Quality Control Senior Scientist I – Biologics Analytical Research & Development
AbbVie
9 hours ago
On-site
South San Francisco, CA
Operations
Responsibilities:
- Represent the QC function on cross-functional program teams.
- Collaborate with analytical leads to achieve release and stability program deliverables.
- Author quality documents and regulatory submission sections to enable regulatory submissions and clinical supply.
- Perform data verification.
- Trend stability data using JMP or other statistical software to support retest dating.
- Prepare and review quality control documents (e.g., Certificates of Analysis, method validation reports, reference standard qualification reports, release & stability protocols, stability reports).
- Initiate and review change records and quality event/change documentation in collaboration with Technical and Quality SMEs and stakeholders.
- Coordinate document workflows with authors, owners, stakeholders, and approvers to meet timelines.
- Ensure compliance with SOPs, standards, and requirements.
- Support internal and external audits and inspections.
- Serve as a subject matter expert for GxP quality system document management (formatting, electronic document management processing, document categorization/numbering, and approval).
Qualifications:
- BS (typically 10+ years relevant experience) or MS (typically 8+ years relevant experience).
- General understanding of analytical methods used for release and stability testing of protein therapeutics (monoclonal antibodies and antibody drug conjugates).
- Experience evaluating and trending GMP stability data for shelf-life assignment.
- Proficient in JMP (or similar) and LIMS systems.
- Experience authoring QC change records and exception reports.
- Solid understanding of test methods via hands-on lab experience.
- Strong GxP compliance knowledge.
- Plus: knowledge/hands-on experience with biopharmaceutical GxP electronic document management systems.
- High attention to detail; critical thinking; proactive and independently accountable.
- Strong data/time management and interpersonal communication skills.
- On-site role with daily face-to-face cross-functional interactions.
Benefits (if applicable):
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k).
Application instructions:
- Not provided in the job description text.
- Represent the QC function on cross-functional program teams.
- Collaborate with analytical leads to achieve release and stability program deliverables.
- Author quality documents and regulatory submission sections to enable regulatory submissions and clinical supply.
- Perform data verification.
- Trend stability data using JMP or other statistical software to support retest dating.
- Prepare and review quality control documents (e.g., Certificates of Analysis, method validation reports, reference standard qualification reports, release & stability protocols, stability reports).
- Initiate and review change records and quality event/change documentation in collaboration with Technical and Quality SMEs and stakeholders.
- Coordinate document workflows with authors, owners, stakeholders, and approvers to meet timelines.
- Ensure compliance with SOPs, standards, and requirements.
- Support internal and external audits and inspections.
- Serve as a subject matter expert for GxP quality system document management (formatting, electronic document management processing, document categorization/numbering, and approval).
Qualifications:
- BS (typically 10+ years relevant experience) or MS (typically 8+ years relevant experience).
- General understanding of analytical methods used for release and stability testing of protein therapeutics (monoclonal antibodies and antibody drug conjugates).
- Experience evaluating and trending GMP stability data for shelf-life assignment.
- Proficient in JMP (or similar) and LIMS systems.
- Experience authoring QC change records and exception reports.
- Solid understanding of test methods via hands-on lab experience.
- Strong GxP compliance knowledge.
- Plus: knowledge/hands-on experience with biopharmaceutical GxP electronic document management systems.
- High attention to detail; critical thinking; proactive and independently accountable.
- Strong data/time management and interpersonal communication skills.
- On-site role with daily face-to-face cross-functional interactions.
Benefits (if applicable):
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k).
Application instructions:
- Not provided in the job description text.