Sr QA Specialist

Description

Key Responsibilities :

Apply critical thinking and risk-based judgment to address routine and complex manufacturing challenges, and ensuring continuous improvement.

Review and approve documentation and records related to drug substance manufacturing activities, including batch records, materials management, cleaning, and analytical data.

Provide support for manufacturing investigations, including deviations, CAPAs, and change controls associated with production processes.

Participate in authoring, reviewing, and approving SOPs, forms, and controlled documents to ensure compliance with GMP requirements.

Provide QA oversight during manufacturing operations and collaborate with cross-functional teams to resolve issues promptly.

Support internal and external audits, inspection readiness, and continuous improvement initiatives at the site.

Actively participates in Quality System improvement and harmonization activities, including electronic system implementation.

Engage in Quality Risk Management activities to assess and mitigate risks in site operations.

Provides guidance and mentorship to others in the Quality group.

Qualifications :

• Bachelors degree in chemistry, or a related field, and 6+ years of relevant experience in a GMP environment OR
• Masters degree in chemistry, or a related field, and 4+ years of relevant experience in a GMP environment OR
• PhD degree in Chemistry, or related field, with O+ years of experience

Preferred Qualifications :

Advanced degree preferred

Experience working in a GMP environment an asset.

Must be able to think critically and creatively, solve routine to complex problems, work independently, and have strong organizational and planning skills.

Experience with analytical method development, verification, validation and transfer

Knowledge of GMP regulations, including ICH Q2, Q7, Q9, Q10 is preferred.

Experience across broad areas of Quality Assurance and / or Quality Control Systems is preferred.

Demonstrated ability to develop, coach and mentor employees is an advantage.

Experience in Quality Risk Management activities is preferred.

Excellent interpersonal, verbal, and written communication skills

Knowledge of Six Sigma, DMAIC methodology, risk management tools, and / or quality improvement statistical tools would be an asset.

For Current Gilead Employees and Contractors :

Please apply via the Internal Career Opportunities portal in Workday.