Position Summary & Responsibilities:
The normal working hours for this role are 3rd shift, Sunday - Thursday from 10:00pm - 6:30am.
The primary purpose of this position is the timely preparation, delivery, and set-up of quality, complex chemical media to Card Production. The role requires current training including curriculum procedures, workstation organization, cleaning, establishing a safe work environment, housekeeping, and maintenance functions in the production department.
Responsibilities:
- Perform all work in the Production Department safely, in accordance with company policies and procedures.
- Perform and document complex manufacturing steps and verification as described in company procedures/policies, including but not limited to:
- Ensure media and/or sub-component preparation is completed accurately and timely for prompt product delivery based on production schedule.
- Conduct filtrations, including checks to ensure all filters function properly per procedure.
- Verify proper labeling, manufacturing, and storage of all media based on regulatory and Master Formulary specifications.
- Operate equipment such as steam kettles and perform Clean-In-Place (CIP) operations.
- Set up media dispense with high speed and accuracy, including setting pump dispense volume, placing dispense head, and verifying connections and bag numbering.
Assist with end-of-lot documentation review for Device History Record, Master Formulary, etc., following all documentation procedures and policies.Report scheduling or product availability issues in MES to management or scheduler and remain flexible to unplanned changes.Ensure all equipment is calibrated and operational before manufacturing tasks, and report any repairs needed immediately.Maintain adequate inventories of lab supplies and inform the purchasing resource when additional items are needed, following FEFO for stocks, broths, and chemicals.Participate in new product development and support transition from R&D to production as required.Maintain reliable attendance and punctuality.Perform other duties as assigned by management.Education, Skills, & Experience:
- Bachelor’s degree in a scientific field required; Biology or Chemistry preferred, or
- Associate’s Degree with 2+ years of wet chemistry or bench work, or
- High School Diploma/GED with 4+ years of wet chemistry or bench work experience.
- At least one year of wet chemistry or bench work experience preferred.
- Ability to work effectively toward goals with high accuracy in a complex environment.
- Excellent problem-solving, time management, and laboratory skills.
- Ability to work independently and in teams.
- Knowledge of sterile techniques and general laboratory procedures.
- Understanding of GLP/GMP and ISO guidelines.
- Strong PC skills including MS Office; SAP knowledge is a plus.