Simtra BioPharma Solutions · 2 weeks ago
Sr Quality Auditor
Bloomington, IN
Full-time
Onsite
Senior Level
5+ years expSimtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies. The Senior Quality Auditor will be responsible for conducting internal audits to ensure compliance with cGMP regulations and managing regulatory inspections while serving as a technical expert in the Quality Auditing department.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Performs internal audits / assessments by collecting and analyzing objective evidence regarding issues and risks
Ensures that audit schedules are produced and communicated in a timely fashion
Plans, schedules, coordinates, supports, and leads detailed audits of facility practices to ensure that policies and procedures comply with worldwide regulatory agencies and Corporate Quality Policy guidelines
This includes review of updated GMP regulations and current FDA and outside of US requirements and incorporation into internal programs, where appropriate
Leads/supports Client audits of the facility
Prepares for the audit/assessment activity by researching background information, including previous audit results
Assists in reviewing audit responses
Maintains the assessment file through the process to closure
Supports routine GMP and Pre-Approval Inspection regulatory audits
Prepares for audits by coordinating documentation, arranging facility tours, reserving conference rooms, and communicating with facility subject matter experts
Assists in pre- and post- audit communications with Global Quality and regulatory bodies
Interfaces with regulatory inspectors during audits
Evaluates corrective and preventive action responses to assessment findings for adequacy, including root cause and timeliness
Conducting and confirming follow-up actions on Corporate, Client, Regulatory and Internal site compliance audits
Reports extended corrective actions to management
Performs procedure gap assessments to ensure compliance with Global Quality procedures
Maintains and makes recommendations for improvement to Quality procedures
Performs desktop evaluations of site’s suppliers per Global Quality procedures
Considered a Subject Matter Expert for department
Mentors other auditors
Trains subject matter experts for inspection readiness
Qualification
Required
Bachelors degree required. Preferably in a science or technical discipline
Minimum 5 years experience in the pharmaceutical industry, which should include at least 3 years of auditing experience
ASQ and/or RAB auditor accreditation is strongly desired
Extensive working knowledge of applicable quality and regulatory standards and regulations
Excellent communication skills – both written and oral
Work effectively independently and in team environment
Must demonstrate sound judgment and analytical skills to enable assessment of risk
Expertise in GMP regulations
Ability to demonstrate strong organizational skills
Good working knowledge of Windows based applications
Resourceful, self-reliant, self-motivated and confident
Working knowledge of quality software system (e.g. TrackWise, Veeva)
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