Senior Auditor - Supplier Quality
December 13
Description
• Simtra BioPharma Solutions is a Contract Development Manufacturing Organization. • The Sr Auditor executes supplier qualification activities in the Quality Auditing Team. • Focus on quality and regulatory standards in pharmaceutical manufacturing. • Collaborate across teams to enhance supplier quality processes.
Requirements
• Bachelor's degree required; with preference for a Science or Engineering field. • Minimum five (5) years experience in Quality, Manufacturing, or Engineering (Supplier Quality functions preferred). • Pharmaceutical, medical device, combination devices, and/or biologics industry experience highly preferred. • Experience auditing manufacturing facilities, laboratories, and computerized system vendors. • Experience in root cause analysis with quality tools, corrective and preventive action methods, data analysis and reporting. • Experience with Quality Agreement negotiations is a plus. • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise and eQMS software (examples include: TrackWise, JDE, Veeva, etc.) • Responsibilities require an estimated 35%-75% travel, including internationally. Flexibility for remote work while not performing supplier audits. • Travel requirements could include routine on-site visits to Bloomington, IN or Halle, Germany to collaborate with Simtra team members. • ASQ, ISO and/or RAB auditor accreditation is desired. • Knowledge of pharmaceutical regulations and international standards, e.g., ISO 13485, ISO 9001, FDA cGMP, Eudralex, other global aseptic manufacturing regulations. • Business Acumen; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her industry, business, and organization. • Collaboration and Teamwork: Good communications, facilitation, coordination, and team skills. • Project management skills managing multiple issues of moderate to high complexity relatively independently with minimal supervision/instructions. Multi-tasking skills in a demanding fast paced environment. • Ability to manage the Quality relationship with assigned key suppliers/stakeholders – Competence in supporting on-site / off-site supplier quality development including coordination / management of resources. • Superior written and oral communications skill sets.
Benefits
• Day One Benefits • Medical & Dental Coverage • Flexible Spending Accounts • Life and AD&D Insurance • Supplemental Life Insurance • Short and Long-Term Disability Insurance • 401(k) Retirement Savings Plan with Company Match • Time Off Program • Adoption Reimbursement Program • Education Assistance Program • Employee Assistance Program • Community and Volunteer Service Program • Additional Benefits • Voluntary Insurance Benefits • Vision Coverage • Accident • Critical Illness • Hospital Indemnity Insurance • Identity Theft Protection • Legal and more • Onsite Campus Amenities • Workout Facility • Cafeteria • Credit Union
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