Simtra BioPharma Solutions
Contract Development Manufacturing Organization
FillingGroupLeaderWeekendPM
“Filling Group Leader Weekend PM at Simtra BioPharma Solutions. Skills: Decision-making, Oversight, Compliance to regulatory agency regulations and guidelines, Compliance to Simtra Standard Operating Procedures, Quality operations, Effective communication with production team members, multiple levels of management, and other customer support departments, Creating an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished prod”
What You'll Achieve.
Ensure that finished products meet the required specifications; Ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures; Drive quality operations on the production floor; Create an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product; Improve performance and increase efficiency
Industry & Context.
Solve problems in new ways; Troubleshoot process problems; Identify potential causes and verify/eliminate each one to determine the true root cause behavior
Required to work all designated plant holidays, Weekend PM Friday-Sunday 7:00pm-7:30am, Scheduled weekend overtime will be required, Classified pharmaceutical environment wearing required gowning, Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions, Must be able to occasionally (1-33% of the time) work in a confined/clustered work space, Occasional (1-33%) Sitting, climbing stairs and ladders, balancing, kneeling, operating controls, Lifting and carrying up to 70 lbs, Pushing and pulling up to 35 lbs, Frequent (34-66%) Standing, walking, reaching forward and overhead, stooping, crouching, Lifting and carrying up to 37 lbs, Constant (67-100%) Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping, Final candidates for Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job
What They're Looking For.
Must Have
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, Occasional (1-33%) Sitting, climbing stairs and ladders, balancing, kneeling, operating controls, Lifting and carrying up to 70 lbs, Pushing and pulling up to 35 lbs, Frequent (34-66%) Standing, walking, reaching forward and overhead, stooping, crouching, Lifting and carrying up to 37 lbs, Constant (67-100%) Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping, High school diploma or GED required
Nice to Have
6 months of previous Pharmaceutical or Manufacturing experience preferred
What You'll Do.
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
Provide decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures
Fully support and drive quality operations on the production floor
Communicate effectively with production team members
multiple levels of management
and other customer support departments
Create an environment where teamwork
and quality (SISPQ) are reflected in the finished product
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 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
Maintain attendance in accordance with the Bloomington Attendance Policy
Work all designated plant holidays
Work Weekend PM Friday-Sunday 7:00pm-7:30am
Scheduled weekend overtime will be required
How You'll Work.
Team & Collaboration
Work as one, respecting each voice and tapping into unique strengths across teams; Communicate effectively with production team members, multiple levels of management, and other customer support departments
Communication Scope
Good communication skills; Communicates effectively with production team members, multiple levels of management, and other customer support departments
Process & Methodology
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
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