Our global medical device client located in Irvine, CA is seeking an Associate Documentation Specialist.
* Ensure appropriate and necessary documentation is in place to meet corporate Quality System in compliance with regulatory requirements.
* Review change package against governing procedures interact with departments to complete the change package and release final change package.
* Perform incorporation of approved changes to documentation (e.g. JDE data entry and verify correct implementation)
* Participate in special projects, complete assigned tasks, and deliverables
* Evaluate changes proposed by initiators and provide feedback.
* Other incidental duties assigned by Leadership
* Strict attention to detail
* Good computer skills in usage of MS Office Suite
* Good written and verbal communication skills and interpersonal relationship skills
* Good problem-solving and critical thinking skills
* Experience with project management and project management software tools preferred
* Good knowledge and understanding of corporate policies, procedures, and regulatory (e.g., medical, pharmaceutical) guidelines relevant to documentation
* Good understanding of medical device documentation development activities
* Ability to manage confidential information with discretion
* Ability to interact professionally with all organizational levels
* Ability to manage competing priorities in a fast-paced environment
* Adhere to compliance with internal procedures
* Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness
* Adhere to all company rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Education and Experience:
* Bachelor's Degree in related field with 1 Year related experience OR
* Associate's Degree or equivalent in related field with 3 Years related experience.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.