Simtra BioPharma Solutions · 3 days ago
Principal Quality Auditor
Bloomington, IN
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expSimtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies. The Principal Quality Auditor conducts internal audits to ensure compliance with cGMP regulations, manages regulatory inspections, and serves as a technical expert within the Quality Auditing department.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Perform internal audits by collecting and analyzing objective evidence regarding issues and risks. Report findings to management team
Host and manage regulatory inspections and corporate audits, including the response process and corrective action tracking
Host and manage audits conducted by the company's contract manufacturing clients
Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Communicate issues to management team
Manage the tracking, reporting, positioning, adequacy of actions, verification, closeout, and trending of audit-related corrective and preventive actions
Manage the assessment file through the process to closure
Perform follow-up audits to confirm corrective and preventive action is effective
Remain current in regulatory knowledge through attendance at related conferences, seminars, meetings, and other training methods such as independent study of periodicals, industry sources, Internet or other literature
Prepare management reports depicting trends for management review purposes
Manage and maintain the risk-based internal audit schedule. Act as a leader for the internal audit program
Lead continuous improvement initiatives for the Quality department
Act as а mentor/coach to other auditors, subject matter experts, and new hires
Serve as designee for Sr Manager, Quality Auditing
Conduct and report on gap assessments against regulations, guidances, regulatory findings, and Corporate procedures
Perform Compliance/Standards Impact Analyses for Change Control
Perform Quality approval and Periodic Review for Standard Operating Procedure revisions that impact Quality Compliance
Qualification
Required
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
Preferred
Experience with risk management and root cause analysis preferred
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 and more
Adoption Reimbursement Program
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program
Employee Ownership Plan
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
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
1001-5000 employees
H1B Sponsorship
Simtra BioPharma Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
Funding
Current Stage
Late StageTotal Funding
$0.5M2024-12-19Grant· $0.5M
Leadership Team
M
Mike Schaefers
Chief Commercial Officer (CCO) & Head of Business Development
Recent News
Inside INdiana Business
2025-09-23
Company data provided by crunchbase