Specialist, Quality Validation

North Chicago, IL - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Purpose:

The primary responsibility for the Quality Validation Specialist is the Quality oversight and overall approval of validation and engineering change management activities. The Validation engineering department will support the implementation of the Validation quality program and will be expected to independently manage 5 key projects simultaneously.

Responsibilities:

Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements

Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility

Executes tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment utilities facilities automated process controllers information systems cleaning processes manufacturing processes laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended

Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy

Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation

May supervise contract validation resources in the timely completion of activities in his/her area of responsibility

May lead author or review investigations and implementation of preventive and corrective action

Qualifications :

Qualifications:

Bachelors Degree Required (preferably in Biology Chemistry or Engineering)

6 years of overall experience in Manufacturing Quality or Engineering including 4 major validation subjects (e.g. Computer Equipment Cleaning Process etc.) preferred

Strong verbal and written communication skills

Solid problem solving and analytical skills

Solid interpersonal skills including ability to negotiate/influence without authority

Ability to manage complex projects and multiple projects (5) simultaneously

Knowledge of quality / compliance management as well as regulations and standards affecting API Bulk Drug or Finished goods manufacturing preferred

MB1I know you had mentioned not changing the qualifications section but we could probably remove this bullet. It appears to be a relic of a previous time when this role was expected to do some supervisory work

Key Stakeholders

Various stakeholders within the site including but not limited to Plant Operations Quality Engineering/Maintenance and Science & Technology

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 ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand 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.
This job is eligible to participate in our long-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 anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand 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 :

Employment Type :

Full-time

Purpose:The primary responsibility for the Quality Validation Specialist is the Quality oversight and overall approval of validation and engineering change management activities. The Validation engineering department will support the implementation of the Validation quality program and will be expe...