Senior Quality Assurance Specialist

Pfizer • Rochester, MI

415d • $78,000 - $130,000

About The Position

The Senior Quality Assurance Specialist at Pfizer plays a crucial role in ensuring the quality and compliance of clinical and commercial drug batches. This position involves evaluating product and process documents, identifying deviations from established standards, and approving investigations and change control activities. The specialist will contribute to the quality assurance team by managing projects, conducting investigations, and maintaining regulatory compliance, ultimately impacting patient safety and product effectiveness.

Requirements

• High School Diploma with 8 years of relevant experience, or an Associate's degree with 6 years of experience, or a Bachelor's degree with at least 3 years of experience, or a Master's degree with more than 1 year of experience.
• Experience in Quality administered systems.
• Knowledge of current Good Manufacturing Practices and applicable GxP regulations.
• Proactive approach and strong critical thinking skills.
• Ability to work in a team environment.
• Excellent communication and interpersonal skills.
• Good working knowledge of Microsoft Excel and Word.

Responsibilities

• Evaluate and review clinical and commercial batches of drugs.
• Ensure product and process documents match specifications based on established procedures.
• Identify deviations from established standards in manufacturing and packaging.
• Approve investigations and change control activities to ensure compliance with policies.
• Conduct investigations for the Quality Operations group.
• Utilize investigation decision tools for various departments.
• Provide quality oversight and review for site-wide investigations.
• Manage own time to meet agreed targets and develop work plans for projects.
• Suggest improvements and conduct continuous improvement activities.
• Assess Change Control activities for potential quality impacts.
• Document Quality Assurance related deviations and escalate issues as necessary.
• Maintain regulatory compliance in accordance with current Good Manufacturing Practices.
• Provide Quality Review and oversight of site cGXP documentation.
• Review and approve validation documents and master batch records.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Paid vacation
• Paid holidays and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED