Shift Lead- Sr. Analyst, Quality Control

Use Your Power for Purpose

Pfizer’s North Creek Manufacturing Facility is clinical and commercial biologics manufacturing facility producing antibody and antibody drug conjugates for life-altering cancer treatments.   

The North Creek facility is seeking a highly motivated QC Shift Lead-Sr. Analyst that desires an opportunity to lead a team of Analyst I/II’s in the QC Microbiology laboratory, contributing to the development and commercialization of transformative cancer therapies. The focus of this role includes day-to-day oversight and performance of routine and non-routine facility/utility testing, in-process/release testing of commercial products in a cGMP microbiological testing laboratory.  This role requires both technical expertise in a cGMP microbiology laboratory and strong interpersonal skills such as communication and collaboration to lead, troubleshoot and proactively problem solve and improve efficiency.  Working in a fast-paced environment where learning and personal development are actively encouraged, you will find the role both challenging and rewarding. 

What You Will Achieve

In this role, you will:

• Lead and manage the Monday-Friday Shift of up to 5 QC Analyst I/II's, including the day-to-day oversight and performance of microbiological QC testing at North Creek

• Actively share knowledge and provide technical guidance and oversight to team members, fostering a collaborative environment, ensuring routine and non-routine facility and utility testing, in-process/release testing of commercial products in a GMP testing laboratory is performed per applicable standard operating procedures and test methods

• Identify and implement potential improvements in processes or products, taking calculated risks to develop innovative ideas

• Manage the performance of direct reports through goal setting, coaching, and ongoing assessment, recognizing the need for development, creating development plans, ensuring training is current and managed to plan, managing PTO and scheduling adjustments

• Communicate effectively by soliciting input, explaining complex concepts, and persuading others to adopt a point of view, while sharing own perspectives and rationale

• Approve investigations and change control activities, maintaining compliance with configuration management policies and overseeing site prioritization and management escalation meetings

• Develop and oversee inspection preparation plans for key Good Manufacturing Practices (cGMP) elements, providing Quality Assurance expertise and guidance to colleagues and external parties

• Manage spend to departmental budgets, control costs, interface with Regulatory Agencies during audits, and manage audit report distribution to ensure timely delivery of critical information and regulatory commitments

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience

• Working knowledge of current Good Manufacturing Practices (cGMP) for a pharmaceutical industry

• Highly organized with attention to detail

• Problem-solving skills that demonstrate the Pfizer values if excellence, equity, joy and courage

• Strong collaboration, relationship management, and interpersonal skills

• Strong people management experience

• Excellent written and oral communication skills

• Strong computer proficiency skills in MS Office, Word, Excel, Access, Project or equivalent

Bonus Points If You Have (Preferred Requirements)

• 6+ years of experience working in a GMP laboratory or advanced degree with 4+ years of experience working in a GMP laboratory

• Excellent organizational and time management skills

• Experience in interfacing with regulatory agencies during audits