Job Title: Document Control Associate

Job Description

Process, track, and manage QA documentation, including login, review, approval, distribution, and archiving. Support the revision, review, and controlled distribution of Standard Operating Procedures (SOPs) and other cGMP-related documents. Help resolve minor discrepancies by coordinating with document originators and making necessary updates. Maintain accurate and reliable filing systems for documentation, ensuring organization and easy access to records. Assist in the creation and maintenance of Certificates of Analysis (COAs) as required. Aid in managing and tracking training documentation, including the maintenance of the training matrix and training files. Participate in routine documentation audits and support internal and external audits as needed. Assist with other quality system tasks, such as document control, CAPA (Corrective and Preventive Action), and Change Control under supervision.

Responsibilities

• Process, track, and manage QA documentation, including login, review, approval, distribution, and archiving.
• Support the revision, review, and controlled distribution of Standard Operating Procedures (SOPs) and other cGMP-related documents.
• Help resolve minor discrepancies by coordinating with document originators and making necessary updates.
• Maintain accurate and reliable filing systems for documentation, ensuring organization and easy access to records.
• Assist in the creation and maintenance of Certificates of Analysis (COAs) as required.
• Aid in managing and tracking training documentation, including the maintenance of the training matrix and training files.
• Participate in routine documentation audits and support internal and external audits as needed.
• Assist with other quality system tasks, such as document control, CAPA (Corrective and Preventive Action), and Change Control under supervision.

Essential Skills

• Basic understanding of cGMP standards and documentation
• Experience reviewing and editing documentation with detail and accuracy
• Proficient in Microsoft Office (Word, Excel, PowerPoint) and Adobe
• Quality-focused mindset and willingness to learn/adapt
• Ability to multitask and handle priorities in a fast-paced environment

Additional Skills & Qualifications

• Experience with document control systems and regulatory compliance
• Basic understanding of quality systems like CAPA, Change Control, and SOP

Work Environment

This position involves working 100% with documentation. The work environment is fast-paced and requires meticulous attention to detail. The role involves using various software such as Microsoft Office and Adobe to manage and maintain documentation records. This is a highly collaborative environment where you will interact with various departments to ensure quality and compliance with industry standards.

Pay and Benefits

The pay range for this position is $21.00 - $23.00

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 Saint Paul,MN.

Application Deadline

This position will be accepting applications until Jan 22, 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.

Salary : $21 - $23