Formulation Group Leader, 3rd Shift

https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&view=0  https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&view=0   https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&view=0  https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&view=0  https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&view=0 https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&view=0 https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&view=0 https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&view=0  https://myfiles.baxter.com/personal/jennifer_kelley_baxter_com/_layouts/15/onedrive.aspx?id=%2Fpersonal%2Fjennifer%5Fkelley%5Fbaxter%5Fcom%2FDocuments%2FMfg%20%26%20Pkg%20Headcount%20Spreadsheet%2FJob%20Descriptions%20%2D%20updated%20Sept%202022&FolderCTID=0x012000528BCFFB620F504ABB278BA37B147F04&view=0           This role:  The Formulation 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 Formulation Operators who perform in the manufacturing areas.  The Formulation 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 Formulation Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.   The responsibilities:             Prepare media and buffer solutions Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems Operate general production equipment (such as pH and conductivity meters, autoclaves, portable mixers, scales and balances, etc) Monitor and record critical process parameters Complete all relevant paperwork following GDP/GMP guidelines Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion Perform sampling using aseptic techniques Participate on Continuous Improvement Teams Train and mentor other team members Write, revise and review pertinent documentation as appropriate Troubleshoot process problems and respond to process alarms Assist with process/equipment validation and data analysis Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion Required to maintain attendance in accordance with the Bloomington Attendance Policy Scheduled weekend overtime will be required   Work Environment:  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.   Desirable qualifications: To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions:  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 Physical / safety requirements: Occasional (1-33%) Sitting, climbing stairs and ladders, balancing, kneeling, operating controls Frequent (34-66%) Standing, walking, reaching forward and overhead, stooping, crouching, Pushing and pulling up to 110 lbs Lifting and carrying up to 70 lbs Constant (67-100%) 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 Formulation 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. Must be able to understand, speak, read and write English in order to comply with necessary SOP’, job-specific training materials, GMP’s, and other manuals.       In return, you’ll be eligible for[1]: Day One Benefits Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance Spouse Life Insurance Child Life 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 Short and Long-Term Disability Insurance 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 [1] Current benefit offerings are in effect through 12/31/26     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.     Equal Employment Opportunity 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.                                                                                                                                           Data Privacy To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy: https://simtra.com/privacy-policy/ Offices: Bloomington, Indiana, United States (Bloomington, IN);