Formulation/Filling Team Leader

Singota Solutions•Bloomington, IN

4d•Onsite

About The Position

Team Singota fosters a high-trust, high-accountability environment where individuals are supported and valued. The company culture emphasizes respect, support, and genuine enjoyment of work, leading to a passionate, dedicated, and efficient team. This role is within the Manufacturing department and is a full-time, non-exempt position with 40 hours per week on the first shift.

Requirements

Computer experience necessary.
Proficiency with Microsoft Office (Outlook, Excel, Word).
Attention to detail and good organization skills mandatory.
Ability to work in both collaborative and independent work situations and environments.
Job requires gowning to work in cleanroom environments.
Ability to stand for a minimum of 4 hours.
Must have good documentation practices with clear, legible handwriting.
Excellent work ethic and attention to detail.
Ability to communicate clearly, both written and verbally.
Requires repetitive hand, wrist, arm motions.
Hand eye coordination and manual dexterity with small components.
Use of small tools and laboratory/production equipment.
Clear, legible handwriting.
Able to comprehend and execute complex written instructions.
Must be able to lift, push, or pull up to 50 pounds.
Positive attitude and good judgment.
Good time management and organizational skills.
High school diploma with minimum 5+ years industry experience (or similarly regulated industry)
Ability to use basic lab instruments, such as; pH meter, conductivity meter, pipets.
Ability to use basic manufacturing equipment, such as; biosafety cabinets, mixers, pumps, filter testers.

Nice To Haves

Experience using equipment HMIs, as well as ERP or inventory systems desired.
Associates Degree in an Engineering or Science discipline (desired).
Bachelor’s degree in an Engineering or Science discipline (desired).

Responsibilities

Lead and play a major role in the onboarding of new operators in the area of assignment.
Provide back-up to Manufacturing Supervisors.
Serve as a Subject Matter Expert (SME) in the area of assignment.
Own, draft, and revise area procedures.
Lead sub-groups when projects require additional time outside of standard manufacturing shift hours, when necessary.
Work within the FDA regulated environment per 21CFR 210/211 requirements and those established by internal policy and standard operating procedures.
Participate in and fully support process improvement initiatives.
Adhere strictly to all safety requirements, including wearing proper PPE (personal protection equipment) while performing operations, i.e. respirator, safety glasses, gloves, etc.
Perform cleaning/disinfecting/sanitization of cleanrooms.
Assist in process investigations, writing of deviations, and implementation of CAPAs to continuously improve operations.
Provide recommendations and implement solutions to resolve equipment and/or process problems in a timely manner.
Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes and procedures.
Perform general support required of a company where everyone is expected to perform multiple tasks both inside and outside their department to meet the needs of the business.
Function as the subject matter expert (knowledge, skills) in assigned departmental area (i.e. Formulation/Filling, Sampling and Dispensing, Finishing); in alignment with manager’s directions.
Precision weighing and measuring of buffers, excipients, API, etc.
Install machine change parts and load recipes on fill machine.
Staging/loading of components and preparation of fill path.
Perform cleaning and VPHP decontamination of isolators.
Assist with environmental monitoring.
Label and package filled drug product and/or pharmaceutical components per written specifications, SOP’s, job aids and batch records.
Inspect product and printed materials for defects.
Responsible for reconciliation of all controlled printed materials and product.
Setup and operation of labeling and packaging equipment and systems.
Preparation and use of precision measuring instruments.