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Job Title: Document Control Specialist

Job Description

Join our team as a Document Control Specialist where you will play a crucial role in managing and overseeing the document control processes within our organization. Your primary tasks will include handling incoming records, managing document archives, and ensuring compliance with our quality systems.

Responsibilities

+ Document incoming records and logbooks in the record location database.

+ Prepare records for repository storage and file them in assigned locations.

+ Monitor and respond to record request inbox, managing withdrawal requests and distribution notifications.

+ Perform record management and archival tasks, including preparing and inventorying documents for internal and offsite archival.

+ Train personnel on document authoring and reviewer/approver roles within the Document Management System (DMS).

+ Perform administrator duties in DMS, including creating, revising, and managing document templates and quality documents.

+ Review documents in DMS for GDP compliance and template adherence.

+ Manage the publishing process of documents in DMS to support business initiatives.

+ Oversee archival expansion management, including training and support for various departments post-renovation.

+ Administer REAL and Veeva EDMS, including the periodic review process.

+ Ensure proper EDMS to LMS training and knowledge management content transfer.

+ Oversee Global DCC SOP, escalating inquiries as necessary and assisting with assessments.

+ Distribute project-related documents to internal teams and manage records returns and reconciliation post-production.

+ Publish DCC metrics on a monthly, quarterly, and annual basis.

+ Review and update technical documents for accuracy and compliance.

+ Manage DCC user training, troubleshooting, and CAPA deployment.

+ Digitize records in real-time, including scanning and PDF verification.

+ Manage internal and external archiving, ensuring proper oversight and updating the archiving tracker.

+ Execute post-renovation design layouts and manage records transfer from provisional locations.

Essential Skills

+ Strong computer competencies with attention to detail.

+ Excellent multi-level communication and organizational skills.

+ Proficient time management and quality system document version/revision administrative skills.

+ Minimum 5 years’ experience in Electronic Document Management (eDMS) Workflow Execution.

+ GxP industry Document Control Management knowledge.

+ Experience in records management, storage archival, and issuance of logbooks.

Additional Skills & Qualifications

+ Experience with REAL and/or Veeva eDMS is a plus.

+ 5 years Records Management knowledge, preferably with GxP Documents.

+ Clinical, research, or pharmaceutical experience is advantageous.

+ Technical writing experience within a scientific environment.

+ Proficiency in IT skills, including Word, Excel, Visio, and Microsoft Project.

Work Environment

Work within the Quality Assurance Department on a Monday to Friday 1st shift schedule, all on-site. Collaborate with various departments and gain exposure to FDA-approved projects, including new treatments for bladder cancer.

This position is moving extremely fast as this is an urgent need for the client. If interested, please send over your most up to date resume to ktrivigno @astoncarter.com along with your availability for a 10-minute phone call.

Pay and Benefits

The pay range for this position is $34.00 - $43.00/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 Parsippany-Troy Hills,NJ.

Application Deadline

This position is anticipated to close on Jun 4, 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 [email protected] (%[email protected]) for other accommodation options.