Compliance Specialist - Insight Global

Job Title: Compliance Specialist

Hire Model: 12-month extending contract

Work Model: Hybrid Flex (3-5 days/week on-site in Malvern, PA)

Pay Rate: $43.00-$50.00/hr

One of our large pharmaceutical clients in Malvern, PA is seeking a Sr. Compliance Specialist to join their growing team supporting the Biologics (large molecule) organization within R&D. This person will be responsible for supporting audits, driving nonconformance investigations, risk analysis, corrective and preventative action records, document management, assay trending, root cause analysis, and human performance factors analysis. This position requires analytical thinking, organizational leadership, and strong written and verbal communication skills.

Other responsibilities include:

• Independently run investigations (non-conformance, deviations, invalid assays)
• Identify gaps in processes or systems based on current and future regulatory requirements and communicate necessary changes to leadership and appropriate stakeholders
• Risk assessments
• Author and execute corrective and preventative action record and execute CAPAs when required
• Track deviations and provide reports to management on trending, and status as requested. Recommend corrective actions for any trends identified.
• Manage change through change control process and support internal and external audits
• Keep track of regulatory requirements and changes and perform Gap Assessments as needed
• Provide input and make decisions at cross-functional meetings and provide leadership and insight as a member of global project teams
• Process improvement

Required Skills & Experience

• Minimum of a Bachelor's Degree in a scientific discipline
• 5+ years of related GMP investigation and/or compliance experience in the pharmaceutical/life sciences industry
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) and ability to identify gaps in processes or systems based on current and future regulatory requirements
• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols is required
• Strong communication skills and ability to work with multiple internal and external stakeholders in a matrixed environment at a global scale
• Ability to work onsite in Malvern 3-5 days/week

Nice to Have Skills & Experience

• Comet or TrackWise experience
• Project management experience

Compensation:

$43/hr to $50/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Healthcare benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, financial protection benefits, as well as HSA, FSA, and DCFSA account options. 401k retirement account access is offered starting on the 90th day with employer matching after one year of service. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.