Manufacturing Group Lead- Aseptic Filling (Weekend AM)

Simtra BioPharma Solutions • Bloomington, IN

92d

About The Position

The Filling Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor. They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Filling Operators who perform in the manufacturing areas. The Filling Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures. This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments. The Filling Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. Weekend PM 7am-7:30pm (Friday - Monday)

Requirements

• High school diploma or GED required.
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• 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.
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices.

Responsibilities

• Delegate, coordinate, and schedule activities of assigned team members.
• Recommend measures to improve performance and increase efficiency.
• Train and mentor other team members.
• Troubleshoot process problems and respond to process alarms.
• Participate on Continuous Improvement teams.
• Assist in developing/reviewing batch records of new and existing projects.
• Assist in establishing and orienting new projects for production.
• Review project plans and batch records prior to operations; monitor assigned team’s documentation in logbooks and batch records.
• Organize and coordinate general cleaning and sanitizations throughout all filling suites.
• Identify potential causes and verify/eliminate each one to determine the true root cause behavior.
• Required to maintain attendance in accordance with the Bloomington Attendance Policy.
• Scheduled weekend overtime will be required.

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
• 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 Insurance
• Critical Illness Insurance
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal Assistance
• Onsite Campus Amenities including Workout Facility, Cafeteria, and Credit Union

What This Job Offers

• Job Type: Full-time
• Education Level: High school or GED
• Number of Employees: 1,001-5,000 employees