Position: Manufacturing Associate
Duration: 06 Months – Temp to Perm
Location: Summit West, NJ, 07901
Available: Multiple Shift timings
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. 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.
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.
· This is not necessarily an all-inclusive list of job-related responsibilities, duties, skills, efforts, requirements or working conditions. While this is intended to be an accurate reflection of the current job, SPECTRAFORCE and the assigned client reserve the right to revise the job or to require that other or different tasks be performed as assigned.
· Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law.
· Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at email@example.com if you require a reasonable accommodation.
· For the full list of our open positions, please check www.spectraforce.com ·