QA Specialist

QA Specialist

Job Description

We are seeking a dedicated QA Specialist to join our team in the Quality Notifications department. This role is essential in ensuring product quality and compliance with regulatory standards. The successful candidate will be responsible for driving internal investigations and implementing corrective actions to enhance customer satisfaction.

Responsibilities

Drive internal investigations, including product evaluation and process review, to determine the root cause of quality issues.

Collaborate with cross-functional teams to successfully implement corrective actions.

Implement and maintain procedures in strict compliance with 21 CFR Part 820 Quality System Regulations, ISO standards, and other applicable international standards.

Monitor and document various metrics, including complaint / product handling, stability testing, and performance, and present them to the Quality Review Board and other relevant parties.

Test products for microbial performance using ATCC organisms, providing timely and accurate responses to customer inquiries.

Prepare written responses to quality notifications or inquiries from customers, demonstrating exceptional written communication skills.

Lead issue review investigations to address concerns raised by customer complaints, ensuring that all issues are thoroughly addressed and resolved.

Review quality documentation, such as device history records and processing records, to ensure compliance with internal policies and process requirements.

Serve as an expert for complaint / product issues, providing guidance and support to colleagues across the organization.

Collaborate with customers and technical service representatives to effectively address and resolve any customer issues.

Participate in the development, maintenance, and monitoring of programs for compliance with the Quality Systems Regulations (QSR) and internal procedures.

Essential Skills

Bachelor's Degree in a science or related field with some laboratory experience.

1 year of experience in a regulated environment such as medical device, pharmaceutical, biotechnology, or clinical.

2 semesters or 1 year of experience in a laboratory setting using various software programs such as Excel and PowerPoint.

Additional Skills & Qualifications

Bachelor of Science Degree in Biology or Microbiology.

2+ years of experience in a regulated environment such as medical device, pharmaceutical, biotechnology, or clinical.

Strong understanding of quality-related tools, such as structured problem solving, data trending, and FMEA (Failure Mode and Effects Analysis).

Experience in Quality Control Microbiology.

Work Environment

This position requires onsite work from Monday to Friday, 8am to 4 : 30pm. The role involves collaboration with cross-functional teams and requires adherence to strict quality and regulatory standards.

Job Type & Location

This is a Contract position based out of Lenexa, KS.

Pay and Benefits

The pay range for this position is $30.00 - $30.00 / 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 Lenexa,KS.

Application Deadline

This position is anticipated to close on Nov 24, 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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.