Manager Quality System Administrator
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Job Location:
Kalamazoo, MI - USA
Monthly Salary:
$ 96300 - 160500
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 SMEs 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 PCs 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 PCs 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 bachelors degree with at least 4 years of
experience; OR a masters degree with at least 2 years of experience; OR
a PhD with 0 years of experience; OR as associates degree with 8 years
of experience; OR a high school diploma (or equivalent) and 10 years of
relevant experienceBroad 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 PCs 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.
Work Location Assignment:On Premise
The annual base salary for this position ranges from $96300.00 to $160500.00. In addition this position is eligible for participation in Pfizers 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 lifes 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 (). 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 providers 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 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. 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.
Required Experience:
Manager
Key Skills
- Active Directory
- VMware
- Computer Networking
- Microsoft Windows Server
- Solaris
- Windows
- Linux
- SAN
- Shell Scripting
- System Administration
- Dns
- CentOS
About Company
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