Associate Data Reviewer, QC

AbbVie Inc.; Worcester (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

AbbVie is seeking an Associate Data Reviewer in QC to support the Quality Function within Operations. The role involves GMP data review, QA/QC activities, and ensuring products are manufactured to AbbVie Quality System and regulatory requirements.

The position requires a Bachelor’s degree or 2+ years in pharma/biologics, experience with electronic document management and LIMS, and strong communication skills. Shift: Sun-Wed, 6am-4pm.

Qualifications

• Bachelor’s degree, or at least 2 years of combined experience in manufacturing, QA, QC, or R&D within the pharmaceutical or biologics industry.
• Working knowledge of electronic document management and laboratory information management systems.
• Familiarity with Quality Systems, cGMP, and other applicable regulatory requirements.
• Strong verbal and written communication skills.

Responsibilities

• Performs Routine and STAT Review of Lab test data including On-the-Floor Review, and Off-the-Floor Review for low complexity test methods.
• Complete review of assays, data mining projects, and archiving of data
• 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.

Skills

Strong verbal and written comms

Education

Bachelor’s degree or 2+ years pharma/biologics experience

Tools

EDMS

LIMS

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

The Associate Data Reviewer, QC supports the Quality Function that they are responsible for within Operations. This could include: GMP Data review, Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance. Expectations that the Quality Associate will maintain high quality levels on all aspects of their job while achieving high levels of efficiency.

Responsibilities

• Performs Routine and STAT Review of Lab test data including On-the-Floor Review, and Off-the-Floor Review for low complexity test methods.
• Complete review of assays, data mining projects, and archiving of data
• 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.

Requirements

• Bachelor’s degree, or at least 2 years of combined experience in manufacturing, QA, QC, or R&D within the pharmaceutical or biologics industry.
• Working knowledge of electronic document management and laboratory information management systems.
• Familiarity with Quality Systems, cGMP, and other applicable regulatory requirements.
• Strong verbal and written communication skills.

Shift: Sunday- Wednesday, 6am-4pm

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html