Manufacturing Technician (Production)

Summit, NJ, United States

Position: Manufacturing Associate

Duration: 06 Months

Location: Summit West, NJ, 07901

Pay range: $24 to $25.16/hr

Breyanzi activation MO QUAD SCHEDULE:

Quad 2 Sun – Tue & alternating Wed 5 pm – 5:30 am,

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.

Below is the brief introduction of SPECTRA FORCE , the benefits we offer and the disclaimers:

Established in 2004, SPECTRA FORCE is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams.

We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 130 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation.

SPECTRA FORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people (and clients) can reach their highest potential. Our entire workflow and teams are trained to cultivate the joy of NEWJOBPHORIA® with candidates and employees throughout their engagement with SPECTRA FORCE . http://www.spectraforce.com

Benefits: SPECTRA FORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRA FORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRA FORCE offers unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer : SPECTRA FORCE 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 protected] if you require reasonable accommodation.