Document Control Specialist

Job Title: Document Control SpecialistJob Description

We are seeking a Document Control Specialist to manage the receipt, organization, and distribution of records and documents for our locations. The role involves utilizing document management systems (DMS) and ensuring compliance with quality standards and regulatory requirements.

Responsibilities

• Receipt of incoming records and logbooks/notebooks.
• Document records receipt in the record location database.
• Prepare records for repository storage and file them in the assigned storage location.
• Monitor the record request inbox and respond to incoming record withdrawal requests.
• Prepare requested records for distribution and notify requestors when records are available.
• Follow up and reconcile distributed records.
• Manage records retention programs and inventory documents for internal and offsite archival.
• Train personnel for document authoring, reviewer, and approver roles within the DMS.
• Perform administrator duties in the DMS, including creating, revising, and managing document templates.
• Review documents in the DMS for GDP compliance and template adherence.
• Manage the publishing documents process in the DMS to support business initiatives.
• 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 and assist with impact gap analysis and business owner assessments.
• Distribute project/production-related copies to internal teams.
• Manage post-production records returns and reconciliation.
• Publish DCC metrics monthly, quarterly, and annually.
• Review and update technical documents for accuracy.
• Revise and assess DCC (QS) SOPs.
• Provide user training and troubleshooting for DCC systems.
• Digitize DCC records in real-time and archived files.
• Manage internal and external archiving, including oversight of physical records filing and external archival management.
• Execute post-renovation design layout for DCC locations.
• Transfer or discontinue provisional DCC locations.
• Manage increased volume of documents for new product technical transfers.
  
  

Essential Skills

• Strong computer competencies.
• Attention to detail.
• Multi-level communication skills.
• Organizational skills.
• Time management skills.
• Quality System (QS) document version/revision administrative skills.
• Exceptional accuracy.
• Minimum 5 years of Electronic Document Management (eDMS) workflow execution experience (e.g., REAL, Veeva, Documentum, Qualio, Pilgrim, Master Control, QT9, Qualityze, ContractWorks).
• GxP industry document control management knowledge and skills.
  
  

Additional Skills & Qualifications

• REAL and/or Veeva eDMS experience is a plus.
• 5 years of records management knowledge/experience, preferably with GxP documents, SOPs, protocols, batch records, and validation documents.
• Clinical, research, or pharmaceutical experience is a plus.
• Technical writing experience within a scientific environment is a plus.
• Experience with e-DMS and e-QMS systems.
• Relevant IT skills (Word, Excel, Visio, Microsoft Project).
  
  

Work Environment

Shift: Monday to Friday, 1st shift. The role involves working within the QA Department. The work environment includes collaboration with cross-functional departments and the use of advanced document management systems.

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 Feb 14, 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 ( actalentaccommodation@actalentservices.com) for other accommodation options.