Simtra BioPharma Solutions
Manufacturing Group Lead- Capping (Weekend PM)
Simtra BioPharma Solutions, Bloomington, Indiana, United States, 47401
The Capping 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 Capping Operators who perform in the manufacturing areas. The Capping Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to 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 Capping Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.
The responsibilities
Delegate, coordinate, and schedule activities of assigned team members.
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.
Initiate exception reports as required.
Organize and coordinate general cleaning and sanitizations throughout all capping suites. Efficiently identify potential causes and verify/eliminate each one to determine the true root cause behaviors
Examine documents/processes (SOPs, equipment, methods, etc.) to prevent errors and/or recognize unexpected results.
Required to maintain attendance in accordance with the Bloomington Attendance Policy
Scheduled weekend overtime will be required
The work environment Classified pharmaceutical environment wearing required gowning as shown in attached document. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.
Ability to work independently
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
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
Physical / safety requirements
Occasional (0-33%) — Sitting, climbing stairs and ladders, balancing, stooping, kneeling, crouching, operating controls
Lifting and carrying up to 52 lbs
Pushing and pulling up to 22 lbs
Frequent (34-66%) — Standing, walking, reaching forward and overhead
Lifting and carrying up to 35 lbs
Pushing and pulling up to 24 lbs
Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping
Additional requirement(s)
High school diploma or GED required
6 months of previous Pharmaceutical or Manufacturing experience preferred
Final candidates for Capping 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
In return, you’ll be eligible for
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 and more
Adoption Reimbursement Program
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program
Employee Ownership Plan
Additional Benefits
Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more
Onsite Campus Amenities
Workout Facility
Cafeteria
Credit Union
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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The responsibilities
Delegate, coordinate, and schedule activities of assigned team members.
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.
Initiate exception reports as required.
Organize and coordinate general cleaning and sanitizations throughout all capping suites. Efficiently identify potential causes and verify/eliminate each one to determine the true root cause behaviors
Examine documents/processes (SOPs, equipment, methods, etc.) to prevent errors and/or recognize unexpected results.
Required to maintain attendance in accordance with the Bloomington Attendance Policy
Scheduled weekend overtime will be required
The work environment Classified pharmaceutical environment wearing required gowning as shown in attached document. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.
Ability to work independently
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
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
Physical / safety requirements
Occasional (0-33%) — Sitting, climbing stairs and ladders, balancing, stooping, kneeling, crouching, operating controls
Lifting and carrying up to 52 lbs
Pushing and pulling up to 22 lbs
Frequent (34-66%) — Standing, walking, reaching forward and overhead
Lifting and carrying up to 35 lbs
Pushing and pulling up to 24 lbs
Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping
Additional requirement(s)
High school diploma or GED required
6 months of previous Pharmaceutical or Manufacturing experience preferred
Final candidates for Capping 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
In return, you’ll be eligible for
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 and more
Adoption Reimbursement Program
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program
Employee Ownership Plan
Additional Benefits
Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more
Onsite Campus Amenities
Workout Facility
Cafeteria
Credit Union
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
#J-18808-Ljbffr