Quality Assurance Specialist

• Provide Quality oversight and support as needed by Quality customers.
• Support and partakeinQuality Management SystemProcesses such as:

Document Control Program: review approval and maintenance of company Standard Operating Procedure via electronic Document Quality Management System. Ensuring stakeholders are adhering to company policies and templates.

Change Management Program: Review approve and track changes to approved procedures validated software and processes qualified equipment. Review the change task completion. Track and facilitate investigation in cross functional impacted teal to support closure of Change Control.

Deviations and Nonconformances: Review approve and monitor the events and deviations. Complaint handling and investigations Track and facilitate investigation in cross functional team discussions in support of closing Quality Events

Supply/ Vendor Management: Supplier qualification reassessment activities quality agreements quality score cards. Oversee the process is maintained and approved according to processes.

Validations: Review and approval of equipment systems validation/ qualification and any design transfer to operations

Quality Metrics: Perform trending analysis and reporting of quality indicators. Identification or risk and process improvements into operations.

Reviews chart and medical records for completeness of all required testing and documents for various processes.

Compliance: Audit plan and reporting to applicable standards. Review and approval of corrective action and supporting evidence. Aid in audit hosting and preparation. aid in tracking and trending of internal and external findings investigation and implementation of corrective/ preventive measures.

• Perform data entry data analysis tracking trending creating graphs and reports as required for each Quality Management System modules monitoring timeliness and effectiveness.
• Perform compliance review on executed records from completeness of all required testing and documents for various processes.
• Maintain understanding of root cause analysis techniques to help quality customers with investigation of complex matters on root cause analysis techniques and processes.
• Identification of risk and risk mitigation
• Work cooperatively in a team environment to maintain cross functional and cross site processes and procedural consistency for quality systems records.
• Recognizes errors in records and resolves them in a timely manner.
• Perform other Quality Assurance Duties as required.

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Knowledge Skills and Abilities:

• Understands and applies comprehensive knowledge of quality principles and maintains current understanding of regulations.
• Familiarity or experience with the following is strongly preferred: Basic statistics review/approval of documentation; risk tools technical writing and writing/reviewing/approving investigations.

Computer Skills:

• Knowledge of Master Control or similar eQMS a plus
• Demonstrated experience and proficiency in Microsoft Office applications Word Excel and PowerPoint.

Adaptability

• Responds effectively to changing constraints.
• Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
• Understands the drivers of change and anticipates the implications of changing political and practical circumstances
• Applies a preventative instead of corrective approach Attention to Detail
• Checks information picks up inconsistencies and mistakes and can make detailed comparisons between similar sources
• Positive work attitude that supports teamwork and continuous improvement.

Decision Making

• Makes pragmatic decisions based on range of factors
• Able to make decisions quickly where necessary based on incomplete information
• Demonstrates logic to back up decisions
• Excellent critical analytical skills ability to find root cause of why and issue occurred.

Initiative

• Identifies ways to improve processes/situations
• Takes responsibility for improvements or solving problems.
• Must display eagerness to learn and continuously improve.
• Sets own standards above prevailing standards shows dissatisfaction with substandard or inefficient activities Interpersonal Skills
• Socially capable interacts confidently reads the situation
• Empathetic and can evaluate likely reactions
• Collaborative approach

Results Oriented

• Ability to focus on important issues only. Risk based approach
• Regularly refocuses on results
• Demonstrates a drive to exceed performance targets

Task Management

• Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion
• Prioritizes and monitors tasksprogress
• Makes realistic estimates of time and resource requirements

Work Environment:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger handle or feel; and reach with hands and arms. Specific vision abilities required by this job include close vision.

Education:

• Bachelors degree (BA) from fouryear college or university or Associates degree (A.A. with three to five years related experience and/or training.

OR four to six years related experience and/or training; or equivalent combination of education and experience