Assoc, Quality I - Clinical Trials

Job Description

This is the entry level position in the Clinical Trials Quality Assurance track. 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

Responsibilities:

Document Control & Training: 

• 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.

Qualifications:

Essential Skills

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. 

Preferred Work Experience

• 3-4 years of healthcare experience or equivalent education and experience
• Bachelor's Degree in a related scientific or technical discipline.
• Physical and Mental Requirements: 
• Ability to sit for extended periods of time.
• Ability to use fine motor skills to operate office equipment.
• Ability to receive and comprehend instructions verbally and/or in writing.
• Ability to use logical reasoning for simple and complex problem solving.

Technical /Job Specific Knowledge:

• Knowledge of Standard Operating Procedures and Quality Systems principles
• Knowledge of document control systems

Skills:

• 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.

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