Manager, QC Microbiology - Second Shift

Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer's dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, microbial identification, bioburden and sterility testing will help Pfizer provide safe drugs to patients.

Your understanding of Quality Control (QC) will help us meet their accuracy specifications against established standards.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It

• Manage multiple projects and ongoing work activities of moderate complexity within the division typically involving cross-functional representatives.
• Oversee and guide lab analysts on continuous improvement tools such as standard work and visual management.
• Review and approve documentation associated with Good Manufacturing Practices (cGMP), method validation, investigation of change controls and technical reports.
• Collaborate with site functional areas and customers to support site goals, objectives and timelines.
• Ensure alignment to all regulations and Pfizer Quality Standards related to area of oversight and work with other management teams to ensure support for all testing activities in the routine testing area.
• Provide oversight of Microbiology product testing group responsible for routine testing of product or process samples for endotoxin and bioburden.
• Oversee project management of all Data Integrity related activities with the relevant teams.
• Address and resolve any potential issues with regulatory impact.
• Represent area of responsibility at meetings and in audits.
• Provide information, discuss problem batches, manufacturing/technical issues, deviations and other events with potential impact on product quality and/or supply.
• Foster teamwork and colleague development, as well as change management, within the department and set up departmental metrics to achieve operation effectiveness.
• Review and approve incidents/investigations
• Serving as the point of contact for Weekend shift

Qualifications
Must-Have

• Applicant must have 10 years of relevant experience; OR an Associate's degree with eight years of experience; OR a Bachelor's degree with at least five years of experience; OR a Master's degree with more than three years of experience; OR a Ph.D. with 0-2 years of experience.
• Demonstrated experience in Quality Control
• Extensive knowledge of current Good Manufacturing Practices (cGMP) compliance requirements for Quality Control Laboratories, application of compendial methods and experience with a wide range of analytical techniques
• In-depth understanding of aseptic processing and monitoring procedures
• Reasoning ability including strong analytical and problem solving abilities
• Strong people management experience
• Strong verbal and written communication skills
• Collaborative nature that works well within a team environment and takes ownership of individual tasks/projects

​Nice-to-Have

• Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.
• Experience in microbiological assays such as sterility, bioburden, viable count, microbial ID.

Physical/Mental Requirements

• Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets
• Intellectual capability to perform complex mathematical problems and perform complex data analysis

Non-Standard Work Schedule, Travel, or Environment Requirements

• Work schedule is an alternate shift with priority covering second shift, Monday - Friday, 3pm - 11:30pm. May include work hours outside of scheduled shift to support business needs.

Relocation support available
Work Location Assignment: On Premise

Last day to apply: 9 FEBRUARY 2023

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

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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