Associate Data Reviewer, QC

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.

Qualifications :

• Bachelors 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 

Additional Information :

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time