Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra? Because we:
Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.
Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.
This Role
The Research Associate II Quality GMP role maintains department quality systems and documentation archives, performs periodic compliance checks of laboratory systems and participates in audits. This role is 100% onsite at the Bloomington facility and reports to the Research Manager.
The Responsibilities
- Ensure all department paper and electronic GMP documentation is maintained and archived
- Lead LE&IS (Laboratory Equipment & Instrument Systems) projects and serve as System Administrator for laboratory systems
- Conduct periodic compliance checks of quality systems in the department
- Retrieve documentation for internal and client audits
- Maintain all department Standard Operating Procedures (SOPs)
- Act as Electronic Document Management System Specialist by responsible for creating job aides, assisting with training, etc.
- Initiate change control management (CCM) records for department
- Support departmental 6S (Six Sigma) activities
- Maintain all department labels and act as Electronic Labeling Management System (Robar) Specialist
- Maintain current knowledge of relevant quality and other regulatory requirements related to R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities
- Support instrumentation validations and/or periodic review of validations, study procedures, matrix reporting and act as electronic quality system (TCU) Process Owner for Analytical Method Validation
- Provide project oversight management of LE&IS Validation projects
- Support department quality related initiatives
Required Qualifications
- BS degree OR AS degree with 5 years experience in pharmaceutical quality role in lieu of a BS degree OR 10 years experience in pharmaceutical quality role(s) with no degree
- In-depth knowledge and understanding of GMP and related regulations and guidelines
- Detailed oriented and organizational skills
- Demonstrated experience in working independently and being a self-started
- Strong oral and written communication skills
- Intermediate proficiency in Microsoft Office Suite
- Ability to use Enterprise software system: JDE, TCU, Veeva Vault, ELN (Electronic Laboratory Notebooks), Trackwise, Smartsheets
In return, you’ll be eligible for [1]
: - Day One 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
- Additional Benefits
- 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
[1] Current benefit offerings are in effect through 12/31/24
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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