Quality Systems Senior Specialist
AbbVie
3 days ago
Remote friendly (North Chicago, IL)
United States
$84,500 - $162,000 USD yearly
Operations
Sr Specialist Quality Systems
Responsibilities:
- Provide quality assurance support for pharmaceutical products, medical devices, combination products, and biologics (e.g., Document Center, Device QA, Labeling, Validation, Training, CAPA).
- Ensure product/process/system quality activities from raw material inspection through shipment comply with corporate and governmental regulations.
- Integrate and support quality regulations (drug, biologics, device and/or combination products).
- Assist project teams with planning, preparation, review, and approval of quality documentation.
- Develop a process to maintain citation history.
- Monitor legislative/regulatory changes impacting record retention and the AbbVie Record Retention Schedule.
- Create quality system documentation/specifications with guidance and approved templates.
- Complete and route change requests for process document creation, maintenance, and implementation.
- Design effective quality systems/procedures/processes within cross-functional teams; may prepare/present data for regulatory and internal audits.
- Interact with internal/external partners to develop quality system best practices.
- Perform compliance assessments to identify gaps and implement improvements.
- Contribute to training and education programs for quality assurance.
Qualifications:
- Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area (preferred).
- 5+ years’ experience in quality assurance/quality oversight (or relevant experience).
- Technical knowledge in Quality, Regulatory, Process Sciences, Manufacturing Operations.
- Familiarity with product/process/equipment/facilities for pharmaceutical, biological, or device-related products.
- Knowledge of QA systems and GMP compliance requirements and standards affecting device, biologics, and pharmaceutical products.
- Ability to work independently and in teams; manage own time with guidance.
- Strong oral and written communication.
- Excellent interpersonal skills (plus).
- Runs/manages small to medium quality-related projects.
Responsibilities:
- Provide quality assurance support for pharmaceutical products, medical devices, combination products, and biologics (e.g., Document Center, Device QA, Labeling, Validation, Training, CAPA).
- Ensure product/process/system quality activities from raw material inspection through shipment comply with corporate and governmental regulations.
- Integrate and support quality regulations (drug, biologics, device and/or combination products).
- Assist project teams with planning, preparation, review, and approval of quality documentation.
- Develop a process to maintain citation history.
- Monitor legislative/regulatory changes impacting record retention and the AbbVie Record Retention Schedule.
- Create quality system documentation/specifications with guidance and approved templates.
- Complete and route change requests for process document creation, maintenance, and implementation.
- Design effective quality systems/procedures/processes within cross-functional teams; may prepare/present data for regulatory and internal audits.
- Interact with internal/external partners to develop quality system best practices.
- Perform compliance assessments to identify gaps and implement improvements.
- Contribute to training and education programs for quality assurance.
Qualifications:
- Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area (preferred).
- 5+ years’ experience in quality assurance/quality oversight (or relevant experience).
- Technical knowledge in Quality, Regulatory, Process Sciences, Manufacturing Operations.
- Familiarity with product/process/equipment/facilities for pharmaceutical, biological, or device-related products.
- Knowledge of QA systems and GMP compliance requirements and standards affecting device, biologics, and pharmaceutical products.
- Ability to work independently and in teams; manage own time with guidance.
- Strong oral and written communication.
- Excellent interpersonal skills (plus).
- Runs/manages small to medium quality-related projects.