Job Description

About AbbVie
AbbVies mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Sr. Quality Assurance Analyst

This position performs as QA analyst in the area of quality assurance oversight of operations, production, process and equipment systems and validations at the Bioscience Laboratories Irvine facility.

Main Areas of Responsibilities

* Quality Assurance oversight of operational activities, production, and validations and Technical Services projects, ensuring that QA systems and manufacturing/engineering systems have an independent assessment to remove any potential conflict of interest between ownership and administration.
* Serving as the QA representative on validation and technical services projects.
* Reviewing and approving as Quality Assurance site process and equipment validation documentation representative, including protocols, deviations, and final reports.
* Supporting change control activities associated with processes and equipment validations.
* Managing the review/approval of DS development master batch records, executed batch records, manufacturing data, and validation and technical reports.
* Assist Allergan in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.
* Perform all assigned duties according to departmental SOP's and cGMP's.
* Remain current on proper procedures by reviewing current, revised, and new SOP's relating to the job and to the department.
* Complete and remain current with all required cGMP and safety training.
* Perform other duties as assigned.

Incumbent has full authority to make decisions and/or take actions required to carry out job duties. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements, and objectives. The incumbent must be willing to take temporary assignments as required.

Qualifications
You Bring

* BS degree in Biology, Chemistry, Biochemistry, or a closely related discipline (or equivalent years of experience).
* CQA is preferred.
* Minimum of five 3-5 years of QA experience within a pharmaceutical environment.
* Must have experience in change control, non- conformance, CAPAs
* QC analytical experience is preferred.
* Strong user of word processing programs
* Prefer experience in a GMP regulated environment.
* The ability to comprehend processes in short time frames, coupled with the need to effectively communicate verbally and in writing.
* Development of problem-solving approaches that can be applied to multiple functions within the DSO organization.
* Ability to interpret multiple standards and apply to department activities.
* Process and results oriented with the ability to lead cross functional teams and solve key problems.
* Strong analytical skills including proficiency in the use of computer applications and office automation.
* Desire to take on increased levels of responsibility.
* Ability to travel about 5%

Significant Work Activities
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.