Description

• Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department.

• Schedules and monitors daily operation of department based on projected client demands.

• Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.

• Approval of investigations and documentation of non-confirming events and OOS.

• Recommends process improvements to achieve greater efficiency within the department and between sites.

• Participates in department and cross functional meetings.

• Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.

• Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.

• Manages projects and leads initiatives in the workplace. Organizes resources, people, and activities; and ensures collaboration and the achievement of project and function goals and targets. Ensures effectiveness and efficiency in the delivery of services, products and/or programs.

Skills Needed

Flow cytometry, cell culture, ELISA assays, PCR/qPCR, cell counting & aseptic technique (ISO-7) Document control, quantitative analysis, & investigations cGMP experience is a must

Additional Skills & Qualifications

• Bachelor’s degree in Science or relevant field; Minimum of 7+ years of experience with analytical laboratory or within the biopharmaceutical industry or equivalent.

• Strong knowledge of FDA and EU regulatory standards. cGMP experience required.

Strong knowledge of analytical test methods and philosophies.

• Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.

• Proficient with computer software with MS Office and LIMS.

• QC Analysts (Approximately 8-10 reports)

Pay and Benefits

The pay range for this position is $42.00 - $51.59

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 Allendale,NJ.

Application Deadline

This position will be accepting applications until Jan 7, 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.