Branchburg, New Jersey, USA
3 days ago
Quality Assurance Specialist I
Job Title: Quality Assurance Specialist I
Job 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.

ResponsibilitiesPerform routine histology techniquesPrepare solutions and manage suppliesMaintain and operate laboratory equipment and workstationsFollow good documentation practices (GDP) in recordkeepingHandle sample receipt and accessioningPrepare samples (rehydration, rinsing, generating labels, etc.)Conduct standard grossing and observationsPerform fixation, paraffin and cryo-embedding, paraffin and cryo-microtomy, and H&E stainingPerform histochemical stains (Special Stains) for product release testing as neededConduct routine histology testing of donor biopsies, explants, fresh, in-process, or final product samplesComply with standard operating procedures (SOPs) and laboratory safety proceduresMaintain department databases/filesTroubleshoot histology techniques and equipment issuesSupport equipment validationsParticipate in cross-functional training activitiesEngage in continuous/process improvement projectsSupport the Quality Management SystemEssential SkillsBachelor’s degree in biology, related science, or equivalentCompletion of an accredited histotechnology programASCP Histotechnician (HT) or Histotechnologist (HTL) certificationPrevious laboratory experience in histology, pathology, or molecular/cell biologyDeveloped skills in protocol development and troubleshootingFamiliarity with clinical settings and regulationsAdditional Skills & QualificationsA.S. in Biology/related science or equivalent work experienceTechnical Certification (HT, HTL, QIHC, or related) preferred/eligible5+ years of histology technique experience3-5 years of laboratory experience in a GXP environment1-3 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 for other accommodation options.

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