Job Description

One of our large pharmaceutical clients in Malvern, PA is seeking a Laboratory Compliance & Training Associate to join their growing team supporting the Biologics (large molecule) organization within R&D. This role will roughly be 30% training activities and 70% compliance activities. This individual will be responsible for supporting audits and quality investigations, providing training on LIMS systems and internal workflows for team members, completing lab walk throughs to ensure audit and inspection readiness, reviewing and revising training plans and material, supporting corrective and preventative actions and document management as well as generating reports and communicating findings to stakeholders and management teams. This position has a hybrid schedule of 3 days onsite a week and may require occasional travel to their Spring House location as well for any additional needed audit support or team meetings. Other responsibilities include:

• Providing support for investigations (non-conformance, deviations, invalid assays) and regulatory compliance for onsite teams
• Detect and communicate trends, gaps in processes or systems based on current and future regulatory requirements.
• Updating training plans and working with the process owners on needed training material
• Manage change through change control process and support internal and external audits
• Supporting metrics and quality systems for change controls and investigations
• Provide input and make decisions at cross-functional meetings and provide leadership and insight as a member of global project teams

Qualifications:

• Minimum of a Bachelor's Degree in a scientific discipline
• 1+ years of GMP Quality Assurance or Compliance experience (ideally for lab-based teams)
• Minimum of 2 years of experience navigating LIMS
• Prior training experience is a plus
• Ability to work onsite in Malvern 3-5 days/week when needed
• Experience supporting audits and investigation activities is a plus

Salary: $60,000-$70,000 (can be flexible based on experience)

Hours: Monday-Friday, 8:00am-5:00pm

Hybrid Schedule: 3 days onsite & 2 days remote a week

Hiring Method: Multiyear contract – After 1 year on contract, the individual will have the opportunity to apply for a permanent role or have their contract renewed for another year

PTO : 10 PTO days, 6 paid sick days annually & paid Holidays

Benefits: Medical, Dental, Vision and 401K plans available

Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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