Job Title: Quality Control Analyst

Job Description

The successful candidate will be responsible for performing routine quality control testing utilizing various biological and general laboratory techniques according to cGMP regulations. The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of laboratory instrumentation. In addition, effective communication skills with minimal supervision are essential for success.

Responsibilities

• Carry out product testing and stability studies, as needed.
• Perform troubleshooting and preventive maintenance of laboratory equipment.
• Write documents for regulatory submissions such as standard test methods, validation reports, and SOPs.
• Provide technical assistance and training to other laboratory personnel.
• Understand and comply with all company policies, safety procedures, and SOPs, including cGMPs and cGLPs.
• Prepare analytical data for internal and external meetings and presentations.
• Conduct laboratory tests in compliance with established Standard Test Methods, compendial methods, and vendor/partner methods.
• Maintain organized records of tests performed and results obtained following company policies.
• Assist in performing laboratory investigations and write investigation reports as required.
• Maintain a level of technical knowledge and understanding in the assigned areas of responsibility that are consistent with the current scientific requirements of the company.
• Lead in the transfer of methods to/from the Quality Control department.
• Represent functional area in Project Teams, as required.
• Test and release finished products for US Commercial and Clinical use.
• Test and release finished products for EU Commercial and Clinical use prior to final QP Certification of batches for EU distribution.

Essential Skills

• Environmental monitoring
• Microbiology
• Quality Control
• Aseptic Techniques
• Pipetting skills
• Laboratory knowledge
• Quality assurance
• Audit

Additional Skills & Qualifications

• BS degree in biological sciences or related field
• 3-5 years relevant laboratory experience in a cGMP/FDA regulated industry within biotech, pharma, or med device
• Experience with cell culture, sterile techniques, bench chemistry, and cleanroom operations

Work Environment

The candidate will work in both a lab and office setting. The lab is a cleanroom environment with level 10k and 100k cleanroom standards. The position requires sterile gowning and maintaining certification for sterile gowning. Work hours are from 6:00 AM - 4:00 PM or 8:00 AM - 6:00 PM, with shifts from Sunday to Wednesday or Wednesday to Saturday.

Pay and Benefits

The pay range for this position is $72000.00 - $81000.00

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 WINSTON SALEM,NC.

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.

Salary : $72,000 - $81,000