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Specialist, Document Control and Records Management

4 months ago

Burlington, Vermont, United States Randstad USA Full time
job summary:
As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you

location: Burlington, Massachusetts
job type: Contract
salary: $ per hour
work hours: 9 to 5
education: Bachelors

responsibilities:
The Specialist role supporting Document Control and Records Management will be responsible for maintaining documents in compliance with business needs and regulatory expectations in addition to supporting process improvements in the document control and records management areas. The individual will be responsible for formatting and administration of paper-based and electronic document workflows as well as chain of custody, issuance, review and archival of paper records. Excellent organizational skills, the ability to work independently on multiple tasks, and the ability to work in a fast-paced environment are required.
  • Support cross functional teams in processing document requests, document approval, and document archival.
  • Issuance and reconciliation of paper records (i.e., batch records, logbooks, protocols)
  • Manage the archival of all GMP documentation both on-site and off-site (organization and maintenance of the on-site archival room)
  • Develop and implement process improvements for Document Control and Records Management processes.
  • Assist in document control process improvements including document types, lifecycles, and workflows in eDMS.
  • Perform non-technical review of executed documents as needed to support the business needs.
  • Revise SOPs related to Document Control, Records Management
  • Collaborate with cross-functional teams to identify efficiencies around maintenance/control of paper-based documents.
  • Provide document control/records management support for internal/external audits and inspections.
  • Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
  • Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
  • Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
  • Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
    qualifications:
    • BS or MS degree, preferably in Sciences or Engineering
    • 7-10 years of Quality Assurance experience in pharmaceutical industry OR BS degree with 2-5 years of experience/MS degree with 2 years of experience.
    • Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards).
      skills: SOP, GMP (Good Manufacturing Practice)

      Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

      At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact

      Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

      Applications accepted on ongoing basis until filled.