Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.
What You Will Achieve
In this role, you will:
The system administrator will act as the business system owner for all QO Lab Systems.
Oversight of the laboratory systems including Quality review and approval for all system documentation, granting and revoking access to lab systems, communication with BT and End Users, testing and troubleshooting issues and assuring compliance to data integrity expectations.
Assist laboratory operations with qualification of computerized laboratory equipment including Electronic Record / Electronic Signature assessments and laboratory system configuration documents.
Work with laboratory SME’s and laboratory system vendors to ensure that the systems allow for proper delineation of duties between users, power users, and administrators.
Creation and modification of user accounts, including role profiles when necessary, on computerized laboratory system software.
Group policy administration on local PC’s in accordance with data integrity requirements.
Assist laboratory with selection of new equipment with regard to data integrity compliance
Interface with BT and system vendors when required to add/troubleshoot laboratory system PC’s on the Pfizer network including network connections, software configuration, and anti-virus exclusions.
Perform periodic review of computerized systems for compliance with data integrity expectations.
Maintain working knowledge of administrative functions utilized by laboratory software.
Stay appraised of current industry trends in data integrity requirements including 21CFR, ICH, MHRA, and FDA guidance.
Utilize QTS for change management as well as document review and approval.
Participate in both regulatory and customer audits.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelor's degree with at least 4 years of
experience; OR a master's degree with at least 2 years of experience; OR
a PhD with 0+ years of experience; OR as associate's degree with 8 years
of experience; OR a high school diploma (or equivalent) and 10 years of
relevant experience
Broad knowledge of site business processes impacted by QO Lab Systems.
Capable of evaluating multiple solutions and viewpoints and driving toward the best outcome for the site.
Ability to effectively manage change and convey a compelling future vision.
Excellent written and oral communication skills and ability to effectively communicate with people at all levels of the organization.
Demonstrated planning and organizational skills.
Familiarity with site change control and investigation processes using QTS.
Proficiency in core computer software/systems (Excel, Word, PowerPoint, Sharepoint, etc.)
Candidate has familiarity with Windows based PC’s in regards to user profiles, group policies, and security settings.
Bonus Points If You Have (Preferred Requirements)
Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
Strong leadership and team management skills
Ability to work under pressure and meet tight deadlines
Ability to influence and negotiate with stakeholders
Experience in conducting internal audits and supporting regulatory inspections
PHYSICAL/MENTAL REQUIREMENTS
None.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
None.
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 endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.