Quality & Regulatory Specialist - Lab Packaging - Franklin, NJ

Regulatory Compliance SpecialistSupport regulatory compliance activities and help ensure adherence to applicable industry regulations and standards. Maintain regulatory documentation, product records, and technical files. Assist with regulatory submissions, change notifications, and responses to regulatory agencies. Monitor changes in regulations and communicate potential impacts to key stakeholders. Support product registration activities and lifecycle management processes. Review validation protocols, reports, and risk assessments to ensure compliance requirements are met. Coordinate validation activities with internal teams and external partners. Maintain and improve Quality Management System (QMS) processes and documentation. Review and support quality records, deviations, CAPAs, change controls, and risk assessments. Participate in investigations related to non-conformances, customer complaints, deviations, and other quality events. Support supplier qualification activities, supplier audits, and quality performance monitoring. Assist with customer, internal, and regulatory audits and ensure timely resolution of audit findings. Contribute to continuous improvement initiatives that strengthen quality and compliance performance.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.The Successful ApplicantHigh school diploma or Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Chemical Engineering, or a related scientific discipline. 1-5 years of experience in Quality Assurance, Regulatory Affairs, or a regulated manufacturing environment. Experience within pharmaceutical, biotechnology, medical device, or similarly regulated industries is preferred. Working knowledge of cGMP requirements and regulatory frameworks including FDA, EMA, and ICH guidelines is advantageous. Familiarity with Quality Management Systems, CAPA, deviations, change control, and risk management processes. Exposure to audits, inspections, and compliance programs is preferred. Experience supporting validation activities such as equipment qualification, process validation, cleaning validation, or computerized systems validation is a plus. Strong analytical, problem-solving, and organizational skills. Excellent written and verbal communication abilities. High attention to detail with a commitment to documentation accuracy and quality standards. Ability to manage multiple priorities and collaborate effectively across departments.What's on OfferCompetitive compensation and comprehensive benefits package. Opportunity to work within a global organization operating in a highly regulated industry. Exposure to regulatory affairs, quality systems, validation, and compliance initiatives. Collaborative and supportive working environment. Professional development and career advancement opportunities. High level of cross-functional exposure and visibility across the business. The chance to make a meaningful impact on quality, compliance, and continuous improvement efforts.