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Quality Assurance Associate I entry level QA support

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Position Summary

The Quality Assurance Associate I, under direct supervision, performs activities to ensure that Flagship’s laboratory and image analysis programs meet the high quality standards of our clients and regulatory agencies.  This will include activities such as writing and reviewing Standard Operating Procedures (SOPs), reviewing study protocols and associated documentation, and assisting during audits. The Quality Assurance Associate I will also be directly responsible for maintaining the document control system and assigning SOP training.

The Quality Assurance Associate I is considered an entry level position, and will be joining a small team in a dynamic, fast-paced environment that is involved with all aspects of Flagship’s business, including clinical trials, CLIA, FDA and medical device development. The candidate should possess a strong attention to detail, ability to interact with all levels of the organization and juggle multiple tasks effectively.

Job Classification – Full time, non-exempt        Reports to:  Quality Assurance Manager

Essential Job Functions

  • Support QA Manager and QA Department in facilitating GCP/GCLP and CLIA activities
  • Basic application of FDA and CLIA regulations to activities
  • Provide support for Corrective and Preventive Actions (CAPAs) and Complaint Handling
  • Assist QA Manager and cross-functional team members with writing/reviewing SOPs, study procedures, client audit questionnaires, client audit responses
  • Maintain document and change control system, including versioning, assigning document numbers and distribution of documents
  • Provide support for Training Program by ensuring employees complete required training in a timely manner and ensuring training records are stored in compliance with record retention policies
  • Coordinate and support new hire and recurrent quality training
  • Assist QA Manager during on-site client audits, external audits, and internal audits
  • Maintain SOP review schedule and prompt authors for review
  • Conduct clinical study audits as needed on a project-requested basis
  • Assist QA Manager and Flagship internal customers to identify quality issues and improve operational processes
  • Other duties, projects as assigned

Basic Qualifications

  • Bachelor’s Degree and
  • 0-1 year experience in a regulated scientific, medical device or healthcare area
  • Proficient in MS Office (Word at an intermediate level, and Excel and PowerPoint at a basic level)
  • Superior organization skills with a focus on attention to detail and accuracy
  • Ability to manage/prioritize multiple tasks simultaneously
  • Ability to work effectively in a very fast-paced, changing environment
  • Exceptional interpersonal and communication skills, both verbal and written
  • Ability to interact/communicate effectively with team members across all departments and levels of the organization
  • Quick learner with good judgment and problem solving skills
  • Ability to work independently and as part of a team
  • Upbeat attitude and willingness to learn
  • Fluent in English, both verbal and written

Preferred Qualifications

  • Bachelor’s Degree in a science-related discipline and
  • Exposure to QA/QC and FDA regulations
  • Experience with document control system and/or writing SOPs

 

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