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Assistant Specialist, QC Sample Management

Spectraforce

Summit, New Jersey


3 months ago

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Assistant Specialist, QC Sample Management
Spectraforce
Summit, New Jersey

3 months ago

Job Description

Position Title:   Assistant Specialist, QC Sample Management
Direct Manager:  Supervisor, Sample Management
Division:    CTDO Quality Control
Duration: 06 Months
Location:    Summit West, S-12, 07901


Shifts: 

(Wed-Sat 6am-430pm)


PURPOSE AND SCOPE OF POSITION:
The Assistant Specialist, Sample Management, is responsible for the movement and control of QC samples and materials in support of the QC laboratories at the CAR T manufacturing facility in Summit, NJ.  This includes, but is not limited to, management of liquid nitrogen tank inventory, sample collection and distribution, inventory control, chain of custody, sample tracking, and sample delivery.

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities:
•    Experience with cold chain sample storage and transfer.
•    Experience working in a GMP regulated environment.
•    Ability to work in a classified cleanroom environment and follow all applicable gowning requirements and procedures.
•    Ability to follow and apply global regulatory and GMP requirements.
•    Ability to follow SOPs.
•    Ability to work in a collaborative team environment.
•    Ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.

Education and Experience:    •    2+ years of relevant work experience, preferably in a regulated/cGMP environment.
•    An equivalent combination of education and experience may substitute.

DUTIES AND RESPONSIBILITIES:
Contributes to the management of test samples and reagents, including:
•    Handling test samples throughout the sample lifecycle- receipt, storage, distribution, transfer, and disposal.
•    Maintaining sample tracking and chain of custody records in accordance with GMP requirements and written procedures.
•    Ensuring that obsolete or expired samples and materials are destroyed and disposed of according to written procedures.
•    Performing sample queries and periodic storage reports, as required.
•    Assisting management with investigations and deviations related to sample management.
•    Collaborating with other departments to identity and implement process efficiencies.
Contributes to the management of laboratory inventory, including:
•    Maintaining the inventory of laboratory supplies including reagents, media, consumables, etc.
•    Maintaining the reference standard inventory and distributing reference standards to functional groups upon request.
•    Ensuring that materials are appropriately labelled and traceable according to GMPs, regulatory requirements, and written procedures.
•    Assisting management with investigations and deviations related to laboratory inventory.
•    Maintaining 5S and FIFO principles, as appropriate.
Provides QC materials support, including:
•    Maintaining metrics for the sample management group.
•    Facilitating cold chain transfers of samples, as required.
•    Collaborating with supply chain, warehouse, and lab services to ensure all QC laboratory supplies are adequately stocked.
Performs other tasks as assigned.

WORKING CONDITIONS (US Only):
•    The incumbent should be able to distinguish colors and possess correctable vision to 20/20.
•    The incumbent will be doing light to moderate lifting, carrying, or moving objects under
15-20 lbs.
•    The incumbent will be working in a laboratory setting up to eight hours per day.
•    The incumbent will be working around biohazardous materials, including chemical agents, up to eight hours per day
•    The incumbent may be exposed to fluctuating and/or extreme temperatures on occasion.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

 

About Us: Established in 2004, SPECTRAFORCE® 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 140 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. SPECTRAFORCE 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. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides 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 LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $27.97/hr.