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Job Title: QC Specialist

Job Description

The QC Specialist is responsible for performing method qualification and participating in bioanalytical assay transfer to ensure the successful start-up of the QC laboratory. The role involves executing bioanalytical and analytical methods using cell culture techniques, flow cytometry, qPCR, ELISA, and cell viability assays. The specialist will perform routine instrument maintenance, data entry, and result report generation in the LIMS system, ensuring quality and regulatory compliance.

Responsibilities

+ Perform method qualification and participate in bioanalytical assay transfer.

+ Execute bioanalytical and analytical methods using cell culture techniques, flow cytometry, qPCR, ELISA, and cell viability assays.

+ Perform routine instrument maintenance and generate data entry and result reports in the LIMS system.

+ Monitor instruments for preventative maintenance and calibration, ensuring conformance to specifications.

+ Ensure that IQ/OQ/PQ of newly purchased instruments are performed by the vendor in a timely manner.

+ Troubleshoot instruments in the lab and perform thorough investigations for any lab event/OOS/OOT/OOE results under minimal supervision in Trackwise system.

+ Perform routine QC responsibilities such as sample aliquoting, lab equipment maintenance, QC document management, QC inventory control, and reconciliation of sample requests/documents.

+ Generate and revise general procedures, protocols, and technical reports.

+ Author test methods and specifications as needed.

+ Initiate and complete QA-Track records as required.

+ Oversee laboratory equipment to maintain optimal temperature and humidity levels, ensuring consistent gas supplies for cell culture facilities.

Essential Skills

+ Proficiency in flow cytometry and quality control.

+ Experience in laboratory method validation, qualification, and transfer activities.

+ Ability to perform qualification of compendia methods related to cell-based test assays and flow cytometry.

+ Competence in routine analysis of cell culture media, reagents, and quality of cultured cells in-process.

+ Handling of flow cytometry equipment and drug substance PCR identification.

+ Ability to work independently and assist staff when necessary.

Additional Skills & Qualifications

+ Strong verbal and written communication skills with the ability to communicate complex ideas and concepts.

+ Attention to detail, particularly in reviewing documentation for SOP format adherence and accurate data entry.

+ Punctuality and flexibility in work schedule.

+ Ability to negotiate and influence key partners and suppliers effectively.

+ Bachelor's or Master's degree in Biology, Cell Biology, Immunology, Health Sciences, or a related field.

+ Minimum of 2 years of experience in a GMP setting or in the biotechnology or pharmaceutical industry.

+ Working knowledge of SOPs, cell biology, flow cytometry, analytical test methods, and generally accepted laboratory practices.

+ Comfortable working in a cell culture lab area and with viral-based gene therapy drugs.

+ Experience with LIMS and Trackwise is an asset.

Work Environment

The role requires the ability to stand on feet for up to four hours at a time and lift, push, and/or pull up to 25 pounds. The candidate must meet minimal visual acuity requirements necessary for quality assessments. The work environment includes a great facility with new clean rooms, promoting work-life balance.

Pay and Benefits

The pay range for this position is $38.00 - $41.80/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 Parsippany,NJ.

Application Deadline

This position is anticipated to close on May 16, 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.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.