IT Systems Administrator, Senior Associate

Software Guidance & Assistance, Inc., (SGA), is searching for an IT Systems Administrator, Senior Associate for a Direct Placement assignment with one of our premier Pharmaceutical Services clients in Billerica, MA .

Responsibilities :

• Manage 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
• 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
• Assist with QMS processes within IT, especially change control impact assessments, CAPA execution and managing deviations and incidents through root cause analysis for GxP systems changes
• Propose alternate processes, procedures and process automation pathways to streamline and increase effectiveness and efficiency of IT operations
• Collaborate with various stakeholders globally and/or across the sites within the region to understand and implement best GxP IT practices
• Support regulatory, customer and other such audits from IT department

Required Skills:

• 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.
• Excellent understanding of GAMP 5, 21 CFR Part 11, Computer System Validation and Quality Management System.
• Experience with Empower software a must- Empower3 is highly preferred
• Excellent collaboration and communication skills.
• Ability to manage competing priorities and flexibility to shift workload when needed.
• Excellent written and verbal communication skills and working knowledge of Microsoft Office Applications.
• A team player with ability to work with people at all levels and diverse skill sets.
• Requires travel for upto 25%-30% of the work hours.
• Experience 5-7+ Years total IT experience with a Minimum of 3+ years of hands on experience maintaining, administering GxP systems
• Applications experience
• experience with instruments and shop floor machines in a manufacturing and/or quality function with detail orientation and strong problem solving, analytical, and critical thinking skills.

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy.