AbbVie QA Associate I/II, Data Reviewer (M-F, 2pm-10:30pm) in Worcester, Massachusetts
QA Associate I/II, Data Reviewer (M-F, 2pm-10:30pm)
USA, Massachusetts, Worcester
1 additional location
AbbVie Bioresearch Center (ABC) in Worcester, MA is seeking a QA Associate, Data Reviewer to join their team on 2nd Shift, Monday through Friday from 2:00pm-10:30pm.
Response for on-the floor review of Production Batch Records, Worksheets and Changeover Protocols utilized in cGMP manufacturing facility for accuracy and GMP compliance.
Interact with Production personnel to resolve discrepancies and deviations.
Responsible for various aspects of quality assurance and quality control related to their functional area.
Ensures that product within the plant is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements.
Support troubleshooting and resolution of quality compliance issues.
Communicates with Management for Quality Management Review, Quality Initiatives, etc.
Incumbent is responsible for quality decisions related to their functional area to ensure compliance with AbbVie Quality Systems and cGMPs.
Work closely with Manufacturing to ensure document changes, deviations and CAPAs are performed in compliance with SOP’s cGMP regulations.
Provide quality assurance support for internal projects as deemed necessary.
Review changes to documents (including, but not limited to, SOPs and batch records), following established cGMP guidelines.
Track and trend batch record review and related issues.
Contribute and adhere to safety, environmental, quality, and EEO/AA standards of the Corporation, Division and Location.
Provide QA support for a variety of projects at the site. These projects can include putting procedures in place for new manufacturing areas, revisions to procedures for updated areas, assisting in implementation of new systems within the quality and regulatory arena, etc.
Position will be hired based on level of experience.
BS in a scientific discipline, or equivalent experience
0- 4+ years’ experience in a cGMP-related field (Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry)preferred.
Strong communication skills, both oral and written
Strong computer skills utilizing a Microsoft environment (e.g. Word, Excel, PowerPoint)
Batch record review experience and/or material inspection experience.
This position is accountable for compliance to site, division and corporate procedures in his/her work area.
Accountable for meeting established department standards and goals.
Accountable for reviewing production batch records and addressing related issued.
Key AbbVie Competencies:
Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance.
Learns fast, grasps the “essence” and can change the course quickly where indicated.
Raises the bar and is never satisfied with the status quo.
Creates a learning environment, open to suggestions and experimentation for improvement.
Embraces the ideas of others, nurtures innovation and manages innovation to reality.
AbbVie is an Equal Employment Opportunity employer: 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.
Significant Work Activities and Conditions: N/A
Job Type: Experienced