Specialist, QA Compliance

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.

Purpose
Responsible for assisting with the internal audit program that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards. 

Responsibilities

• Assists with planning and conducting internal compliance audits of all operations within the facility. 


• Provides support with company and regulatory agency (i.e. FDA, MHRA) inspections.


• Follow up on audits to assure that action plans are developed and completed in a timely fashion.


• Assist with management review and associated metrics for the plant.


• Provides support in the metrics collection and analysis for compliance-related corrective and preventive actions (CAPA’s).


• Work closely with the Compliance Manager in the handling of internal and customer audits and on the resolution of compliance issues. 


• Monitors and maintains plant compliance with Operations and regulatory/applicable standards/requirements.


• Assists in planning and performing Internal quality audits of all plant operations, including quality risk management,
  management responsibilities, process performance and product quality, documentation, change management and
  corrective & preventative actions.


• Schedule meetings with senior plant management to discuss audit observations. Track and follow up on all audit commitments.


• Reviews the acceptability of Corrective and Preventive Actions (CAPA) resulting from audit observations. Reconciles CAPA inadequacies with audited area.


• Participate in Operations Compliance, regulatory, third party and customer audits as facilitator or back room manager.



 
•  

Qualifications 

• Bachelor’s Degree, preferably in Science or Engineering, or equivalent related work experience is required.


• 3+ years of Biopharmaceutical experience. Quality Assurance/Regulatory Affairs/Compliance is preferred.


• Knowledge of cGMP, quality systems, regulations and standards for pharmaceuticals (e.g. CFR, Eudralex, PIC/S)


• Must have some knowledge of plant and company level procedures.


• Ability to evaluate quality, production and support areas for compliance to GMPs, BOPs, etc.


• Ability to identify and investigate problems and help to resolve them.



 
•  

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 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.