Sr. Specialist, Quality Validation

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

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

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Qualifications

Qualifications:

•Bachelor's 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

 [MB1]I 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 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. ​

• 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 Company's soleand 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 opport