Quality Document Specialist

Quality Document Specialist

The Quality Document Specialist (QA Records Management Specialist) is responsible for managing physical and electronic records in a GxP-regulated environment, applying established policies and procedures to ensure compliant classification, coding, processing, storage, retrieval, preservation, and destruction of records. This role works closely with stakeholders across the organization to support information management and ensure adherence to legal, regulatory, and operational requirements as well as standard operating procedures.

Responsibilities

• Support the records management program to ensure that the maintenance, retrieval, inventory, retention, and destruction of all records align with established retention policies.
• Organize and process incoming records and requests promptly and accurately to maintain efficient information flow.
• Ensure the correct and timely input of database entries, verifying both personal work and the work of others for accuracy.
• Collaborate with internal customers to confirm the correct and timely implementation of records-related requests.
• Coordinate and perform scanning activities to ensure digital conversion projects are completed accurately and on schedule.
• Maintain accurate filing and ongoing maintenance of controlled documents and records in accordance with GxP and internal procedures.
• Maintain an organized inventory, directory, or index of all records within the validated records management system.
• Advise stakeholders on current industry best practices and professional trends in records and information management.
• Promote the organization's objective to reduce the use and creation of physical hardcopy files by supporting digital solutions.
• Conduct research and retrieve information and documents as requested by departments and project teams.
• Prioritize and accomplish multiple tasks in a fast-paced, deadline-driven, and detail-oriented work environment.
• Collaborate with departments to determine and implement special records management and retention requirements.
• Stay current on basic compliance requirements relevant to the records management function and own area of work.
• Provide instruction or assistance to junior staff in a lead capacity when needed.
• Notify leadership of compliance questions, concerns, and issues related to records and information management.
• Participate in training related to records management and issues affecting the assigned area of work.
• Audit records or assist auditors in conducting records audits to ensure adherence to policies and regulations.
• Support the maintenance and organization of the secured archival room for physical records.
• Provide additional support and assistance on tasks and projects as directed by management, including special initiatives in records and information governance.

Essential Skills

• 14 years of relevant experience in record retention, information governance, records management, data governance, knowledge management, or library work in a regulated environment, preferably pharma, biotech, or medical device.
• Experience working with hardcopy regulated or controlled documents and records in industries such as pharmaceutical, clinical trials, financial services, or other regulated sectors.
• Experience categorizing, organizing, and archiving regulated documents, including the ability to propose solutions and problem-solve when dealing with large volumes of records.
• Experience with electronic records systems and Microsoft Word, including handling electronic requests and creating tables in Word.
• Ability to analyze data and interpret information to improve the management of product records and documentation.
• Ability to apply and clearly explain moderately complex policies and procedures related to records management assignments.
• Ability to quickly acquire knowledge and competencies through experience, study, or training.
• Strong problem-solving skills with the ability to challenge assumptions, push boundaries, and explore new solutions.
• Effective communication skills, including the ability to share and synthesize information, influence decisions, and guide stakeholders.
• Ability to tailor communication style to different audiences and leverage networks to share information and guide outcomes.
• Ability to create and implement appropriate and effective solutions to records-related problems.
• Demonstrated ambition and agility to work digitally and pursue digital opportunities that support organizational goals.
• Knowledge of techniques for providing a high level of customer service when dealing with internal stakeholders.
• Ability to assist staff in records management procedures and the use of process-related software.
• Ability to establish, maintain, and foster positive and effective working relationships with colleagues and stakeholders.
• Ability to exercise discretion and maintain confidentiality of records and sensitive information.
• Strong team orientation, supporting the team by sharing resources and knowledge to execute shared responsibilities and goals.
• Ability to work effectively both as part of a team and independently with minimal supervision.
• Knowledge of legal aspects of records retention and disposal.
• High degree of attention to detail in all aspects of records handling and documentation.
• Minimum of a high school diploma or equivalent education.

Additional Skills & Qualifications

• Experience in pharma, biotech, medical device, or other highly regulated industries is highly preferred.
• Background in clinical trials, financial services, or similar regulated environments is beneficial.
• Experience gaining or seeking pharma/biotech records management exposure and career development.
• Interest in and aptitude for digital transformation in records and information management.
• Strong intrinsic motivation to explore new solutions and improve records processes.
• Ability to support knowledge sharing and collaboration across teams to enhance records governance.
• Comfort working with validated records management systems and process software.
• Library science, information science, or related experience is advantageous for organizing and indexing large collections of records.

Work Environment

This role is based fully onsite five days per week in a GxP-regulated environment focused on pharmaceutical and biotechnology records. The position involves regular interaction with physical hardcopy documents, secured archival storage areas, and validated electronic records management systems. Work is performed in a fast-paced, deadline-driven setting that demands careful attention to detail, strong organizational skills, and adherence to standard operating procedures. The environment supports digital work, including use of Microsoft Word and electronic records systems, and emphasizes collaboration with cross-functional teams to maintain compliant and efficient records management practices.

Job Type & Location

This is a Contract position based out of Foster City, CA.

Pay and Benefits

The pay range for this position is $30.00 - $40.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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 Foster City, CA.

Application Deadline

This position is anticipated to close on Sep 9, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

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