AbbVie

*Mgr, Quality Laboratories

Employer
AbbVie
Location
Branchburg, NJ, United States
Posted
Oct 07, 2020
Ref
199953
Required Education
Doctorate/PHD/MD
Position Type
Full time
About AbbVie
AbbVie's 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 people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's 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 .

Job Description

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

Mgr, Quality Laboratories

What Your New Manager Wants You To Know

I am looking for an experienced Manager, QC Labs will act as subject matter expert (SME) on microbiology, sterilization, and production clean room controls including aseptic processing and environmental monitoring.

Sincerely,

Sr. Mgr, Quality Laboratories

YOU ARE more than just a title, YOU ARE...

A strategic thinker : Align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.

First class team player : Collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will

  • M anagement of Quality Control Laboratory personnel and activities, including QC Testing, Finished Product Testing, Microbiology Testing and the LIR/NCR/CAPA/Change Control processes as they relate to the laboratory.
  • Responsible for bringing innovative solutions to complex problems, especially in the areas of improved efficiencies and automation.
  • Ensure there is adequate, trained staff to accomplish Quality objectives, and ensure the collection, organization, analysing and reporting on data regarding nonconformances (OOS), and other quality issues, as determined by the Sr. Mgr. Quality Control.
  • Establish in-house capability of microbiological testing and microbial identification. Provide hands on guidance and training to junior level associates on laboratory testing and assure overall compliance to cGMPs and GDP.
  • Design and lead sterilization and microbiological needs of project teams based on regulation and guidelines, which includes autoclave loading pattern, terminal (ebeam) sterilization of product, in-process bioburden reduction and testing.
  • Assist with the development and implementation of policies and procedures as they pertain to all QC and Microbiology laboratories supporting the overall Quality program.


Qualifications

You Bring
  • 5-10 yrs. with Ph.D.
  • >10 yrs. with a Bachelor or Master's Degree
  • Extensive knowledge/experience of sterilization process, aseptic processing and clean room regulations, industry practices, quarterly dose audit and related ISO standards.
  • Experience with Microsoft Office Applications including Word, Excel, PowerPoint, and Outlook. Experience and knowledge in Data Integrity and governing regulations.
  • Ability to serve as a senior technical advisor. Ability to communicate at all levels and deliver highly technical information in clear and easy-to-understand terms.
  • Demonstrated organizational development skills. Able to identify, challenge and mentor department associates providing feedback, guidance and direction supporting individual development.
  • Organize and prioritize tasks and effectively communicate priorities to direct reports, peers and management.
  • In-depth knowledge in FDA, ISO, AATB, and USP regulations/guidelines.
  • Demonstrated experience working with internal and external customers. i.e. vendors, collaborating investigators, contract test labs. Comprehensive understanding of microbiology, aseptic processing and sterilization.
  • Willingness to work with potentially bio-hazardous materials including human and animal tissues and a variety of media.
  • Reviews sterilization microbiological practices against current industry regulations.
  • Experience developing sterilization methods; steam sterilization, radiation, aseptic processing.
  • Experience with regulatory guidelines for sterilization, microbiological, analytical and histological practices relating to clean room manufacturing, aseptic processing, and sterilization of human tissue, medical devices or pharmaceuticals.
  • Demonstrated mathematical, statistical, communication, technical writing, presentation, critical thinking and problem-solving skills.


We Will Give You 'The Allergan Edge'

At Allergan, we define an 'edge' as something that sets us apart, gives us an advantage and strengthens us to be better - for our customers, patients, investors and each other. Our 'edge' is our colleagues, and we are committed to making Allergan the best place for them to work and achieve career goals.

How do we do this? We Engage, Develop, and Reward our colleagues.

Engage. From Day 1, you are a bold leader who wants to make an impact. We listen to your ideas and questions, so we can be even better at what we do.

Develop. Learn every day, build new skills every day. We prioritize development, so our leaders are always ready for the next challenge and opportunity.

Reward. Exceptional performance creates exceptional opportunities and rewards. Financial awards and incentives are just a part of this - we invest in our people; celebrate success through recognition programs; and promote healthy lifestyles and work-life balance.

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.