Training schedule: 4-6 weeks, ONSITE training (9 - 5, Mon - Fri)
Description:
Manufactures human blood-derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.
Required Competencies: Knowledge/ Skills, and Abilities:
Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
Knowledge of
Basic mathematical skills
General understanding of cGMPs
Technical writing capability
Proficient in MS Office applications
Background to include an understanding of biology, chemistry, medical or clinical practices
Duties and Responsibilities:
Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
Support deviation investigations and write ups as needed.Support on time closure of any assigned CAPAs within the designated shift.
Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum. Aseptic qualification is required.
Weighs and measures in-process materials to ensure proper quantities are added/removed.
Adheres to the production schedule ensuring on-time, internal production logistics.
Records production data and information in a clear, concise, format according to proper GDPs.
Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
Motivated, team consciousness individuals are needed to fulfill job requirements.
Become a SME and qualified trainer within a designated function of manufacturing.Supervision will be managed by the shift Supervisor or designated Team Lead.
Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge.
Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc.
Education and Experience:
Bachelor's degree
or Associate/ Medical Technical degree and 3 years of Manufacturing or Operations experience
or High School diploma/GED and 2 years of Manufacturing or Operations experience.
Important Notes about working in the clean room:
Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
Ability to wear cleanroom garments and personal protective equipment (gloves, frocks, and hoods) required in designated areas which cover the head, parts of the face, core body, hands and legs/feet.
Work in a manner to maintain cleanroom behaviors
Jewelry, makeup, hair products, nail polish, nail extensions or other potential microbial sources are prohibited in cleanroom work areas.
Working Conditions:
Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
Must be comfortable working with contained human blood components.
Physical dexterity sufficient to use computers and documentation.
Sufficient vision and hearing capability to work in job environment.
Ability to lift 25 pounds.
Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
Flexibility to don clean room garments and personal protective equipment (PPE).
Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
Routine exposure to human blood components.Exposure to strong magnets is likely.
Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.