Associate Data Reviewer, QC

AbbVie; Worcester (MA); Vor Ort; USD 59.000 - 99.000; Vollzeit

Benefits dieser Stelle

Paid time off

Medical/dental/vision insurance

401(k)

Zusammenfassung

AbbVie is seeking an Associate Data Reviewer, QC to support the Quality Function within Operations. The role encompasses GMP data review, incoming quality assurance of drugs and packaging materials, and quality engineering responsibilities.

Responsibilities include on-the-floor and off-the-floor data review, data archiving, and ensuring conformance with AbbVie Quality Systems and regulatory requirements. Collaboration with Management on quality initiatives is expected.

Qualifikationen

• Bachelor’s degree or 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.

Aufgaben

• Performs Routine and STAT Review of Lab test data including On-the-Floor Review and Off-the-Floor Review for low complexity test methods.
• Completes 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.

Kenntnisse

Quality Systems knowledge

cGMP familiarity

Regulatory familiarity

Ausbildung

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

Tools

LIMS

EDMS

Jobbeschreibung

• Compensation: USD 58,656 - USD 99,000 - yearly

Company 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.

Job Description

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 Routineand STATReviewof Lab test data including On-the-Floor Review, and Off-the-Floor Review for low complexity test methods.
• Completereviewof 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.

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.

Additional Information

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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.