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

Describe the primary goals, objectives or functions or outputs of this position.

The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant.
Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

Monitors Risk Management Program for the site to ensure it is in compliance with AbbVie policies and procedures in addition to all federal/state/global/local and pharmaceutical regulations.
Facilitates Risk Management activities (e.g., FMEA or any other Risk Management activities as specified in local and/or global procedures). Participates in Global and Local Risk Management documentation changes and change control activities.
Responsible for implementing and maintaining the effectiveness of the Quality System.
Support the ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.
Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
Approves standard operating procedures; ensures procedures comply with policy and make sense.
Approves calibration requests and ensures that these requests have appropriate product/process limits assigned.
Auditing of commissioning and validation documentation.
Develops product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses and FMEA’s. Develops and implements statistical quality programs and process monitoring systems.
For specific U.S. manufacturing sites, performs batch release.
Provide Risk Management training as required.

Qualifications

List required and preferred qualifications (up to 10). Include education, skills and experience.

Bachelor's degree, preferably in Biology, Chemistry or Engineering
6+ years of overall experience in Manufacturing, Quality or Engineering
Good verbal and written communication skills.
Good problem solving and analytical skills
Good interpersonal relations / communications skills
Good negotiation skills
Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

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 Company's sole and 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 opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Sr. Quality Engineer - Quality Risk Management