What are the responsibilities and job description for the ASSOCIATE SCIENTIST – QC SAMPLE MANAGEMENT position at Actalent?
Description
Schedule - Monday-Friday Standard Business Hours
100 Onsite Position!
The Assistant Scientist Clinical QC Sample Management position is responsible for the movement and control of Quality Control QC samples and materials in support of the QC laboratories at the CAR T manufacturing facility in Warren NJ. This primarily includes but is not limited to sample collection and distribution inventory control chain of custody sample tracking documentation and shipments within the cGMP operation for CTDO Developmental QC for CAR T.
Required Competencies: Knowledge Skills and Abilities
- Experience with cold chain sample storage and transfer.
- Experience working in a GMP regulated environment.
- Strong communication skills oral and written. Proficient with computer software programs/ applications and capable of preparing technical reports as required.
- Ability to follow and apply global regulatory and GMP requirements.
- Ability to follow create revise and review SOPs.
- Ability to work in a collaborative team environment.
- Ability to work independently for extended periods of time with minimal supervision.
- Ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
Duties and Responsibilities
- Ensures the chain of custody of QC samples are maintained throughout the complete life span of samples: receipt handling storage distribution transfer and destruction of QC samples at the site.
- 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.
- Responsible for sampling clinical QC incoming materials in collaboration with warehouse personnel and CAR T QC incoming material team.
- Initiating and performing investigations Deviations/CAPAs/Change Controls related to sample management.
- Prepares and presents continuous improvement projects to management.
- Performs document review related to sample management.
- Create and revise SOP FORM WP and TRN related to sample management.
- Provide range of support of QC services such as ordering and receipt of lab supplies.
- Establish and maintain inventory of QC incoming material QC material retain QC samples and QC regulatory retains.
- Coordinate and lead trainings for sample management.
- Develop understanding and assembly of weekly process schedule assignment for drug product samples and incoming QC materials.
- Assist in analytical sample trouble shooting and investigations as needed.
- Demonstrate general understanding of root cause analysis and CAPA methodologies.
- Maintaining metrics for the sample management group.
- Facilitating cold chain transfers of samples as required.
- Assist with preparation and execution of equipment installations related to sample management.
- Perform other tasks as assigned.
Education and Experience
- Bachelors degree required preferably in chemistry microbiology or related science.
- 2-3 years of relevant work experience preferably in a GMP regulated environment.
- An equivalent combination of education and experience may substitute.
- Sample management experience is a PLUS.
Pay and Benefits
The pay range for this position is $30.00 - $30.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Warren,NJ.
Application Deadline
This position is anticipated to close on Feb 14, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $30
