Job Title: Quality Assurance, Document Control Specialist

Job Description

We are seeking a dedicated Quality Assurance, Document Control Specialist to manage and maintain controlled documents within our Electronic Document Management System (EDMS). The ideal candidate will work independently to review Standard Operating Procedures (SOPs) and form content, exercising sound judgment to provide recommendations for alignment with best practices. This role involves assisting in the development and validation of electronic Quality Management Systems (QMS), tracking document reviews and approvals, and coordinating the review, finalization, and archival of client policies and procedures.

Responsibilities

• Independently document and maintain controlled documents in the EDMS with minimal assistance.
• Review SOP and form content to provide alignment suggestions with client controlled document procedures.
• Assist in the development, administration, and validation of electronic QMS.
• Track controlled documents to ensure timely reviews and approvals within the EDMS.
• Coordinate the review, finalization, and archival of client policies and procedures.
• Edit and proofread controlled documents for consistency and adherence to Quality Systems processes.
• Follow GxPs and client SOPs utilizing advanced MS Office features.
• Lead the implementation of document control process improvements.
• Undertake other responsibilities as established by the GMP Quality Lead.

Essential Skills

• Bachelor's degree in biological sciences, physical sciences, or equivalent experience.
• 2-5 years of experience in documentation within a regulated industry.
• Advanced MS Office skills (Outlook, Word, Excel, PowerPoint).
• Knowledge of GxP requirements and guidelines.
• Experience with document control activities.
• Proficiency in maintaining a document and data control system.

Additional Skills & Qualifications

• Experience with advanced Document Control systems preferred.
• Strong written, oral, and interpersonal communication skills.
• Demonstrated ability to adapt to changes, delays, or unexpected events.
• Understanding of FDA regulatory requirements related to documentation.
• Extensive MS Word processing and formatting experience required.
• Experience in automating processes using MS Office products.
• Attention to detail and ability to perform detail-oriented work accurately.
• Ability to effectively communicate and share knowledge with a team.
• Learning Management System experience is a plus.

Work Environment

This position will involve interaction with all internal employees, contractors, and consultants utilizing the EDMS.

Pay and Benefits

The pay range for this position is $22.00 - $28.00/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 Philadelphia,PA.

Application Deadline

This position is anticipated to close on May 20, 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 actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $22 - $28