Audit Specialist II, Regulatory Compliance

Responsibilities:
Manages regulatory compliance initiatives and projects across multiple LHP sites. Assesses FDA and DEA site readiness and strategically targets improvement observations to prepare for Agency visits. Conducts plant, system, SOP, and vendor audits; ensures strict adherence to cGMPs and SOPs. Reviews and analyzes operation documentation to assure material meets specification. Consults with Senior LHP management on 21 CFR 211 quality and regulatory compliance issues as directed from manager.
Conducts and helps oversee plant, FDA system, SOP, and vendor audits; ensures strict adherence to cGMPs and SOPs. Consults with, and influences management to take corrective action. Initiates and manages key compliance projects and timelines across multiple LHP sites to continuously maintain a state of FDA readiness for OTC/Rx Agency inspections including identification and execution of key compliance expectations.
Interacts and works with external inspector/auditors on investigations.
Performs vendor audits, as required. Assists management in conducting formal procedural inquires and investigations to determine the cause of quality problems, and recommends verbal and/or written corrective action and process improvements to management as required. Includes cGMP training and documentation issues, CAPA issues, and plant FDA readiness issues. Performs other related duties as assigned by Regulatory Affairs management.

Minor travel required, such as vendor audits, seminars and site visits.
REQUIREMENTS
Qualifications:
Two-year degree in a science-related field. Five years Regulatory Affairs, Quality Assurance or related industry experience required. Good understanding and working knowledge of cGMPs, MRP and PC required. Strong written and verbal communications skills required. Organizational skills, computer proficiency, and project management skills required. Ability to work independently and in a team environment. Ability to interact and professionally represent LHP with external inspectors and auditors. ASQ-CQA must be completed within one year of employment with LHP, if not already certified.

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