Position: Senior IT Systems Administrator Associate
Location: Billerica, MA
Overview: As a Senior Associate in IT Systems Administration, you will oversee the day-to-day management of GxP Computerized Systems within QC Analytical Lab Manufacturing and other regulatory operations. This includes handling networked and standalone instruments, firmware-based tools, HMI's, SCADA systems, and GxP application software across manufacturing sites in North America.
Responsibilities:
- Collaborate with stakeholders, instrument vendors, and IT colleagues to implement, administer, and support GxP applications and systems in controlled laboratory and manufacturing environments.
- Manage GxP Systems Inventory, User Access, and ensure compliance with cGMP principles and internal SOPs and regulatory requirements.
- Support new system implementations, ensuring alignment with business needs and adherence to IT policies, compliance standards, and GxP requirements.
- Conduct Periodic Reviews to ensure system compliance with company procedures and regulatory guidelines.
- Assist in QMS processes within IT, including change control impact assessments and managing deviations and incidents.
- Identify opportunities for process improvement and automation to enhance IT operations.
- Collaborate with stakeholders globally to implement best GxP IT practices.
- Support IT audits from regulatory bodies, customers, and other relevant parties.
Qualifications:
- Bachelor's Degree in Life Sciences, Pharmacy, Computer Science, or related field preferred.
- Strong understanding of GAMP 5, 21 CFR Part 11, Computer System Validation, and Quality Management System.
- Excellent collaboration and communication skills.
- Ability to prioritize tasks effectively and adapt to changing workloads.
- Proficiency in Microsoft Office Applications.
- Team player with the ability to work with individuals at all levels.
- Willingness to travel up to 25%-30% of the time.
Experience:
- 6-7+ years of hands-on experience maintaining and administering GxP systems, applications, and instruments in manufacturing and/or quality settings.
- Detail-oriented with strong problem-solving, analytical, and critical thinking skills.
