Simtra BioPharma Solutions · 1 day ago
Quality Documentation Specialist
Bloomington, IN
Full-time
Onsite
Entry Level
2+ years expSimtra BioPharma Solutions is a leading Contract Development Manufacturing Organization focused on delivering sterile injectable products. The Quality Documentation Specialist is responsible for compiling batch manufacturing documentation, managing the documentation process, and ensuring compliance with regulatory requirements while providing customer service to internal teams.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Perform assigned tasks related to Veeva and ERP system for batches
Perform batch record review for GMP support sections produced at Simtra for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc
Reconcile discrepancies with documentation and/or electronic systems as appropriate
Compile documentation packets for batch manufacturing, including printing of controlled forms and other serialized or controlled documentation that is not part of the effective manufacturing batch record
As needed during operations, generate additional batch documents for batches in progress. This may include supplemental batch record sections, controlled forms, and documents of other types
Manage the process of sign-out and sign-in of batch records
Manage the process of correction resolution, assisting personnel with controlled access to executed records requiring documentation corrections
Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Quality review of batch records in order to achieve internal targets and contractual commitments for batch release
Participate in continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction
Qualification
Required
Associates degree or 2 years of similar relevant experience
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, etc.)
Preferred
Experience with documentation and/or quality control systems preferred
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
2026-01-22
2026-01-20
Company data provided by crunchbase