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Job Description
Simtra BioPharma Solutions is seeking a Manufacturing Group Lead for Aseptic Filling on the 2nd shift at their Bloomington, Indiana facility. This role is a member of the Manufacturing Leadership Team and reports to the Manufacturing Supervisor. The Filling Group Leader will coordinate activities of Filling Operators, ensure compliance with regulatory guidelines and Simtra SOPs, and drive quality operations on the production floor. They will also communicate effectively with team members, management, and other departments.
The role involves:
- Delegating, coordinating, and scheduling activities of assigned team members.
- Recommending measures to improve performance and increase efficiency.
- Training and mentoring other team members.
- Troubleshooting process problems and responding to process alarms.
- Participating on Continuous Improvement teams.
- Assisting in developing/reviewing batch records of new and existing projects.
- Reviewing project plans and batch records prior to operations; monitor assigned team’s documentation in logbooks and batch records.
- Organizing and coordinating general cleaning and sanitizations throughout all filling suites.
- Identifying potential causes and verify/eliminate each one to determine the true root cause behavior
Requirements:
- Ability to work independently
- Good communication skills
- Good documentation skills, including legible handwriting
- Good interpersonal skills
- Basic computer skills
- Basic math skills
- Knowledge of aseptic manufacturing practices
- Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
- High school diploma or GED required
- 6 months of previous Pharmaceutical or Manufacturing experience preferred.
Simtra BioPharma Solutions offers:
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D 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
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Voluntary Insurance Benefits
- Onsite Campus Amenities
- Workout Facility
- Cafeteria
- Credit Union
