Job Title: Deviation Investigation Writer Job 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 candidate should have experience in a cGMP manufacturing environment. Responsibilities + Write deviations within target timelines. + Conduct root cause investigations and write reports within target timelines. + Define corrective and preventive actions (CAPA) to prevent event recurrence. + Write effectiveness check acceptance criteria for investigations. + Conduct risk assessments. + Support CAPA implementation activities by owning change controls, revising documents, or revising batch records. + Conduct investigations for root cause analysis, out of specification, and environmental monitoring. + Engage with supervisors and operators in the area of investigations. + Conduct technical writing, assemble groups for reviewing preliminary findings, and write CAPAs and corrective actions. + Implement CAPAs and evaluate the time burden for realistic goals. + Utilize Smart Sheets for project management and Power V1 for query programs. + Conduct internal follow-up from client or regulatory audits. Essential Skills + Technical writing expertise. + Experience with FDA regulations. + Proficiency in cGMP standards. + Root cause analysis and investigations. + Experience with CAPA and corrective actions. + Risk assessment capabilities. + Regulatory affairs knowledge. + Fishbone methodology proficiency. Additional Skills & Qualifications + College degree required. + Exceptional attention to detail. + Highly organized and able to manage dynamic priorities. + Experience in writing root cause analysis investigations using industry tools. + Strong technical writing skills. + Current Good Manufacturing Practices (cGMP) experience required. + Good Documentation Practices (cGDP) experience required. + Cleanroom experience and experience wearing Personal Protective Equipment (PPE) preferred. + Experience with electron beam terminal sterilization preferred. + Excellent verbal and written communication skills. + Proficiency with Microsoft Office Suite (Word, Excel) and various software programs. + Strong work ethic and teamwork abilities. + Reliable transportation and punctuality are required. + Soft skills: detailed, organized, communicative, proactive, open-minded, ability to build relationships and trust, lead with empathy, and conduct effective investigations. 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 27, 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.