Compliance Auditor - Direct Hire!

Kelly Services
Salisbury, MD
Aug 06, 2022
Aug 16, 2022
Full Time
Kelly is pleased to offer a **Direct Hire** opportunity for a **_Compliance Auditor_** with a premier employer in Salisbury, MD! This position can be remote or on-site in Salisbury, MD. Qualified candidates must have experience as a lead auditor and knowledge of quality systems within a pharmaceutical or FDA-regulated environment. Schedule:** Monday-Friday, 8am-5pm**Salary:** Competitive with a fantastic benefits package!**POSITION SUMMARY**The Compliance Auditor is a highly visible operational position of the Corporate Quality Compliance Team. The role of the Compliance Auditor is to ensure that the company is adhering to all GMPs, FDA Regulations and Guidelines, state, federal, and local laws applicable to the business. The incumbent manages the Internal Audit and Vendor Audit Programs for GMP, GDP and GLP compliance, working closely with the operational functions to define and review processes, procedures, and systems to be audited annually. The incumbent coordinates and develops with GXP operational groups and Quality Systems a holistic Quality auditing strategy.**Essential Functions:**+ Creates and executes a systematic approach to conduct all audits presenting findings and recommended changes to procedures or practices that are not in compliance with stated regulations and provides technical assistance to implement a plan to address such changes.+ Schedules and conducts internal and external audits.+ Manages and maintains the Internal Audit and Supplier/Vendor qualification program, including associated SOP's, Approved Vendor List, and Vendor Quality Agreements reporting metrics to Site, Department and Quality management.+ Completes and submits Internal and Supplier Audit reports.+ Leads internal and vendor GMP, GDP and GLP audit.+ Analyze potential risks within specific areas in order to avoid compliance issues.+ Performs general risk assessment studies to gauge the possible risk potential of vendors as required escalating critical findings to Corporate and Quality management.+ Responsible for reviewing progress toward closure of audit findings and reporting the progress to appropriate management. Performs follow-up on all supplied information in order to perform verification checks on proposed corrective actions.+ Supports readiness of the facility for Regulatory Inspection.+ Ensures timely completion of commitments from regulatory agency inspections and partner audits related to audit programs.+ Completes department related Change Controls, CAPAs and Deviations.+ Reviews and evaluates Internal and Vendor audit responses to determine acceptability of the response and any applicable CAPA plans.+ Performs follow-up activity to ensure effective CAPA implementation that resolves and documents issues pertaining to the internal and supplier audits.**Education**+ Bachelor's degree in related professional technical or life sciences degree/field or equivalent combined education and experience.**Industry Experience Required**+ Minimum five (5) years of related experience, must include extensive knowledge of quality systems within a pharmaceutical or FDA-regulated environment.+ Extensive experience in conducting vendor and internal audits.+ Experience in dealing with regulatory authorities desired.For immediate consideration, please email your resume to\#P1**Get a complete career fit with Kelly** **(R)** **.**You're looking to keep your career moving onward and upward, and we're here to help you do just that. Our staffing experts connect you with top companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in your career.**About Kelly** **(R)**At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center.Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.