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:
|
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:
Responsible for cryopreservation and management of including:
• Handling patient material throughout the material Cryopreservation, 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.
• Maintaining metrics for the Value Stream Cryo Operations group.
• Facilitating cold chain transfers of material, as required.
• Performs tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP’s) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
The job requires handling cryo-stored patient materials in and out of storage tanks. Carrying between 10 to 30lbs of cryo-storage materials.
Please let me know what her response is EOD.
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.
Below is the brief introduction of SPECTRAFORCE, the benefits we offer and the disclaimers:
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. Our entire workflow and teams are trained to cultivate the joy of NEWJOBPHORIA® with candidates and employees throughout their engagement with SPECTRAFORCE. http://www.spectraforce.com
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 nahr@spectraforce.com if you require reasonable accommodation.