One of our large pharmaceutical clients is looking to hire a Compliance Specialist to join their Quality Assurance team in Malvern, PA. This position requires an individual to be on-site in Malvern. The individual will be preparing for and supporting external GMP audits and inspections for the Health Authority, Customer, ERC, etc. Additionally, they will be providing compliance subject matter expertise to the manufacturing sites and site-based projects.
Main responsibilities will include:
Quality Compliance:
-Support internal and external audit preparation and execution for the Malvern JSC site.
-Accurate Quality Review of Quality Agreements ensuring compliance to local and global procedures. Coordinate review by stakeholders.
-Coordinate Gap Assessment process at the site. Coordinate SME gap assessments, track updates required at a local level. Complete required documentation based on the assessments following global procedures.
-Schedule, run, and participate in mock recall activities including the facilitation of any meetings and follow-up as the process completes.
-Assist in compiling of information for the Site Quality Risk Register. Update presentations and assist with gathering information.
-Assist in writing and editing procedures and quality investigations
-Assist in compiling the Site Master File, coordinate SME updates and reviews, final document compilation
Training Assistance may include:
-Facilitate the asynchronous Train the Trainer module by grading submittals and providing guidance/feedback to trainees.
-Edit training modules
-Create courses in SUMMIT
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 opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their 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 or uniformed service member status, 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
HR@insightglobal.com.
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-QA or RA certification is preferred.
-Large molecule experience
-Experience supporting internal or external audits is preferred.
-Experience working with the Health Authority for inspections
Benefit packages for this role will start on the 1st 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.