CMC Document Specialist

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.

• 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.

• 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).

• 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.

• 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.

• 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