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Job Description
Simtra BioPharma Solutions is seeking a Manufacturing Technical Services Representative to join their team. This role is crucial for technical and process improvement aspects of client projects, requiring direct interaction with clients and internal teams. The position is 100% onsite at the Bloomington facility.
The role involves:
- Authoring, maintaining, and revising commercial master batch records (MBR).
- Reviewing and releasing commercial batch records for production.
- Training manufacturing personnel on MBR changes.
- Investigating Non-Conformance Reports (NCR) and determining root causes.
- Authoring technical studies for investigations and process improvements.
- Managing client project updates and reviews.
- Participating in Business Review Meetings and client calls.
- Serving as a Subject Matter Expert (SME) in audits.
Requirements:
- BS degree in a science-related field.
- Familiarity with quality operating procedures and regulatory requirements.
- Strong communication and organizational skills.
- Proficiency in Microsoft Office Suite and enterprise software.
- Ability to qualify for Grade C areas.
Simtra BioPharma Solutions offers:
- Day One Benefits including Medical & Dental Coverage.
- Flexible Spending Accounts and Life Insurance.
- 401(k) Retirement Savings Plan with Company Match.
- Time Off Program including Paid Holidays and Parental Leave.
- Adoption Reimbursement and Education Assistance Programs.
- Onsite Campus Amenities including a Workout Facility and Cafeteria.
