Position Summary & Responsibilities:
The normal working hours for this role are 2nd 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, including current training on curriculum procedures, work station organization, cleaning, and establishing a safe work environment. Responsibilities also include housekeeping and maintenance functions in the production department.
- 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:
- Ensure media and/or sub-component preparation is completed accurately and promptly based on the production schedule.
- Conduct filtrations, including checks to ensure filters function properly per procedure.
- Verify all media is appropriately labeled, manufactured, and stored following regulatory and Master Formulary specifications.
- Operate equipment such as steam kettles and perform Clean-In-Place (CIP) operations.
- Set up media dispense with speed and accuracy, including setting pump dispense volume, connecting dispense head, and verifying connections and bag numbering.
- Assist with end-of-lot documentation review for Device History Record and Master Formulary, ensuring all documentation follows procedures and policies.
- Report scheduling or availability issues with planned manufacturing in MES to management or scheduler. Remain flexible to abrupt changes due to unplanned circumstances.
- Inspect and ensure all equipment is calibrated and operational before manufacturing. Report and manage repairs immediately to prevent delays. Perform startup and shutdown procedures as described in company policies.
- Maintain adequate inventories of lab supplies and inform purchasing when additional items are needed. Manage stocks using FEFO for long-term stocks, broths, and chemicals.
- Participate in new product development and assist with transition from R&D to production as required.
- Maintain reliable attendance and punctuality, which are essential for this position.
- Perform other duties as requested 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 and/or bench work, or
- High School Diploma/GED with 4+ years of wet chemistry or bench work experience.
- Minimum of one (1) year wet chemistry and/or bench work experience preferred.
- Ability to work effectively toward goals while maintaining high accuracy in a complex environment with changing demands.
- Excellent problem-solving, time management, and laboratory skills.
- Ability to work independently and in teams.
- Knowledge of sterile techniques and general laboratory procedures.
- Familiarity with GLP/GMP and ISO guidelines.
- Strong PC skills (MS Office, SAP desired).