Assoc, Quality I - Clinical Trials at Quest Diagnostics Lewisville, TX
Behavioral Health Market Context
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Qualifications
- •Excellent verbal and written communication skills
- •Strong organizational skills; very detail oriented and a self-motivated problem solver
- •Knowledge of Microsoft Word, Excel, PowerPoint, and Outlook
- •Required Work Experience
- •0-2 years' experience in a QA role in a GLP or GCP environment
- •Knowledge of Standard Operating Procedures and Quality Systems principles
- •Knowledge of Standard Operating Procedures and Quality Systems principles
- •Knowledge of document control systems
- •Good verbal and written communication skills; strong interpersonal skills
- •Strong organizational skills; detail oriented
- •Proficiency with Microsoft Office Suite (including WORD, EXCEL)
- •To perform this job successfully, the individual must be able to perform each essential duty satisfactorily
- •The requirements listed above are representative of the knowledge, skill, and/or ability required
- •10 more items(s)
Responsibilities
- •Exercises judgement within defined areas of responsibility
- •Works on problems of limited scope; performs all duties and responsibilities with direct supervision
- •Under supervision, engages in planned and systematic activities to provide confidence that Quest is fulfilling its requirements for quality and continuous quality improvement
- •Under direct supervision, performs audits of laboratory and study records to ensure compliance with regulatory requirements and company standards
- •Under general supervision, manages the Pharma Services Biopharma Document Control Repository
- •Under general supervision, manages the Pharma Services Biopharma staff training files
- •Manage the Document Control
- •May perform periodic review of Document Control Standard Operating Procedures and forms
- •Review Document Control SOPs & provide feedback to content owner, as needed
- •Manage training files for Pharma Services BioPharma Personnel
- •Participate in the Quality Management Program including, but not limited to:
- •Participate in administrative functions of the QAU (e.g. updating records, maintaining spreadsheets, preparation of reports, filing, etc.)
- •May assist with preparation of quality indicators
- •Auditing & Inspections:
- •Under direct supervision, assist team with, or conduct study audits
- •Under direct supervision, assist with preparation of reports, as applicable
- •13 more items(s)
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