Admin - Spec Documentation
Admin - Spec Documentation
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Job Description
Summary: The Documentation Specialist is responsible for ensuring the proper documentation is in place to meet regulatory requirements and maintain compliance with quality systems.
Key Responsibilities:
- Review and evaluate change packages against governing procedures collaborating with various departments to finalize and release the documentation.
- Incorporate approved changes into relevant documentation including data entry and verification of correct implementation.
- Participate in special projects meeting deadlines and deliverables as assigned.
- Provide feedback on proposed changes from initiators and evaluating their impact; Also Perform other duties as assigned by leadership.
Independence & DecisionMaking:
- Work independently with minimal supervision making informed decisions based on guidelines and procedures.
- Evaluate potential risks and recommend appropriate courses of action after considering various alternatives.
- Offer guidance to lowerlevel personnel when necessary ensuring tasks align with overall objectives.
- Demonstrate sound judgment in problemsolving and decisionmaking ensuring compliance with standards.
Skills & Qualifications:
- Proficient in Microsoft Office Suite and project management software.
- Strong communication skills (both written and verbal) and interpersonal abilities.
- Critical thinking and problemsolving expertise.
- Familiarity with medical device documentation regulatory guidelines and internal procedures.
- Ability to handle confidential information with discretion.
- Strong attention to detail and ability to manage multiple priorities in a fastpaced environment.
- Knowledge of safety health and environmental (EHS) requirements and compliance.
Education & Experience:
- Bachelors degree in a related field.
- 24 years of relevant experience in documentation and quality control.
Trinus Corporation a leading provider of technology solutions and services with over 25 years of experience is a certified WBE/MBE/SBE/SDB firm accredited by WBENC NMSDC and SBA. Our mission is to shape the future of work by aligning the right mix of people process technology and innovation to efficiently meet our clients business objectives. At Trinus we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit. To learn more about us please visit our website
Employment Type
Full Time
