SENIOR ASSOCIATE, IT SYSTEMS ADMINISTRATOR
BILLERICA, MA (ONSITE & 20% - 30% TRAVEL)
Our client is looking for a Senior Associate, IT Systems Administrator who manage their day-to-day System Administration, user support and implementation of GxP Computerized Systems in QC Analytical Lab Manufacturing and other regulatory operations including, but not limited to, networked and non- networked standalone instruments, firmware-based instruments, HMI’s, SCADA systems and any GxP application software at any manufacturing site across the North America region.
WHAT YOU GET TO DO
- Collaborate with business partners in various functions, instrument vendors, and other IT team members to implement, perform applications administration and support GxP applications and systems in a controlled laboratory, manufacturing, and other regulatory functions. This includes, but not limited to maintaining GxP Systems Inventory, User Access Management – activation, modification and deactivation of users, managing user access privileges, implementation and/or retirement of GxP systems, ensuring that Backup of all GxP systems is being taken, Recovery of GxP systems when required and any other related activity assigned by IT Management through application of cGMP principles and following internal standard operating procedures (SOPs), work instructions (WIs), and regulatory requirements.
- Provide support during new systems implementation, overseeing design or configuration and validation (IQ / OQ/ PQ) to ensure the solutions will meet business needs while adhering to IT policies and procedures, compliance standards, and GxP requirements.
- Conduct Periodic Reviews such as but not limited to User Access Management, Systems Validation Reviews, SOP Reviews etc. to confirm computerized systems are compliant with company procedures and regulatory agency guidelines and requirements.
WHAT YOU BRING
- Minimum of a Bachelor's Degree. Preference will be given to a candidate having a bachelor’s degree in Life Sciences, Pharmacy, Computer Science or Computer Information Systems (CIS) or related field.
- Minimum 6-7+ years of hands on experience maintaining, administering GxP systems, applications, instruments and shop floor machines in a manufacturing and/or quality function with detail orientation and strong problem solving, analytical, and critical thinking skills.
- Excellent understanding of GAMP 5, 21 CFR Part 11, Computer System Validation and Quality Management System.
- Experience in Empower 3, UV/VIS, FTIR etc.
- Knowledgeable in User Access / Privileges and System Support.
- Requires travel for up to 25%-30% of the work hours.
COMPENSATION AND BENEFITS
- Salary range is between $120,000 to $140,000 based on experience and qualifications, as well as geographical market and business considerations.
- +10% bonus
- 3 weeks paid vacation
- 401(k) match