Element Staffing Services ยท 2 days ago
Quality Assurance Auditor (FDA-regulated)
Lancaster, SC
Full-time
Onsite
Senior Level
$70K/yr - $95K/yr
5+ years expElement Staffing is recruiting for a Quality Assurance Auditor for a client in the Lancaster SC area. This role is responsible for developing and maintaining a strong Internal Compliance program ensuring compliance to applicable regulations, performing internal and external audits, and managing audit schedules and corrective actions.
Bookkeeping and PayrollEmployee BenefitsEmploymentRecruitingStaffing Agency
Hiring Manager
Dave Hurt
Responsibilities
Manage audit planning, scheduling, and execute internal and external audits for Nutramax Laboratories to assess compliance to the regulations
Audit external suppliers (CMO's) and maintain the vendor qualification program including the Approved Vendor List
Manage external vendor(s) responsible for international audits
Manage the Nutramax supplier corrective action request program (SCAR)
Manage all documents relating to audits, vendors, and suppliers in a QMS (Qualityze)
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
Prioritize work to ensure that audits and reports are completed in a timely manner. Support implementation of CAPA program where necessary
Train and assist internal departments to understand and comply with Quality and Compliance expectations
Assess internal audit process by identifying and prioritizing areas of the business where there is a risk of non-compliance and assist in development and/or execute processes or policies to reduce that risk
Support training and readiness for regulatory inspections
Provide support to other Quality Assurance team members
Report audit metrics to Quality Assurance and department management
Communicate effectively with all levels of the organization and departments within the organization and function within a team environment
Understand the roles and responsibilities of the Contract Manufacturing Organizations and provide Quality Assurance support
Review and Release CMO batch records and assist with in house batch release as needed
Familiar with QA functions in SAP
Perform other assigned duties as may be required in meeting Quality Assurance and company objectives
Qualification
Required
Must have a minimum of 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
Knowledge of the Regulations 21CFR Part(s) 210, 211, 507 as well as the Dietary Supplement Regulations 21 CFR 111 is required
Must be proficient Computer Software applications including MS office suite
Must be able to stand, walk, push, and pull in a variety of environments including a Manufacturing and clean rooms
Must have the ability to wear all required Personal Protective Equipment (PPE) based on the auditing environment
Must be able to travel 20 - 30% for domestic audits, (International travel may be needed per quality management)
B.A. or B.S. in Science or Technical field required
Preferred
ASQ Certified Auditor (CQA) Certification is preferred
Company
Element Staffing Services
Element Staffing Services is a scientific and technical staffing company offering direct placement and payroll services.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Jake Broussard
President
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