- 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 team. You will be responsible for evaluation, review and approval of lab computer system change controls, protocols and reports. Your methodological approach will help us ensure compliance of our quality systems with company standards and government regulatory requirements. Your problem-solving ability will help us troubleshoot validation problems for equipment and performance processes and conduct statistical analysis of testing results and process anomalies. Your documentation skills will guide the writing, review and approval of for validation process documents and technical reports related to lab equipment, products and processes.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It
Experienced lab validation professional responsible for the development, delivery, assessment and maintenance of site lab computer validation programs, documentation, and courses in support of the Validation Quality System.
Responsible for change management of lab computer validation systems.
Works effectively as a member of the Quality System team as well as directly with lab personnel, site Management, and SMEs to support Data Integrity and lab validation initiatives.
Partner directly with Lab Managers and SMEs to develop site level lab validation protocols, reports and change controls.
Deliver / Facilitate training directly related to the lab validation quality system as needed.
Review and approve change management and lab validation data.
Conduct and report assigned internal audits for lab validation in coordination with Audits and Inspections team.
May serve as Lab Validation Quality System SME during customer and regulatory audits and prepare requested documentation for lab equipment.
- Applicant must have eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience.
Demonstrated presentation skills to customers at various levels, with good written and verbal communication skills.
Candidate is required to have a sound understanding of GMPs and various types of validation and data integrity documentation (e.g. SOPs, User Guides, IQ/OQ, risk assessment).
Clear track record of effective teamwork, collaboration and communication, with demonstrated ability to work in a cross-functional team environment.
Strong organizational and prioritization skills to handle multiple items with changing deadlines.
Strong critical thinking and analytical skills with high attention to detail
Ability to manage change and deal with ambiguity.
Proficiency with Microsoft Outlook, Excel, PowerPoint.
Lab equipment validation experience including but not limited to writing and executing lab validation protocols and reports.
Demonstrated use of Data Integrity principles and concepts.
Familiarity with PDOCS for document storage and QTS for change management is preferred.
Work Location Assignment:Flexible
Last Date to Apply for Job: August 16, 2022
- Eligible for Relocation Package: Yes
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.
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.
Quality Assurance and Control