AbbVie Senior Trending Analyst in Lake County, Illinois

Description:
Individual will work in AbbVie’s global quality organization. Primary responsibilities include Product Quality Complaint (PQC) Trending for pharmaceutical, medical device and combination products. Role will interface with Product Quality Assurance (PQA) as well as OPs QENG to perform trending activities for all AbbVie products. Additional expectations include performing reconciliation of adverse events (AEs) and PQCs between AEGIS and SolTRAQs systems. Communication with internal and external AbbVie customers including international QA and PV affiliates regarding AEs and PQCs. Responsible for product complaint documentation, investigations, identification of potential adverse events and potentially reportable events. Responsibilities may include creation and submission of regulatory reports, coordination of customer communications and interfacing with third party vendors.

Responsibilities:

  • Perform PQC trending for all AbbVie products. This includes, but not limited to, pulling reports from SolTRAQs complaint system, evaluating data in Microsoft Excel including generation of graphs and pivot tables to compile data. Technical writing and good documentation practices are essential.
  • Evaluate trends against manufacturing process and release requirements for the product in question to determine if further investigation/CAPA is needed. Good analytical skills are needed.
  • Secondary responsibilities for this role include reconciliation of AEs in AEGIS system with PQCs in SolTRAQs system. This includes linking the records, ensuring all pertinent details are documented in the appropriate system. Additionally, reviewing for potentially reportable events and confirming documentation in records meet global regulatory requirements.
  • Ability to create formal documentation that meets GMP standards and can be used for regulatory filings and/or reporting. Examples include: Form 3500A and Med Dev.
  • Interface with Third Party Manufacturers, health care professionals, general public, internal customers, AbbVie functional areas and regulatory agencies.
  • Potential oversight of management of a project team or participation on a project team involving process improvements, new product launches, issue resolutions, etc.
  • Potential Responsibility of a specific section of the complaint process and employees activities involved with that processing step. Responsibility for global medical device evaluation and report creation.

Qualifications:

Basic:

  • Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
  • Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
  • Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
  • Solid written/verbal communication and organizational skills.
  • Advanced Microsoft Excel and data evaluation skills are required for this position.
  • Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
  • Bachelor’s Degree required; preferably in nursing, pharmacy, medical technology, engineering or scientific background (MLT, LPN, RN).
  • 5 years of work experience in a cGMP related industry or in a clinical setting (preferred)

Job Classification: Experienced
Job: QUALITY ASSURANCE
Primary Location: USA-Illinois-Lake County
Organization: Operations
Schedule: Full-time
Shift: Day
Travel: No
Req ID: 1706352

Equal Opportunity Employer Minorities/Women/Veterans/Disabled