Description

This position is primarily responsible for supporting the Quality department as a deviation and/or investigation writer. The ideal candidate will have experience conducting root cause analysis investigations, determining appropriate corrective and preventive actions and defining effective check criteria. Additionally, the ideal candidate will have experience in a cGMP manufacturing environment.

Responsibilities

Writing deviations within target timelinesWriting root cause investigations with target timelinesDefining corrective and preventive actions (CAPA) to prevent event recurrenceWriting effectiveness check acceptance criteriaWriting risk assessmentsMay support CAPA implementation activities through owning change controls, revising documents, or revising batch recordsWriting effectiveness check acceptance criteria for investigations

Additional Skills & Qualifications

College degree requiredExceptional attention to detailHighly organized, with demonstrated ability to manage dynamic prioritiesExperience writing root cause analysis investigation using industry toolsStrong technical writing skillsCurrent Good Manufacturing Practices (cGMP) experience requiredGood Documentation Practices (cGDP) experience requiredCleanroom experience & experience wearing Personal Protective Equipment (PPE) preferredExperience with electron beam terminal sterilization preferredExcellent verbal and written communication skillsExperience with Microsoft Office Suite (Word, Excel) and ability to utilize various software programsStrong work ethic and ability to work effectively as a teamReliable transportation and punctuality are required

Pay and Benefits

The pay range for this position is $33.65 - $43.27/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 Lakewood,CO.

Application Deadline

This position is anticipated to close on Aug 13, 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.