Quality Assurance Specialist I
Actalent
Job Title: Quality Assurance Specialist IJob Description
The Histology Quality Assurance Specialist I is responsible for proficiently performing routine histology techniques, solution preparation, supply management, maintenance, and operation of laboratory equipment and workstations. The role also includes good documentation practices (GDP) in recordkeeping to support Quality Control Product Release Testing. This includes all aspects of routine histology such as sample receipt and accessioning, initial sample preparation (e.g., rehydration, rinsing, generating labels, etc.), standard grossing and observations, fixation, paraffin and cryo-embedding, paraffin and cryo-microtomy, and Hematoxylin & Eosin (H&E) staining. Depending on skillset and training, the Specialist may also perform some histochemical stains (Special Stains) such as Verhoeff-Van Gieson (VVG) for product release testing, as well as routine histology testing of donor biopsies, explants, fresh, in-process, or final product samples for Tissue Services, Complaints, and Research & Development (R&D). Compliance with standard operating procedures (SOPs), laboratory safety procedures, and maintenance of department databases/files are required. Additionally, the Specialist is responsible for troubleshooting histology techniques and equipment issues, supporting equipment validations, cross-functional training activities, continuous/process improvement projects, and the Quality Management System.
Responsibilities
+ Perform routine histology techniques
+ Prepare solutions and manage supplies
+ Maintain and operate laboratory equipment and workstations
+ Follow good documentation practices (GDP) in recordkeeping
+ Handle sample receipt and accessioning
+ Prepare samples (rehydration, rinsing, generating labels, etc.)
+ Conduct standard grossing and observations
+ Perform fixation, paraffin and cryo-embedding, paraffin and cryo-microtomy, and H&E staining
+ Perform histochemical stains (Special Stains) for product release testing as needed
+ Conduct routine histology testing of donor biopsies, explants, fresh, in-process, or final product samples
+ Comply with standard operating procedures (SOPs) and laboratory safety procedures
+ Maintain department databases/files
+ Troubleshoot histology techniques and equipment issues
+ Support equipment validations
+ Participate in cross-functional training activities
+ Engage in continuous/process improvement projects
+ Support the Quality Management System
Essential Skills
+ Bachelor’s degree in biology, related science, or equivalent
+ Completion of an accredited histotechnology program
+ ASCP Histotechnician (HT) or Histotechnologist (HTL) certification
+ Previous laboratory experience in histology, pathology, or molecular/cell biology
+ Developed skills in protocol development and troubleshooting
+ Familiarity with clinical settings and regulations
Additional Skills & Qualifications
+ A.S. in Biology/related science or equivalent work experience
+ Technical Certification (HT, HTL, QIHC, or related) preferred/eligible
+ 5+ years of histology technique experience
+ 3-5 years of laboratory experience in a GXP environment
+ 1-3 years of experience in histochemistry (Special Stains)
Work Environment
You will be working in a cGMPs, GDP, ISO, FDA regulated USP environment. The shifts are from Monday to Friday, with flexible hours: one shift from 7:30 AM to 4:00 PM and another from 10:30 AM to 7:00 PM.
Pay and Benefits
The pay range for this position is $30.00 - $30.00
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 Branchburg,NJ.
Application Deadline
This position will be accepting applications until Jan 10, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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