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Quality Assurance Analyst

Advarra

This is a Contract position in Fort Collins, CO posted September 12, 2021.

General Summary: The Document Control / QA Analyst at Advarra, Inc.

is responsible for document control and quality management system administrative activities at Advarra.

The role is accountable for helping establish and improve quality practices for our document control processes and the quality assurance document management system.

In the role of Document Control / QA Analyst, this individual will be responsible for Advarra’s controlled documents, Quality Management System, supporting the quality management plan, and monitoring performance measures for the quality program.Principal Duties & ResponsibilitiesDevelops and is responsible for control, security, accessibility, and timeliness of organizational documents, such as policies, procedures, guidelines, forms, templates, and training materials.Ensures documents in the Quality Management System are up-to-date and reviewed at regular intervals.Works with leaders across the organization to help develop and maintain SOPs (Standard Operating Procedures).Administers the Quality Assurance Document Management System; including managing users, groups, group permissions, document categories and documents, reporting hierarchy, approval and review workflows, review and retention cycles.Supports regulatory agency audits, client audits and accrediting body site visits.Review policies, procedures and controls for design and operating effectiveness resulting from regulatory changes, monitoring and metrics, management or client requests or other triggering events.Assists the Advarra Corporate Quality Assurance team with implementing recommendations to controlled documents arising out of audits and/or assessments.Manage and support projects and departmental initiatives that impact controlled documents.Advances the culture of quality and compliance in the Advarra business units.Acts as a change agent for Advarra’s controlled documents.Any other duties as assigned.Education Bachelor’s degree or equivalent experience.Experience3 years’ in FDA regulated, healthcare, or GxP environmentDemonstrated experience in one or more of the following:Administrating a Quality Management System (QMS) or Document Management System;Assessing processes, procedures, and system controls; andDocumenting policies and procedures.Experience with ZenQMS or a similar document management system helpful.Knowledge, Skills, AbilitiesWorking knowledge of GDP (Good Documentation Practices)Experience writing, revising, and managing Standard Operating Procedures (SOPs).Experience with broader GxP requirements, especially GCP (Good Clinical Practice), and ISO 9001 helpful.Strong computer skills with proficiency in using various computer programs (especially MS Office) and web-based applications.Strong interpersonal skills; ability to interact well and collaborate with colleagues at all levels.Excellent verbal and written communication/presentation skills with technical and non-technical staff; speaks clearly and can facilitate group discussion.Highly self-motivated and directed; demonstrated ability to plan, organize, schedule and complete work within deadlines.Attention to detail and problem-solving abilities.Ability to work both independently and in a team-oriented, collaborative environment.Demonstrates consistency and dependability in quality and quantity of work.Physical and Mental RequirementsSit or stand for extended periods of time at stationary workstation.Regularly carry, raise, and lower objects of up to 10 Lbs.Learn and comprehend basic instructions.Focus and attention to tasks and responsibilities.Verbal communication; listening and understanding, responding and speaking.EEO StatementAdvarra provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state or local law.

Further, the company takes affirmative action to ensure that applicants are employed, and employees are treated during employment without regard to any of these characteristics.

Discrimination of any type will not be tolerated.

EEO/M/F/Disabled/Vets