Shift Lead- Sr. Analyst, Quality Control

Use Your Power for Purpose

What You Will Achieve

In this role you will:

• Lead and manage the Monday-Friday Shift of up to 5 QC Analyst I/IIs 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 bachelors degree with at least 2 years of experience; OR a masters degree with 0 years of experience; OR an associates 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

• Ability to drive continuous improvement initiatives

PHYSICAL/MENTAL REQUIREMENTS

Physical:

• Requires many hours standing walking sitting bending lifting working at lab bench/BSC

• Able to don cleanroom gowning to access manufacturing area when necessary

Mental:

• Energy enthusiasm & capability to lead a shift drive continuous improvement and deliver on site goals

• Excellent leadership influence and interpersonal skills

• Willingness to share ideas to learn and to be challenged

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

• Work Location Assignment: On site must adhere to safe laboratory work practices and procedures including demonstrated aseptic technique and aseptic gowning.

• Work schedule may include off shift hours evening weekend holidays and/or on-call work may be required

• Limited travel no more than 10%

Work Location Assignment:On Premise

Relocation assistance may be available based on business needs and/or eligibility.