AbbVie

Change Management Specialist-Product Labeling

Employer
AbbVie
Location
Irvine, California
Posted
Jul 07, 2021
Ref
2111135
Required Education
Associate 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.

The Change Management Specialist is responsible for labeling project execution within a highly cross functional environment. Change Management Specialist generates ECRs (engineering change requests) in SAP and change documents along with coordinating approvals that are associated with printed packaging, implementation, and packaging instructions for internal manufacturing sites for the creation of Bill of Materials and change documentation for third party sites. Change Management Specialist ensures accuracy of data entry and management of the information entered in SAP for use in ECRs. The position has responsibility for key tasks within labeling projects specific to change management, packaging coordination, and communicating changes to the sites. This position must collaborate closely with Packaging Artwork Associates, Regulatory, Site, Quality and any department whose input and approval are necessary to ensure product launch, change requests, regulatory and manufacturing dates are met.

 

Responsibilities:

 

  • Ensures development, review/approval, issuance and distribution of accurate, quality ECR/change records into a document-controlled system following the ECR/change management process.
  • Ensures data entries in SAP ECRs and other change records are created or revised as required for US products.
  • Ensures ECRs and change documents are created expeditiously to accommodate aggressive launch and manufacturing requirements and within the product approved specifications by all functional departments responsible for approval.
  • Ensures accuracy and completeness of the change request to Quality and Regulatory GMP standards and managed within the Artwork Management System.
  • Interfaces with various organizations to identify requirements and obtain documentation to support labeling and packaging projects.
  • Complete product obsolescence tasks in various change management systems
  • Collaborates with the sites and regional ECR teams to complete the activities necessary to add packaging sites into the artwork management system and SAP necessary for labeling change management.
  • Collaborates with cross-functional team members to efficiently orchestrate all activities and meet  product labeling requirements from the site and all stakeholders. Ensures agreed upon timelines are met.
  • Complete Change Control tasks in change management system
  • Act as owner for specific labeling business processes and assume role of change documentation subject matter expert.
  • Key liaison and subject matter expert for packaging and labeling at internal sites and third party manufacturers.
  • Understand performance within area of responsibility and identify opportunities for continuous improvement.

Qualifications

Qualifications:

  • Minimum Bachelor's Degree in Business, Engineering or Supply Chain or 3 years equivalent experience in a pharmaceutical or biotech manufacturing company.
  • Preferred Bachelor's Degree in Business, Engineering or Supply Chain or 4 years experience in Operations, Regulatory or a Quality environment with a comprehensive understanding of the drug and packaging process normally acquired through education or manufacturing and operations experience in a GMP environment.
  • Understanding of change control management related to pharmaceutical or cGMP environment.
  • Understanding of packaging operations.
  • Proven experience with SAP.
  • Above average computer literacy in various software applications, such as Word and Excel, and change management system.
  • Excellent communication and interpersonal skills. Proficiency in English (both written and oral)
  • Logical problem-solving skills.
  • Excellent organizational skills. Must be detail-oriented and quality minded.
  • Understands Regulatory, Quality and Supply Chain aspects of product labeling.
  • Experience working effectively across multiple functional areas and in complex matrix environments.

 

 


Significant Work Activities
N/A
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.