Job Title: Quality Assurance Specialist

Job Description

The Quality Assurance Specialist plays a crucial role in developing, managing, and maintaining documentation and training programs to ensure accuracy, accessibility, and regulatory compliance. This position supports adherence to internal quality standards and external regulations by overseeing controlled documentation, coordinating training initiatives, and monitoring key quality performance indicators.

ResponsibilitiesSupport the deployment and ongoing management of MasterControl systems, including eDMS, eQMS, and eLMS.Oversee document control processes to ensure timely review, approval, issuance, revision, and archival of controlled documents such as SOPs, batch records, and protocols.Deliver training sessions on document control practices, eDMS usage, and related procedures to staff.Enforce document control policies, including access control for authorized personnel.Ensure adherence to regulatory and internal standards, including FDA GMP and ICH guidelines.Collaborate with cross-functional teams to facilitate system adoption and user onboarding.Design, implement, and manage site-wide training programs in compliance with regulatory and corporate requirements.Monitor, track, and report on training completion rates and compliance metrics.Coordinate onboarding training for new employees and continuous training for existing staff.Provide documentation and training records to support internal and external audits.Essential SkillsBachelor’s degree in Life Sciences, Quality, or a related field.3–5 years of experience in document control and/or training within a regulated pharmaceutical, biotechnology, or food industry environment.Practical experience with electronic systems such as MasterControl or comparable platforms for eDMS, eQMS, and eLMS.In-depth knowledge of FDA regulations and current Good Manufacturing Practices (cGMP).Work Environment

The work environment involves prolonged periods of standing and walking through the manufacturing suite, as well as sitting at a desk working on computers. The role requires the ability to lift up to 15 pounds and occasionally climb stairs. The position includes direct interaction with the Quality Systems Manager and various departments, emphasizing the importance of good communication skills. The lab space is clean and organized, and the company is well-established in the area with a stable market and management, experiencing rapid growth.

Pay and Benefits

The pay range for this position is $28.00 - $34.00/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 Omaha,NE.

Application Deadline

This position is anticipated to close on Jul 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.

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 for other accommodation options.