QC Product Lead (1st 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. The product lead in Quality Control (QC) Portfolio Management team is responsible for overseeing and coordinating the QC activities for assigned product(s).This role ensures that the QC activities align with organizational priorities, regulatory standards and compliance requirements. This role works closely with cross-functional teams including R&D, QA, manufacturing and regulatory affairs to ensure proper QC oversight as products are transferred from Pfizer R&D sites and implemented and maintained at the Sanford site.
This role is designed to be 100% on-site Monday to Friday 8am - 5pm.
**How You Will Achieve It**
+ Develop and implement strategies to effectively oversee QC activities for the assigned product(s), ensuring alignment with business goals and regulatory compliance.
+ Monitor performance of the assigned product(s) and provide regular updates to senior management on challenges and opportunities for improvement.
+ Coordinate with cross- functional teams to ensure QC projects are delivered on-time, within budget and to quality standards.
+ Assess resource requirements, training requirements, and equipment needs for the assigned program, and coordinate with laboratory management to allocate resources accordingly.
+ Collaborate with colleagues and subject matter experts to determine the most suitable analytical methodologies to support project initiatives, including the use of computational predictive tools, modeling software, and data visualization tools as necessary.
+ Prepare technical reports, critically review data, and evaluate new instrumentation and analytical techniques/approaches as required.
+ Independently analyze experimental data and provide conclusive insights.
+ Act as the primary point of contact from QC for the assigned product(s), ensuring transparent communication with stakeholders and communicating to the various QC groups the program needs.
+ Develop and maintain strong relationships with internal teams, including quality assurance, regulatory affairs and manufacturing.
+ Prepare and review necessary regulatory responses.
+ Prepare and review QC APRR sections for assigned programs.
+ Prepare and deliver presentations on assigned product(s) in various inter-departmental forums.
+ Mentor junior employees and offer technical guidance when required.
**Qualifications**
**Must-Have**
+ Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
+ Extensive hands-on experience and strong background in either Chemistry, Microbiology or molecular biology assays.
+ Experience with troubleshooting assays and improving method performance.
+ Strong technical writing and presentation skills.
+ Strong communication skills at multiple levels of management.
Nice-to-Have
+ Experience with method validation and method transfer skills to manufacturing site.
+ Experience with manufacturing process development.
+ Understanding of critical quality attributes of drug substance and drug product.
+ Experience in project management in a regulated environment.
+ Proficiency in project management tools and quality management systems.
Work Location Assignment: On Premise**Last Day To Apply: November 21st, 2024**
The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% 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.
Quality Assurance and Control
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