Document Management System Specialist (Pharma, Hybrid)

  • Contract Duration: 6+ months
  • Manufacturing
  • Cambridge, MA

Website Lenox Executive Search

Job description

6+ month CONTRACT role. Requires onsite work in Cambridge, MA. 4 days per week with 5th day remote. Looking for someone who enjoys working in a casual environment but is able to show good judgement and quickly adapt and flex when needed.

Lenox Executive Search is seeking an experienced Document Control Specialist to fill an 6+ month contractual role with a global pharmaceutical company in Cambridge, MA. Seeking a creative, resourceful, integrative thinker for an important role as a Document Specialist Consultant, responsible for organizing the life cycle of documents in the electronic Document Management System, as well as maintaining the Quality Systems archive of records, stored both onsite and offsite. Must be able to pivot under stress!

REQUIREMENTS for the Document Control Specialist:

  • Bachelor’s degree with 2+ years of applicable experience either in pharmaceutical drug development/life sciences/biotechnology and/or records and archive management.
  • Proficient with using MS Office (e.g., Word, Outlook, SharePoint, Excel).
  • Strong Customer Service mindset
  • Document Management system (eDMS) experience (SharePoint preferred)
  • Must be able to lift file boxes which weigh 25-35 lbs.
  • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
  • Must be able to effectively pivot under stressful situations.
  • Be able to effectively communicate with various stakeholders and Quality Assurance team members at varying levels throughout the organization.
  • Excellent organizational skills, exceptional attention to detail, diligence, and flexibility as well as be able to prioritize responsibilities and adhere to deadlines.
  • Outstanding communication skills (interpersonal, verbal, and written) and collaboration skills
  • Must be willing to work onsite 4 days a week.

NICE TO HAVE:

  • Expertise with Visio, and Acrobat Pro preferred
  • Experience working in Veeva Vault Quality Docs a big plus
  • Experience with quality systems and activities at all phases of the Product Lifecycle and knowledge of GxP regulations, particularly pertaining to quality systems requirements preferred

RESPONSIBILITIES of the Document Control Specialist:

  • Maintain logs and document inventories to ensure chain of custody traceability.
  • Oversee upload of records into the electronic Document Management System (eDMS) in compliance with regulatory requirements.
  • Support program efforts for Certified Copy creation, which may include scanning and reviewing the replica based on established standards.
  • Maintain inventory and indices of onsite and offsite GxP documents and records.
  • Provide support during internal and external audits related to Regulatory and internal audits for Documentation.

Job Type: Contract

Salary: $30.00 – $38.00 per hour

Schedule:

  • 8 hour shift
  • Monday to Friday

Ability to commute/relocate:

  • Cambridge, MA: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

  • Are you able to lift boxes weighing 25-35 pounds?
  • Are you vaccinated?

Education:

  • Bachelor’s (Required)

Experience:

  • SharePoint: 1 year (Preferred)
  • Document management: 2 years (Preferred)
  • eDMS-Document Management system: 1 year (Preferred)
  • Excel: 1 year (Preferred)
  • Microsoft Outlook: 1 year (Preferred)
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Our COVID-19 Policy

As with other larger employers and customer-facing organizations, Lenox Executive Search is carefully monitoring the situation regarding Coronavirus (COVID-19), with a particular focus on public health guidance offered by the CDC and state officials.  We are reaching out to make you aware of our activities and preparations in light of the spread of the Coronavirus (COVID-19). Our number one priority is the safety of our employees, clients and the broader community. Given the current unpredictable nature of the spread of COVID-19, and in an abundance of caution, Lenox Executive Search has implemented the following practices immediately:
  • We have increased our overnight cleaning activities to ensure frequently touched areas are being disinfected and sanitized.
  • We have implemented social distancing techniques to minimize the typical face-to-face- contact by utilizing teleconference calls and flexible workspaces.  We have suspended non-essential business travel for our employees and have asked that inter-company meetings be conducted via teleconference. In addition, we kindly ask all of our customers to help us maintain a handshake-free zone at all Lenox Executive Search locations.
  • We have asked employers who feel ill to stay home.
  • We have convened a team of senior leaders who meet daily to discuss the situation and stand ready to take additional steps, if necessary.
  • We have measures in place to ensure our operations can effectively continue so that we can provide our clients uninterrupted service.  Lenox Executive Search already had robust and detailed business continuity plans in place.
– The Lenox Executive Search Team