Description

•\tPerform duties related to and maintain the GxP document control system consisting of product related documentation, quality manual, external documentation, department procedures and work instructions.

•\tInitiate and/or coordinate all incoming, in-process and completed document change control, associated supporting documentation and following up to ensure the changes are completed and documentation is properly closed out and released.

•\tPerform duties relate to and maintain GxP training program including the training assignments, archival of completed records, oversight of training compliance, and periodic auditing of training records.

•\tTrain new users in using the document control and training systems, as needed.

•\tProvide guidance on document control practices and procedures to all functional departments.

•\tSupport the maintenance and improvement of quality systems processes, as needed.

•\tEnforce compliance with processes/procedures, policies and GxP standards.

•\tRun reports for all aspects of the document control & training processes including training reports and generating metrics for QA and sub-functional teams, as needed.

•\tWorks with internal stakeholders with assistance from QA leadership to ensure follow-up and closure of quality issues.

•\tOther tasks assigned by the management.

Additional Skills & Qualifications

Required Skills, Experience and Education:

•\t5+ years of relevant experience in bio-pharmaceutical environment Quality Systems

•\tExperience with Veeva QualiySuite Platforms (Veeva QualityDocs, VaultTraining, Veeva QMS)

•\tBachelor of Science in Life Sciences, Engineering, or related discipline

Preferred Skills:

•\tAbility to work in a team environment, manage multi-tasking, and discipline in completing tasks on schedule.

•\tExcellent written and verbal communication skills.

•\tProficient in Microsoft Office skills (WORD, Excel, PowerPoint).

Pay and Benefits

The pay range for this position is $45.00 - $55.00/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 Redwood City,CA.

Application Deadline

This position is anticipated to close on Feb 19, 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 for other accommodation options.