Document Control Specialist

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Job Description:

• The Lead Document Controller will be primarily responsible for the control, review, release, archiving/storage, and obsolescence of documentation for client site(s), including procedures and specifications.
• The Lead Document Controller will also be responsible for assisting with sites periodic reviews, CIDTs, and post release tasks to ensure completion in accordance with the applicable regulatory requirements and standards.
• Responsible for all activities related to document routing, distribution and release to assure that the latest effective copies are available as required.
• Ensure prompt archiving and storage of applicable client documentation.
• Provides timely retrieval of documents and information, as needed to complete investigations, audits and/or reports.
• Acts as Subject Matter Expert for document control related activities and processes for the franchise.
• Develop and provide coaching, training, clinics, support and service to functions in use of and navigation of the PLM system and execution of documentation & change processes.
• Lead and drive improvement initiatives within the Quality Systems team and participate in multi-functional teams to achieve collaborative results.
• Act as a single point of contact for process owners during the implementation of external client Documents into local QMS, including the CIDT process.
• Report on, input to & maintain quality KPI’s for client site(s) including periodic review, CIDT process, supplier notifications and Change activity RFT for trending / management reviews.
• Assist in issue investigations, provide input to correction & resolution, rework, problem solving, and process improvements.
• Assist with company regulatory audit activities, as deemed necessary.
• Acts as a backup to the Change Specialist.

Education & Special Training:

• Working towards Bachelor’s Degree or higher level education equivalent (required)
• Bachelor’s Degree – United States of America & Ireland (Preferred)
• EQF Level 6 or equivalent– EU

Qualifications &

Experience:

• Minimum of 4 years in a Quality/Regulatory Affairs environment with 2 years experience in Document Control or other related function or 0-1 year experience in a Quality/Regulatory Affairs environment with Bachelor’s Degree or equivalent
• Ability to gain knowledge and understanding of US and International Medical Device Regulations (ISO 13485, MDSAP, and CFR Part 820 Quality System Regulations desired)
• Ability to gain knowledge of supporting Quality Systems (e.g. Audits, Management review, Quality Planning).
• Ability to demonstrate basic communication, identify problems, recognizes areas for improvement and contribute to data management and training
• Ability to follow instructions, complete task with supervision, identify urgent task and address immediate conflicts
• Understands basic regulatory concepts, recognizes industry standards and can identifies key regulations.
• Understands basic communication principles, understands the importance of their input and participates in group discussions.
• Participates in virtual team meetings and eagerness to understand roles within a team.
• Provides updates to supervisors, Shares information with team members, Collaborates with peers.
  • Understands data concepts and identifies basic actions from data.
• High level of PC skills required.
• Fluent in written and oral English - B2 Level (writing documents, meeting minutes, conference calls, etc.)

• Mid-Senior level

• Contract

• Quality Assurance

• Medical Equipment Manufacturing
• Pharmaceutical Manufacturing

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