all violations to appropriate plant management/supervisory personnel via written reports and/or open discussions in audit wrap-up meetings.
- Follow up on audits to assure that action plans are developed and completed in a timely fashion.
- Keep current with all regulatory requirements and disseminate and interpret all regulatory requirements to plant personnel in a timely and accurate fashion.
- Consult with plant personnel on regulatory requirements and compliance related topics.
- Responsible for management review and associated metrics for the plant
- Administrate/coordinate the plant manufacturing materials and pest control programs.
- Coordinate and facilitate major plant quality improvement projects at the plant or company level.
- Perform process of metrics collection and analysis for compliance-related corrective and preventive actions (CAPA's).
- Bachelor's Degree, preferably in Science or Engineering, or equivalent related work experience is required.
- 3+ years of Biopharmaceutical experience
- Quality Assurance/Regulatory Affairs/Compliance experience required
- Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, MCA, DEA).
- Able to demonstrate extensive knowledge of plant and company level procedures.
- Ability to evaluate quality, production and support areas for compliance to GMPs. BOPs, etc.
- Strong decision making
- Ability to anticipate problems, identify and investigate them, and make recommendations to help resolve
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Company
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, and YouTube.
Stock Symbol: ABBV
Stock Exchange: NYSE
Company info
- Website
- http://www.abbvie.com/
- Phone
- 1-800-255-5162
- Location
-
1 North Waukegan Road
North Chicago
Illinois
60064
US
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