Senior Analyst, Quality Engineering (On-site)
Senior Analyst, Quality Engineering (On-site)
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Salary Not Disclosed
1 Vacancy
Job Description
Purpose
Primarily responsible for quality assignments related to batch records quality approvals exception
reports metrics and other documentation.
Responsibilities:
- Review/approve/release batch record packets and associated documentation
- Provide quality approvals of materials in the materials management system as defined by procedures
- Write/review/approve exception documents and corrective actions/preventive actions (CAPA) and ensure they meet timeliness requirements
- Review/approve clinical documentation and specifications as applicable
- Write/review/approve policies/processes/procedures and related documents
- Lead/assist in the preparation and management of audits conducted by regulatory agencies customers R&D GxP Compliance
- Actively lead/participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality issues
- Generate analyze and report quality metrics to management
- Lead/participate with support groups in developing/prioritizing QA activity timelines
- Actively monitor the effectiveness of processes and quality of project work with management and propose and execute quality/process improvements
This role will be onsite 5 days a week at our North Chicago location.
Qualifications :
- Bachelors degree or equivalent experience is required preferably in life sciences or engineering
- 6 years experience in Quality Assurance or related field preferred healthcare industry or experience in quality function
- Strong understanding of US and international regulations for quality systems and compliance
- Experience in coordination and planning of complex activities
- Proven organizational skills
- Interpersonal team leadership and negotiation skills to handle conflicting priorities
- Effective use of oral and written communication skills to clearly communicate the quality position and the actions necessary to resolve issues
- Ability to identify and resolve complex problems through effective use of technical and interpersonal skills
- Capable of clearly presenting and justifying quality requirements throughout all levels of management
- Accreditation by a professional body is highly desirable. Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).
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 shortterm 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:
No
Employment Type :
Fulltime
Employment Type
Full-time
