Quality Documentation Specialist

Job Title: Quality Documentation Specialist Job Description As a Quality Documentation Specialist, you will be responsible for authoring administrative changes to department documents and facilitating the end-to-end management of these documents. This includes conducting training requirements impact assessments, reviewing document content to ensure adherence to defined processes, and managing the document lifecycle in compliance with applicable procedures and regulatory requirements. Responsibilities + Author administrative changes to department documents. + Facilitate end-to-end management of documents, including impact assessment and training requirements. + Manage controlled documentation throughout its lifecycle and ensure compliance with procedures and regulatory requirements. + Collaborate with Business Owners to manage document changes and meet timelines. + Deliver quality customer service and domain knowledge to stakeholders. + Review documents to ensure changes are documented and justified according to procedural requirements. + Identify and implement continuous improvements to enhance the efficiency of document control and training processes. + Train users on document management and training processes, as required. + Collect and provide data on key performance indicators, as required. + Support additional assignments and projects, as required. Essential Skills + Minimum of 2 years of experience in the biotech or pharmaceutical industry. + Minimum of 2 years of experience with Electronic Document Management Systems (EDMS). + Experience with document control and performing technical aspects of the role. + Proficient in Microsoft Word and Excel. + Knowledge of Good Manufacturing Practices (GMPs) and document control fundamentals. + Understanding of pharmaceutical industry regulations including 21 CFR, GxP, ICH, etc. + Strong verbal, written, and interpersonal communication skills. Additional Skills & Qualifications + Experience with Veeva Vault or willingness to train on this system. Work Environment You will work from home on Mondays and Fridays, with required on-site presence on Tuesday, Wednesday, and Thursday. The position involves working in a high-speed environment, managing a high volume of documents, with expectations of processing six documents daily and handling up to 100 documents per month. Job Type & Location This is a Contract position based out of Foster City, California. Pay and Benefits The pay range for this position is $32.00 - $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: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Foster City,CA. Application Deadline This position is anticipated to close on Oct 28, 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 ( ) for other accommodation options.

Created: 2025-10-16