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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 timelines

+ Writing root cause investigations with target timelines

+ Defining corrective and preventive actions (CAPA) to prevent event recurrence

+ Writing effectiveness check acceptance criteria

+ Writing risk assessments

+ May support CAPA implementation activities through owning change controls, revising documents, or revising batch records

+ Writing effectiveness check acceptance criteria for investigations

Additional Skills & Qualifications

+ College degree required

+ Exceptional attention to detail

+ Highly organized, with demonstrated ability to manage dynamic priorities

+ Experience writing root cause analysis investigation using industry tools

+ Strong technical writing skills

+ Current Good Manufacturing Practices (cGMP) experience required

+ Good Documentation Practices (cGDP) experience required

+ Cleanroom experience & experience wearing Personal Protective Equipment (PPE) preferred

+ Experience with electron beam terminal sterilization preferred

+ Excellent verbal and written communication skills

+ Experience with Microsoft Office Suite (Word, Excel) and ability to utilize various software programs

+ Strong work ethic and ability to work effectively as a team

+ Reliable 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 [email protected] (%[email protected]) for other accommodation options.