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Title: Quality Specialist – DMS Administrator
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration – Contract – Long Term
- Pay rate: $40/hr.
- Job Location: Boston, MA
- Job#: bh12569
Quality Specialist, GPOC Document Management System (DMS) Administrator
- At least 3-5 years of relevant work experience
- Experience working in Electronic Document Management Systems (Doc Compliance, Veeva, Documentum)
- Comfortable leading reviews of Quality and GxP SOPs, Work Instructions, forms and templates
- Excellent communication skills; Interacts with internal and external customers and functional groups at various management levels to provide customer service
The Quality Specialist is responsible for performing multiple activities in support of their group or clients under minimal supervision. The Specialist applies technical proficiency and attention to detail in “troubleshooting,” as well as the ability to interpret and execute project plans, and lead initiatives with minimal guidance.
GENERAL RESPONSIBILITIES AND REQUIRED SKILLS:
- Presents a solid understanding of quality assurance concepts and practices
- Demonstrates emerging knowledge of applicable regulations and the interpretation and application of regulations and compliance concepts
- Exercises independent judgment to optimize some commonplace compliance procedures
- Displays an emerging ability to manage client expectations
- Displays effective communication skills (written and verbal), within their area(s) of expertise
- Demonstrates proactive thinking and actions
- Reviews and may be responsible for authoring SOPs and Work Instructions, with minimal supervision
- May act as a representative of their Quality division on assigned project sub-teams and/or task forces
- Demonstrates emerging skills in influencing others within project teams regarding quality or compliance concerns
- Displays an emerging ability to develop innovative ideas for solving problems
- Has the ability to read and respond to audiences appropriately
- Performs other duties as assigned
- Dedicated DMS Document Control Representative
- Independently manages the full life cycle of the Document Control processes including
- QA Documents (SOPs, WIs, Forms, etc.)
- CMC Documents (Quality Standards, Analytical Methods, Specifications, Batch Records, etc.)
- Document Distribution
- Recognized as a technical resource within their discipline; answering questions and requests related to the DMS (CMC, QA, System Downtime, etc.) and incidents and service requests
- DMS Business Owner responsibilities
- Attend weekly meetings
- Conducts reviews of Quality and GxP SOPs, Work Instructions, forms and templates
- Proactively identifies opportunities for process improvements in the Document Control program and works cross functionally to implement, as appropriate
- Maintains user training materials for new users of the document control computer systems and business processes
- Interacts with internal and external customers and functional groups at various management levels to provide customer service
- May participate in regulatory inspections or due diligence activities, as requested
- May participate as document control representative on internal and external cross functional projects driven sub-teams
- Performs other duties as assigned
PREFERRED EDUCATION AND EXPERIENCE:
- B.S. in a scientific or allied health field (or equivalent degree) and 3 – 5 years of relevant work experience, or
- Relevant comparable background
Experience working in Electronic Document Management Systems (Doc Compliance, Veeva,
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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