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Systems Administrator - Alachua Onsite

External
strivepharmacy logoStrivepharmacy · Alachua, FL
$85K–$95K/yrFull-timeOn-site1w ago
AccessibilityAzureComplianceDNSIAMLeadership
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Responsibilities

  • GMP Computerized Systems Administration
  • Serve as the site's primary technical owner and system administrator for all GMP-regulated computerized systems, including the EMS, BMS, CMMS/CCMS, LIMS, QMS and any EBR or MES platforms.
  • Ensure all regulated systems maintain a Validated State in accordance with GAMP 5 guidelines; coordinate with Validation on system categorization and risk-based validation approaches.
  • Maintain and manage Audit Trails, electronic signature configurations, and user access controls on all 21 CFR Part 11-regulated systems, ensuring records meet ALCOA+ standards.
  • Support the CSV lifecycle: author or review URS, FDS, Configuration Specifications, and execute IQ/OQ protocols for new systems, upgrades, and patches.
  • Manage the Periodic Review program for all validated computerized systems, ensuring scheduled reviews are completed on time and documented in accordance with SOPs.
  • Participate in Change Control for all IT changes affecting GMP-regulated systems; complete IT impact assessments and ensure no unauthorized changes are made to validated systems.
  • Site IT Infrastructure & Network Management
  • Support the on-site network architecture including LAN/WAN, VLANs, network segmentation between OT and IT environments, firewalls, DNS, DHCP, QoS, and ZTNA.
  • Support and maintain networks; ensure network topology supports both office and manufacturing floor connectivity without compromising GMP system integrity.
  • Support OT/IT network segmentation to isolate process control systems (BMS, EMS, SCADA, PLC networks) from corporate IT infrastructure, reducing cybersecurity risk to regulated manufacturing systems.
  • GMP Cybersecurity & Data Integrity
  • Implement and maintain cybersecurity controls aligned with FDA cybersecurity guidance for pharmaceutical manufacturing environments; ensure patch management programs do not inadvertently invalidate GMP systems.
  • Manage identity and access management (IAM) for all site systems using tools such as Okta, Windows Active Directory or Azure Active Directory; enforce RBAC and least-privilege principles across all GMP and non-GMP systems.
  • Maintain secure, GMP-compliant BDR procedures for all regulated systems; document and periodically test recovery procedures as part of the BCP.
  • Ensure all electronic records stored in GMP systems are protected against unauthorized modification, deletion, or access, in accordance with 21 CFR Part 11 and internal data int

Benefits

Health insurance

Additional Information

Company Overview Before we opened Strive Pharmacy we were unsatisfied with the current state of the pharmaceutical industry. Most of the current pharmaceuticals only offer a one size fits all approach and often come with unwanted and potentially dangerous side effects. We found that through compounding we can offer a much more personalized solution to medicine. Through this we have been able to help patients get the results they are seeking for their personal needs. After years of working for corporate chains we took the risk and opened Strive Pharmacy. We are dedicated to providing a better experience for each customer and clinic that we work with. Come see the Strive difference. Our Mission We're flipping the script with personal medicine. We strive to interrupt an industry that has been closed to personalized care, accessibility, and nuance for too long. We strive to shift a reactive view of self-care and ignite a proactive baseline-shifting approach to health for all. 'The human element' is our crux and catalyst, driving all that we do, whether we're interacting with patients, providers, or practices. We're here to partner with those ready for a change. More than a compounding pharmacy, we're on a mission to positively disrupt healthcare as we know it. Strive is about more than medicine. Strive is about striving for the personal side of healthcare. Position Type: Full-Time Location: Alachua, FL (on-site Monday - Friday day shift) Salary: $85,000 - $95,000 Travel: up to 25% Position Overview: The IT Systems Administrator serves as the dedicated, on-site technology leader for Strive Pharmacy's 503B outsourcing facility in Alachua, Florida. This is a high-impact, hands-on role at the intersection of information technology and pharmaceutical manufacturing compliance. The successful candidate will own the full IT infrastructure stack for the site while simultaneously acting as the primary technical owner for all GMP-regulated computerized systems - including the EMS, BMS, CMMS/CCMS, LIMS, and QMS. Unlike a traditional systems administrator role, this position requires a deep understanding of FDA 21 CFR Part 11 electronic records requirements, GAMP 5 CSV principles, and the data integrity standards that govern a regulated pharmaceutical environment. The IT Systems Administrator partners directly with Quality, Engineering, Validation, and Operations leadership to ensure that every computerized system is validated, audit-ready, and operating in a continuous state of compliance.


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