SRG, the leader in the Life Sciences human capital industry, is looking for a full-time permanent Quality Assurance Auditor to join their client's team in Lancaster, SC. The Quality Assurance Auditor reports to the Director of Quality. This role is responsible for developing and maintaining a strong Internal Compliance program ensuring compliance to applicable regulations. The QAA is required to perform internal and external audits, prioritize audit schedules and corrective actions to the findings identified.

JOB RESPONSIBILITIES include, but are not limited to:

• Manage audit planning, scheduling, and execute internal and external audits for South Carolina and Maryland Facilities to assess compliance to the regulations.
• Audit external suppliers (CMO's) and maintain the vendor qualification program including the Approved Vendor List.
• Determine the level of risk of findings identified and follow up on corrective actions ensuring they address the short-term correction as well as the preventive action of the finding.
• Develop and implement a performance tracking system and reporting of departmental compliance.
• Support training and readiness for regulatory inspections.
• Provide support to the South Carolina and Maryland Quality Assurance team.
• Review and Release CMO batch records and assist with in house batch release as needed.
• Familiar with QA functions in SAP.
• Manage the supplier corrective action request program (SCAR).
  

WHAT YOU NEED TO HAVE:

• 5 years of Quality Assurance auditing experience in cGMP environment with a minimum of 5 years of external vendor/ supplier compliance auditing experience within an FDA regulated industry.
• Direct experience in pharmaceutical, food, or medical device industry.
• Knowledge of the Regulations 21CFR Part(s) 210, 211, 507 as well as the Dietary Supplement Regulations 21 CFR 111 is required.
• ASQ Certified Auditor (CQA) Certification is required.

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.