Sr. Manufacturing Associate
Sunrise Systems, Inc., SUMMIT new jersey
Sunrise System Inc. is currently looking for Sr. Manufacturing Associate - Liso Cell - CAR-T in Summit, NJ with one of our top client.
Job Title: Sr. Manufacturing Associate - Liso Cell - CAR-T
Location: Summit, NJ 07901
Duration: 6+ months possible to hire
Position Type: Hourly contract Position (W2 only)
Day shift structures are Quad 1 or Quad 3, 5 am-5:30 pm, Sunday through Wednesday or Wednesday through Saturday.
Night shift structures are Quad 2 or Quad 4, 5 pm to 5:30 am, Sunday through Wednesday or Wednesday through Saturday. Start and end times are subject to change based on business demands.
Start Date: 3/2. Possibility of offers with no interviews.
1. Purpose and Scope of Position:
· 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.
2. Required Competencies: Knowledge/ Skills, and Abilities:
· Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
· Knowledge of cGMP/FDA regulated industry
· Familiarity with Lean Manufacturing initiatives
· 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
3. Duties and Responsibilities:
· Oversee set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
· Performs 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.
4. Education and Experience:
· Bachelor’s degree or Associate/ Medical Technical degree and 4 years of Manufacturing or Operations experience or High School diploma/GED and 6 years of Manufacturing or Operations experience.
5. 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.
· Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.
Chenchukala Alwar | Recruiter
Direct: (732) 313 0243| Email: [email protected]
Satya | Delivery Manager
Direct: (732) 272 0262 |Email: [email protected]