Job Summary

Performs a variety of activities in the Serum Bulk Manufacturing department with a high degree of multi-tasking and attention to detail. These processes include but are not limited to cleaning and sterilization of containers used in production, processing raw material, dilution of solutions/diluents, dilution of final products, intermediate filtrations, and final filtrations. Performs certain production tasks in a clean environment in compliance with Good Manufacturing Practices and Good Documentation Practices.

Key Accountabilities

• Performs Serum Bulk Manufacturing processes according to corporate policies, operating procedures, specifications, and/or work instructions.
• Performs accurate calculation of product volumes and has work verified by another team member prior to proceeding.
•  Performs the preparation of diluents/solutions, product dilution, pre-filtration and post-filtration samples for culturing, unit weight determination.
• Prepares chemical solutions including weighing chemicals (both liquid and dry) and mixing components according to the SOP.
• Performs clerical checks for co-workers including but not limited to volume and weight verifications.
• Performs filtration setup, product filtration, pre-filtration sampling, and post-filtration sampling of products.
• Performs cleaning, disinfecting and storage of all glassware/containers used in the Serum Bulk Manufacturing, Monoclonal Production, and other manufacturing production areas.
• Assists in the preparation of components, bottles and tanks for Serum Manufacturing, Monoclonal Production, and Red Cell products.
• Ensures products are transported, processed, and stored in a manner that prevents contamination.
• Follows appropriate control measures to prevent mixing of dissimilar production components in compliance with Good Manufacturing Practices.
• Performs visual inspections of product for defects, in-process serological testing and chemistry testing.
• Creates legible written forms and Manufacturing Records that comply with all procedures and Good Documentation Practices. Records completed with minimal corrections.
• Follows applicable laboratory & OSHA regulations with respect to hazards and blood-borne pathogens.
• Maintains a neat, clean, and orderly work environment.
• Independently performs equipment setup, operation, re-supply, documentation, cleaning, minor adjustments and minor maintenance tasks to meet standards for safety, quality, reliability, and efficiency.
• Performs routine room maintenance including cleaning/disinfecting of assigned room/area and disposal of contaminated waste.
• Applies FDA regulations, and ISO standards to department operations and understands consequences of non-conformance.
• Moves, stores, and inventories production supplies and materials according to department specifications.
• Completes all training and qualification requirements; actively participates in on-going training and the training of new employees.
• Assist and communicate with co-workers to assure all safety, quality, and efficiency objectives are achieved.
• Demonstrate supportive behaviors towards co-workers and cooperate as a member of the team.
• Demonstrate behaviors supportive of personal and professional growth of self and co-workers.
• Assists in SOP revisions.
• Assists department in process improvements and validation activities.
• Performs cycle counts and maintains accurate inventory for the department.
• Performs ERP entries (Production Orders, Material Transfers, BOMs) and data entry support, as needed.
• Assists with Manufacturing Record and form review for Serum Manufacturing, Monoclonal Production and cleaning/maintenance records as needed.
• Performs other duties and responsibilities as assigned
• Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

Interacts with the following individuals:

• Other manufacturing departments at different levels
• Calibration/Maintenance
• IT department
• Document Control
• Procurement/Receiving
• Vendor

Minimum Knowledge & Experience required for the position:

Education: Bachelor’s degree (BS/BA) from four-year college or university; or equivalent combination of education and experience.

Experience: A minimum of 1 year experience preferred.

Skills & Capabilities:

• Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and government regulations. Ability to write reports, business correspondence and procedure manuals.
• Mathematical Skills: Ability to work with mathematical concepts, such as, probability and statistical interference, and fundamentals of plane and solid geometry, and trigonometry. Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.
• Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, and diagram form. Ability to deal with problems involving several concrete variables in standardized situations

Travel requirements:

Not Applicable