Associate Specialist, Scientific Compliance

AbbVie•North Chicago, IL

7d•$58,656 - $110,500•Onsite

About The Position

Ensure GxP compliance to AbbVie policies/processes/procedures, global regulatory requirements, and industry guidelines. Remain current with major compliance trends and their application within the biopharmaceutical industry. Serve as a business compliance liaison for Development Sciences (Dev Sci) scientific personnel involved in pipeline research and product development. Collaborate with cross-functional teams, including personnel from Dev Sci, other R&D groups, including QA, and AbbVie Operations, to ensure compliance with relevant policies, regulations, and industry standards throughout all research and development activities.

Requirements

Minimum of Associate's degree (scientific field preferred).
Typically 3 (Associate's), or 0-2 (Bachelor's) years of industry related (i.e. GxP) experience.
Good interpersonal skills with ability to effectively communicate in a clear manner; proficient in business/technical communications.
Good organizational and time management skills.
Strong attention to detail.
Works well in a fast-paced global team environment

Nice To Haves

Experience with document management processing is preferred.
Familiarity with various software applications such as Microsoft platform (i.e., SharePoint, OneNote, Word, Excel, etc.), Veeva Vault, Salesforce (AbbVie OneTrack), etc. is preferred
Basic understanding of R&D drug development/medical device processes preferred.

Responsibilities

Ensure compliance with Quality System (QS) documents, including the creation, modification, and management of QS documents.
Collaborate as part of a global document management team, engaging with cross-functional stakeholders at all organizational levels to facilitate document management and compliance objectives.
Act as a centralized point of contact to support the Quality Intelligence process on behalf of Development Sciences.
Learn new skills and contribute where needed within the Scientific Compliance team to support an “All for One AbbVie” approach.
Adhere to codes of conduct and ethical principles and ensure compliance with applicable AbbVie policies and procedures.
Utilize systems, documents, and tools to provide compliance support for centralized business function processes
Support compliance and process improvement initiatives to enhance efficiency and compliance.
Respond to unexpected occurrences and business needs.
Identify and appropriately escalate potential compliance risks.
Work in a highly team-based, cross-functional environment for daily activities/decision-making.
With oversight, manage several tasks simultaneously.