Compliance Specialist

Job Title: Quality Assurance Specialist
Reports to: Sr. Manager, Quality Assurance & Regulatory Compliance
Location: South Bay
Job Grade/FLSA* Status: Exempt

General Summary:
Responsible for auditing site procedures to ensure compliance with current Quality System requirements. Provide feedback and potential resolution of any potential process/procedure gaps encountered. In addition, this position will also support the compliance in all other Quality System areas as required by Quality Management.
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Essential Functions:
* Leads and conducts internal audits.
* Proactively maintains the site Quality System integrity including documentation, policies and procedures.
* Ensure current site QMS system follows Good Documentation practices (CGMP), the required Quality System (QS) regulations, company policies and procedures.
* Identification, reporting and proposing of potential solutions to Quality Management for any potential issues or process improvements encountered during daily activities.
* Participate in tracking, assigning, investigating and closing Corrective and Preventive actions.
* Participates in other Quality Projects as required by Quality Management

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