Senior Scientist I, Analytical Operations Outsourcing and Compliance
AbbVie
9 hours ago
Remote friendly (North Chicago, IL)
United States
Operations
Responsibilities:
- Manage outsourcing activities as the single point of contact for internal project teams, QA, business operations, procurement, and the external service provider.
- Coordinate, plan, and monitor outsourced analytical work to external and internal service providers.
- Manage outsourced analytical work packages from request through quote, contract, testing order, coordination of analyses, to invoice verification to meet timelines and budget.
- Support monitoring of service providers and identification/qualification of new external partners.
- Author, verify, and archive documents in a GMP environment.
- Work with different areas to develop a standardized, compliant, and effective global outsourcing process.
- Support management of investigations at external and internal service providers.
- Act as a change owner following the applicable CM process.
- Provide necessary QCC support for outsourced analytical work.
- Develop/align local processes/workflows and GMP approaches within PDS&T LC and global processes in cooperation with other PDS&T sites and partner organizations.
Qualifications:
- Bachelor’s degree (typically 10 years’ experience), Master’s degree (typically 8 years’ experience), or PhD (no experience required).
- Thorough theoretical and practical understanding of own scientific discipline.
- Minimum 3 years of pharmaceutical industry experience with exposure to analytical and/or formulation development and expertise in GMP.
- Knowledge of GMP requirements and regulations.
- Self-motivated, self-reliant, hard-working; able to work in a fast-paced global environment.
- Learns fast; adapts quickly to manage priorities and timelines.
- Pays attention to quality and detail.
- Strong communication and collaboration skills.
- Demonstrated problem-solving skills.
- Proficient with MS Excel, PowerPoint, Word, Power BI.
- Flexibility to handle changing timelines and shifting work priorities.
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) for eligible employees.
- Eligible for short-term incentive programs.
- Manage outsourcing activities as the single point of contact for internal project teams, QA, business operations, procurement, and the external service provider.
- Coordinate, plan, and monitor outsourced analytical work to external and internal service providers.
- Manage outsourced analytical work packages from request through quote, contract, testing order, coordination of analyses, to invoice verification to meet timelines and budget.
- Support monitoring of service providers and identification/qualification of new external partners.
- Author, verify, and archive documents in a GMP environment.
- Work with different areas to develop a standardized, compliant, and effective global outsourcing process.
- Support management of investigations at external and internal service providers.
- Act as a change owner following the applicable CM process.
- Provide necessary QCC support for outsourced analytical work.
- Develop/align local processes/workflows and GMP approaches within PDS&T LC and global processes in cooperation with other PDS&T sites and partner organizations.
Qualifications:
- Bachelor’s degree (typically 10 years’ experience), Master’s degree (typically 8 years’ experience), or PhD (no experience required).
- Thorough theoretical and practical understanding of own scientific discipline.
- Minimum 3 years of pharmaceutical industry experience with exposure to analytical and/or formulation development and expertise in GMP.
- Knowledge of GMP requirements and regulations.
- Self-motivated, self-reliant, hard-working; able to work in a fast-paced global environment.
- Learns fast; adapts quickly to manage priorities and timelines.
- Pays attention to quality and detail.
- Strong communication and collaboration skills.
- Demonstrated problem-solving skills.
- Proficient with MS Excel, PowerPoint, Word, Power BI.
- Flexibility to handle changing timelines and shifting work priorities.
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) for eligible employees.
- Eligible for short-term incentive programs.