Quality Assurance Coordinator

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Overview:
Business Title:  Quality Assurance II
Position Title: Quality Assurance Coordinator
Division: Consumer Products Services 
Entity: Galbraith
Location: Knoxville, TN
Reports to: Senior Manager, QHSSE
FLSA: Non-Exempt
 
Hours Worked: Typically, Monday through Friday (10 AM-6:30 PM), forty-hours per week. 
However, must be flexible to meet the needs of the department and complete other projects as assigned.

Position Summary:
The Quality Assurance Inspector/ Coordinator provides support to the operation to ensure Quality Assurance (QA) objectives are met. This position also functions as the primary Document Control Clerk and provides support for the quotation process and performs Reportable Result System (RRS)entry/verification. 

Duties and Responsibilities:
•    Data Management: Enters and maintains data in databases such as RRS, ensuring data integrity and accuracy.
•    Document Production: Creates and manages documents using Word, Excel, Nitro PDF Pro, and other software applications.
•    Data Organization: Organizes, maintains, and consolidates data within established protocols and standards.
•    Document Control & Archiving: Manages and archives critical records including:
o    Contract filing and archiving
o    Equipment calibration records
o    Calibration and maintenance logbooks
o    Manual of Practice documentation
o    Method summaries following operational approval
o    Employee and third-party training records
o    Management review documentation
•    Quality Management System Documentation: Oversees documentation through the quality management system, including:
o    Standard Operating Procedures (SOPs)
o    Validation and verification methods
o    Analytical procedures
o    Employee job descriptions and curricula vitae
•    Quality Incident Management: Maintains and manages the quality incident log.
•    Regulatory Communication: Notifies clients of regulatory inspections.
•    Corporate Document Management: Directs, files, and manages corporate documents such as quality agreements, NDAs, and other confidential materials.
•    Quality System Documentation: Organizes, files, and stores quality system documentation and quality records in accordance with regulatory requirements.
•    Process Improvement: Identifies gaps in document control processes and recommends improvements to enhance efficiency and compliance.
•    Quality Assurance: Performs QA inspections on analytical data and reports to ensure accuracy and regulatory compliance.
Skills & Proficiencies:
•    Able to use MS Office Pro software.
•    Able to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.  
•    Able to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.  
•    Able to write routine reports and correspondence.  
•    Ability to perform multiple tasks
•    Ability to organize and prioritize workloads to meet or exceed deadlines
•    Have a very high level of attention to detail.
•    Have a positive attitude, be self-motivated, and maintain a high level of engagement.
•    Able to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.  
•    Able to use statistical analysis tools
•    Able to review and understand regulatory requirements such as FDA cGMP. 
•    Able to define problems, collect data, establish facts, and draw valid conclusions.

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Education and Experience:
•    Degree requirement: Bachelor's Degree in a Chemistry or related field.
•    Minimum of one (1) year of experience in quality assurance or related scientific industry.

An equivalent combination of education and experience may be accepted in lieu of above.

Compensation Range:
$20 - $21 an hour (e.g., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as locations, education, experience, and skillset). 

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