Principal Quality Auditor

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. We hold ourselves to the highest quality and regulatory standards.

Requirements

• Bachelor’s degree required (Science or Engineering preferred)
• Minimum 5-8 years of Quality, Compliance, Manufacturing, Engineering or Technical Services experience.
• Quality auditing experience in cGMP environments with experience in aseptic manufacturing environments.
• Independent auditor certification required (e.g., ASQ CQA, RAPS RAC, or ISO lead auditor).
• Extensive working knowledge of applicable quality and regulatory standards and regulations. Expertise in global GMP regulations.
• Excellent communication skills – both written and oral.
• Work effectively independently and in team environment.
• Must demonstrate sound judgment, problem-solving, and analytical skills to enable assessment of risk.
• Strong courage of conviction, conflict resolution, interpersonal and influencing skills.
• Ability to build relationships across functional boundaries at multiple levels internally/externally.
• Ability to demonstrate strong organizational and project management skills.
• Good working knowledge of Windows based applications.
• Resourceful, self-reliant, self-motivated and confident.
• Working knowledge of quality software systems (e.g. Veeva Vault).
• General knowledge of Lean Six Sigma and other continuous improvement tools.

Benefits

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan