Audit Specialist II, Regulatory Compliance

Position Overview:

Manages regulatory compliance initiatives and projects across multiple LHP sites.  Assesses FDA and DEA site readiness and strategically targets improvement observations to prepare for Federal Agency and 3rd party audits.  Conducts plant, system, SOP, and vendor audits; ensures strict adherence to cGMPs and SOPs.  Reviews and analyzes operation documentation to assure material meets specifications.  Advises senior management on 21 CFR Parts 110, 210 & 211 quality and regulatory compliance issues.

 

Position Responsibilities:

* Conducts and coordinates plant, FDA system, SOP, and vendor audits; ensures strict adherence to cGMPs and SOPs.  Consults with, and advises management on corrective actions.

* Initiates and manages key compliance projects and timelines at multiple LHP facilities to continuously maintain a state of FDA readiness for VMS/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 inquiries and investigations to determine root cause of quality problems; recommends verbal and/or written corrective actions and process improvements, including evaluation of 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.

 

Minimum 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.

 

PLEASE EMAIL YOUR RESUME AS A WORD ATTACHMENT TO DPATRICK@LEINER.COM .