GxP Systems Support

Our client, a leading pharmaceutical manufacturing company, is seeking an experienced GxP Systems Support professional to join its team in Princeton, NJ. This onsite contract opportunity is ideal for candidates with experience supporting GxP-regulated systems and applications within a pharmaceutical or life sciences environment. The role will support critical business functions by ensuring GxP systems remain compliant with regulatory requirements while providing technical support, system administration, and quality documentation assistance. Candidates with a strong understanding of computer system validation, quality management systems, and FDA regulations are encouraged to apply., * Collaborate with team members and business partners in various GxP functions such as Quality Control Lab, Manufacturing, Packaging etc. to:

• Provide support on a variety of GxP applications including, but not limited to, user access management, periodic reviews and other assigned activities in line with the regulatory agency expectations and organization’s SOPs,
• Perform GxP assessments as mandated by the Quality unit or Regulatory Agencies.
• Resolve reported issues in a compliant and a timely manner.
• Ensure that all support and administration activities are executed in alignment with regulatory expectations, 21 CFR Part 11requirements and the organization’s SOPs.
• Assist with QMS processes and documentation related to 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 in GxP areas.
• Support regulatory, customer and other such audits from IT department.

• 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 of 5 years of experience in a similar environment.
• Proven ability to support instrumentation applications such as Trackwise, OpenText D2, LMS, Empower3, LabX, FTIR, UV/Vis or similar.
• Excellent understanding of GAMP 5, 21 CFR Part11, Computer System Validation and Quality Management System.
• Ability to multi-task, 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.

Pulled from the full job description

• 401(k)
• Health insurance, * Integrity
• Commitment
• Quality
• Diversity

Benefits for eligible employees

• Direct deposit
• Weekly pay
• Medical benefits
• 401(k) Plan

We are a fast growing and successful agency that treats all its clients and candidates with a personal touch. ProStaff Workforce Solutions is a group of industry experts-many hailing from larger agencies-who know their business well and enjoy working in a more hands-on and flexible environment, with attention to detail. Our mission is to match quality people with quality jobs and quality companies to maximize productivity and profitability. We develop long-term relationships and provide a level of customer service and expertise that instill confidence and trust in our client companies and candidates.