Manufacturing Operator

Details:

The Formulation Team Leader is responsible for providing supervision for the RBC Formulation Team at MTS, and is focused on ensuring flawless execution against the
Quality System to ensure regulatory compliance with client’s global policies, international law and guidance.

The scope of the role includes but is not limited to the supervision of formulation operators. ·

Oversee the daily Formulation scheduled activities at MTS as required to support Operations including creating weekly formulation schedules
and delivery of intermediate buffers, diluents and solutions to be used in the manufacture of Reagent Red Blood Cells.

Performs the formulation, filtration and testing of solutions, buffers and diluents used in the preparation of Reagent Red Blood Cells, and ensures these products meet specifications.

Will coach and mentor other associates in these duties.

Responsible for and perform inspection, preventative maintenance and calibration of instrumentation in the department.

Perform timely review of batch records and forms to ensure solutions, buffers and diluents are available in a timely manner

Review forms for clarity and completeness ensuring the timely production release of components for further manufacturing.

Participates in daily management team meetings and collaborates with Materials Management, Product Support, Facilities Management, Manufacturing, Quality Control
Parameter Description Engineering to identify potential areas of process and product variability.

Addresses Non-Conformances (NC's), Investigations, Root Causes Analysis by completing on time investigations in the Change Control System.

Leads OOS Investigations and Document Revisions. Participates in all projects and initiatives undertaken at the MTS Site as a representative for the RBC Formulation department.

Directs activities to ensure the RBC Formulation department is in a continued state of compliance and inspection readiness.

Participate in Internal and External (FDA, TUV, and other Regulatory Agencies) Audits and represent the RBC Formulation department as a Subject Matter Expert.

Perform transactions in the SAP Inventory System and other systems used in support of RBC manufacturing.

Perform other work-related duties as assigned by the Department Manager.

Job Description:

The Individual Required Skills:

A minimum of An Associate of Science Degree in Medical Technology, Biology, Chemistry or Science related field of study and a minimum of 2-year experience at a medical or manufacturing facility.

Any combination of education and experience.

Experience working with chemical/biological formulations.

Excellent oral and written communication skills.

Basic knowledge of Microsoft Office suite of products (Excel, Word, Outlook).

Ability to prioritize and manage multiple tasks and challenges at the same time.

Work independently and within a team environment.

Preferred Skills:

Experience working in an FDA regulated environment.

Experience in leading teams in a manufacturing environment
The Work Environment A GMP licensed biologics manufacturing facility. Works primarily in the Formulation Department. Weekends and Overtime may be required.

The Physical Demands:

Frequent standing and sitting Close visual acuity required.

Room temperature laboratory with refrigerators of 2°C to 8°C.

Protective equipment such as gloves, safety glasses, lab coat and vinyl aprons required as needed.

Exposure to chemicals and biohazardous materials.

Works primarily within the formulation department.

Job Type: Contract

Pay: $20.00 - $23.00 per hour

Work Location: In person

Salary : $20 - $23