Job Details
Position: Manufacturing Associate
Duration: 06 Months
Location: Summit West, NJ, 07901
Pay range: $24 to $25.16/hr
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.