Compliance Specialist

Title: Compliance Specialist

Location: PA-Malvern

Job Description: Job Description

One of our large pharmaceutical clients in Malvern, PA is seeking a Compliance Specialist to join their growing team supporting the Biologics (large molecule) organization within R&D. This role will be roughly compromised of 30% training activities and 70% compliance/quality assurance 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 in Malvern and 2 days remote. Occasional travel to their Spring House location may be required 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

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

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Skills and Requirements

• Minimum of a Bachelor's Degree in a scientific discipline
• 2+ years of related investigation and/or compliance experience in a GMP laboratory
• Experience performing change controls, assessing risks, executing plans in accordance with approved plan
• 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
• 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 -Experience conducting end to end investigations and defining corrective action plans
• Comet or TrackWise experience
• Project management experience null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.