Job Description

Job Title: Technical Writer (CAPA Investigations) Job Description The candidate will be helping the team by predominantly with non-conformance and deviation report writing and working on investigations within a contained facility lab. They will also be transcribing and editing various documents within the SAP program and assisting with investigations. The role involves collaborating with other departments such as production, maintenance, lab, and engineering to support their investigations and deviations. Responsibilities + Writing detailed descriptions from team inputs + Helping heavily with CAPA deviation report writing + Assisting with corrective action investigations + Making notes on processes + Obtaining information from the team and writing manuals and other sources + Writing descriptions of processes and materials + Helping with document redlining + Utilizing experience in documenting in the SAP System Essential Skills + Technical writing + CAPA + Investigative and reporting skills + Medical writing + Engineering + Work instruction + Non-conformances + CAPA Investigations Additional Skills & Qualifications + Bachelor's degree in a scientific field + 3-5 years of experience in a regulated industry + 1.5+ years of experience with investigations and technical writing + Experience writing deviation reports + Experience with CAPA is a plus + FDA experience + Pharmaceutical or medical device experience preferred Work Environment The candidate will work within a cubicle and will be interdependent, requiring interaction with other departments. Candidate must be comfortable with gowning up to enter the cleanroom and handle samples for report writing. Pay and Benefits The pay range for this position is $40.00 - $40.00/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 Irvine,CA. Application Deadline This position is anticipated to close on May 2, 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. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people 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 process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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Temporary work,

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