Regulatory Compliance Specialist
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The Compliance Specialist performs activities to ensure quality and compliance with applicable internal and regulatory requirements. These activities may include conducting internal audits, hosting customer audits and health authority inspections, and maintaining quality metrics as part of the Quality Management System. As a subject matter expert, the role holder will create (or assist with the creation of) the applicable Quality Management System documentation such as SOPs, training materials or investigation reports. Depending on experience, may serve as the lead auditor for external audits as well.
This role will also support the Regulatory Affairs team, as necessary, in filing various regulatory documentation and may be required to interact with US and international regulatory authorities.
Key Job Responsibilities:
Essential Job Requirements:
We invite all qualified applicants to apply. We offer competitive salary, a comprehensive benefits package and opportunity for advancement.
Alcami is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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