Simtra BioPharma Solutions · 3 months ago
Aseptic Observer Program Lead
Bloomington, Indiana, United States
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. They are seeking an Aseptic Observer Program Lead to design and implement quality systems and training programs for the Aseptic Observation program, ensuring quality oversight of aseptic filling operations.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Responsible for design and continuous improvement of the Aseptic Observer Program (aseptic manufacturing quality oversight)
Responsible for improvement and standardization of the QALO training program, including incorporation of industry and regulatory intelligence
Responsible for improvement and standardization of the QALO training program, including incorporation of industry and regulatory intelligence
Develop strong partnership with QALO cell teams, manufacturing training, sterility assurance, QC microbiology and other stakeholders in program
Organize collected data from Aseptic Observer Program, analyze trends, lead cross functional review meetings, and make necessary improvements with operations leadership based on observations
Act as member of Contamination Control Strategy team
Present aseptic observation program data to site and executive leadership in management review forums, including trending and improvements made
Hire, train and develop QALO trainers
Qualification
Required
Bachelor's Degree in scientific or related discipline required
Minimum 5 years of experience in a pharmaceutical or biotech industry required
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, etc.)
Ability to work in sterile environment with aseptic gowning requirement
Preferred
Excellent oral and written communication skills
Previous technical writing experience including documentation, Change Controls, CAPAs, SOP, Regulatory observation responses
Deviation management, review and writing
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
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