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Job Description
Simtra BioPharma Solutions is seeking a Filling Group Leader to join their Manufacturing Leadership Team. This role involves providing direct support to manufacturing, ensuring finished products meet specifications, and coordinating activities of Filling Operators. The Filling Group Leader will make decisions and provide oversight to ensure compliance with regulations and Simtra Standard Operating Procedures. This position supports quality operations and communicates effectively with team members and management.
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.
- Assisting in establishing and orienting new projects for production.
- 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
- 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
- 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, and Hospital Indemnity Insurance
- Identity Theft Protection
- Legal assistance
- Onsite Campus Amenities
- Workout Facility
- Cafeteria
- Credit Union
