Quality Documentation Specialist

Quality Documentation Specialist

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:

• 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 hybrid position in Foster City,CA.

Application Deadline

This position is anticipated to close on Oct 28, 2025.