AbbVie

Manager, Quality Control

Employer
AbbVie
Location
Branchburg, NJ, United States
Posted
Jan 21, 2021
Ref
206328
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
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 .

Description - External

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

What Your New Manager Wants You To Know

This position is responsible for, but not limited to, managing and leading the Quality Control Material and Tissue Inspection teams. This position shall oversee the appropriate allocation of personnel and resources to ensure timely inspection and disposition of material and tissue. Additionally, will lead process improvements and other requirements for both areas ensuring a timely, compliant and efficient process. Supports and partners with cross-functional teams to resolve issues with raw materials, components, and tissue as needed. Assists in documentation updates and related change controls activities. Ensures business continuity by releasing conforming raw materials, components and tissue in accordance with applicable standards, procedures component specifications. Ensures appropriate segregation and identification of raw materials, components, or tissue found to be nonconforming. Reviews inspection records to verify accuracy and completeness of information. Perform applicable actions for Nonconformance Reports (NCRs), Supplier Issues (SIs), Engineering Change Orders (ECOs), etc.

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
  • Manage all QC Incoming and Tissue Inspection activities and teams.
  • Review Change Controls (CC) to assess impact to process and documentation.
  • Act as a key liaison between the material and tissue inspection teams with other cross functional and support groups.
  • Directly manage the activities of the team inspecting incoming raw materials, tissue and components to assure that said items conform to component specifications and/or LifeCell Operating Procedures (LOPs).
  • Communicate with management and escalates as needed, led by example, builds strong and collaborative relationships with internal/external customers.
  • Responsible for training, safety and people's development and performance.
  • Responsible for ensuring adequate resources/staff to maintain business continuity, assigning work, meeting deadlines, interpreting, and ensuring compliance to organizational policies
  • Initiate and/or investigates Non Conformances when applicable if determined the product does not comply with written LifeCell procedures/specifications.
  • Review inspection records to verify accuracy and completeness of information prior to release of the item or tissue to Production, the Stockroom, QC Lab, or other department.
  • Ensure inspection records are completed in accordance with current good documentation practices.
  • Ensure nonconforming materials and tissue are segregated and quarantined in Quality Control area and ensures materials and tissue are properly labeled to reflect status in accordance with LOPs. Ensures item or product disposition is conducted in accordance with NCR, SI or applicable quality record.
  • Performs inspections, SAP transactions, transfer, status changes, and inventory transactions as needed.
  • Develop training materials for QC material and tissue inspection areas as needed.
  • Act as a mentor and coach to team members, ensuring development plans are in place.
  • Active member in other cross-functional collaborative efforts and attends huddles, team meetings, and project meetings.
  • Maintains 5S and ensures inspection areas remain as a safe and pleasant working environment

Qualifications

You Bring
  • Bachelors degree required
  • 3 - 5 years of experience in a GMP environment performing Quality Inspection related duties as listed in Key Duties & Responsibilities.
  • 3 - 5 years of prior supervisory experience required
  • Demonstrated strong leadership skills
  • Ability to carry and lift boxes weighing up to 50 lbs.
  • Ability to work varied schedule with some potential weekend, early morning or late evening hours, if needed.
  • AATB certification preferred.
  • Advanced computer skills - high knowledge and understanding of Windows based computer systems such as Microsoft Office Suite.
  • Experience with Current Good Manufacturing Practices (cGMPs) and working in a regulated industry; familiarity with AATB, ISO, FDA, and/or USP regulations guidelines.
  • Experience with ANSI or other sampling guidelines
  • Experience with Enterprise Resource Planning (ERP) software, such as Oracle or SAP.
  • Demonstrated knowledge of Quality Control inspection techniques. Basic knowledge of statistical techniques and quality tools
  • Strong organizational abilities and problem-solving skills
  • Detail-oriented and self-motivated
  • Ability to carry out detailed written or oral instructions
  • Ability to work and communicate efficiently with others in a professional and effective manner to build strong, lasting customer relationships and developing a strong team by support and leadership of group work area
  • Ability to handle a wide variety of tasks under critical time constraints

In this role, we're looking for a leader who will :
  • Act as an Owner
  • Be Excellence Focused
  • Act as an Influencer

Significant Work Activities
Continuous sitting 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.