Manager, QC Bioassay
Job Description
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, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients.
Your understanding of Quality Control (QC) instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from Research and Development (R&D).
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 {also 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.
- Oversee project management of all Data Integrity related activities with the relevant teams.
- Address and resolve any potential issues with regulatory impact.
- Develop and maintain alignment with current industry best practice related to cleanroom techniques and share with the respective teams.
- 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.
Qualifications
Must-Have
- Applicant must have a High School Diploma (or Equivalent) with 10+ years of relevant experience;
- OR an Associate's degree with eight years of experience;
- OR a Bachelor’s degree with at least 5+ years of experience;
- OR a Master’s degree with more than three years of experience;
- OR a Ph.D. with 0+ years of experience.
- Experience in Quality Control
- Extensive knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, application of compendial methods and experience with a wide range of analytical techniques
- Experience with plate-based assays, ELISA, PCR, etc.
- 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
Nice-to-Have
- Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.
PHYSICAL/MENTAL REQUIREMENTS
- Must be able to stand for one to two hours throughout the day.
- Must be able to lift 40 lbs.
- Must be able to sit in front of a computer for 2 or more hours throughout the day.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- No travel required.
- This role is primarily day shift, Monday – Friday, with 24/7 support of manufacturing as operational issues arise.
- Additional hours are worked as needed to keep up with deliverables.
Other Job Details
Work Location Assignment:On Premise
Relocation Assistance Available: NO
Last date to apply: 11/10/2024
The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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.
