CMC Document Specialist - United States
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PerkinElmer is a global technology leader driving growth and initiative in the Environmental and Human Health Science markets. The company is a leading force in the development, production, marketing, servicing, and support of laboratory instrumentation and ancillary services throughout the world.
Job Title: CMC Document Specialist
Location: Lexington, MA
Duration: Long term
- Under the direction of the line manager, the Contract R&D Pharmaceutical Development Documentation, Training and Compliance Specialist is responsible for supporting all the documentation and training needs.
- Provide documentation and training coordinator services to the PD department including numbering, version control, formatting, processing, and filing of documents.
- Update training profiles, maintain training records and submit document records within our electronic training tracking system.
- Assist with documentation and training projects.
- Document issuance, version control, manual and electronic files maintenance, and document status notifications.
- Creating monthly metrics.
- Follow-up on documents biennial review process.
- Perform logbook creation, review, scan, and file function.
- Document formatting, printing and update document trackers.
- Create training profiles, update training profiles on paper and electronic system, create training reports, maintain training metrics, etc.
- Perform administrative functions in our training tracking system: update training profiles, updates documents records, etc.
- Assist with training and documentation projects.
Education and Experience Requirements
- Bachelor’s degree required.
- Experience in Biopharmaceutical industry is preferable.
- Documentation experience required (paper-based and as well as electronic system).
- Training system experience required (paper-based and as well as electronic system).
Key Skills, Abilities, and Competencies:
- Minimum 1 year experience is required.
- Microsoft Suite detailed knowledge is must.
- Familiarity with style and formatting within MS word is must.
- Microsoft Excel pivot table’s knowledge is required.
- TrackWise and MasterControl or other similar training system knowledge and experience is must.
- Must be able to work independently but also be customer service oriented.
Complexity and Problem Solving
- Emphasis on excellent customer service.
- Must be able to work independently.
- Prioritization decisions will be made by line manager.
- Able to solve problems and escalate issues to line manager.
Other Job Requirements:
- Working hour’s flexibility to meet deadlines as needed.
- Ability to work overtime as needed.
Benefits at PerkinElmer
Competitive base salary and incentive compensation plan / Job training and professional development / Comprehensive benefits package / Paid time off and holidays / Tuition reimbursement plan / 401(k) with match