Quality Systems Specialist
Quality Systems Specialist
Posted on :
24-12-2024
Employer Active
1 Vacancy
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Job Description
Quality Systems Specialist responsibilities include but are not limited to the following:
- Under the direction of the Manager of Regulatory Affairs and Quality Assurance this position will assist with maintenance of the Eurofins CellTx Quality Management System (QMS).
- Initiate investigate close track trend and verify effectiveness of actions with the QMS components such as quality events (including deviations complaints nonconformances and investigations) audit corrective action records (ACARS) and Corrective and Preventive Actions (CAPAs). Identify high level trends that have an impact to the organization and escalate the issue/incident appropriately.
- Lead and/or assist in representing Eurofins CellTx with hosting external auditors (client and regulatorybased audits). Provide external auditors with requested information ensure documentation is complete and accurate and collaborate with operational staff for tours and interviews.
- Assist with facilitation of the licensing accreditation and/or certification process.
- Provide training and support to inter and intra departmental employees. Lead and mentor employees with the various Quality System elements; Assist in New Employee Orientation programs organizationalwide training and individual training for elements including but not limited to: Good Documentation practices (GDP) Manufacturing Tissue Practices QMS components applicable regulatory standards annual procedure review Document Control Record Review/ Record Management Training Program elements and customer satisfaction.
- Assist and facilitate in the development of planned and systemic processes for Continuous Quality Improvement (CQI) throughout the department and organization. Assist in developing long range continuous improvement plans to accomplish quality; evaluate and provide suggestions to improve system efficiencies and effectiveness.
- Develop and monitor relevant Quality Indicators for the Quality System to be used an input into the Quality Management Review process.
- Serve internal and external customers as a consultant. Assist management in addressing business needs in quality or regulatory areas by guiding identification of cause finding best solution supporting implementation and monitoring.
- Perform duties and tasks in a timely and compliant manner ensuring accurate documentation and conclusions.
- Maintain and utilize sound working knowledge of all program regulations standards and policies; keep current with all relevant federal state and local regulations recalls and guidance.
- Ensure all established procedures (OPs methods etc.) and regulatory standards are adhered to at all times. Develop or revise standard operating procedures and laboratory policies as applicable.
- Assist in organizing and facilitating regularly scheduled training with managers supervisors team leaders and staff as needed to educate/ collaborate and implement quality principles and corporate compliance as a strategy.
- In order to meet Eurofinss quality policy and goals/objectives all employees are expected to meet basic expectations of Eurofinss quality management system including but not limited to good workmanship adherence to standard operational procedures training good documentation practices and accurate recordkeeping.
- Exhibit support of Eurofins CellTx business philosophy leadership values quality objectives ethical behaviors customer care and confidentiality standards at all times. Foster a positive work environment modeling professional behavior.
- Other duties as assigned when necessary
Qualifications :
Minimum Educational Qualifications:
- Highschool Diploma
- Associates degree in a healthcare business or related field or Bachelor degree in Life Science preferred
Minimum Qualifications:
- Minimum 13 years of quality laboratory and/or regulatory experience in a regulated industry
- Experience with regulatory and/or accrediting agencies (e.g. FDA ISO AABB CLIA) preferred
- Ability to work effectively under the expectations of Quality System expectations
- Willing to travel to satellite locations for quality support internal audits and regulatory inspections (25% travel)
- Quality Auditor certification (ASQ or equivalent) desired
- Advanced analytical and problems solving skills
- Computer skills in Word Excel email required. Database management and/or development skills helpful but not required
- Ability to work in controlled environments
- Highly developed organizational and multitasking skills
- Possess a high level of integrity (professional diplomatic confidential) with demonstrated interpersonal skills with the ability to interface well with employees with other departments (and within the QA department)
- High level skills in oral and written communications
- Authorization to work in the United States indefinitely without restriction or sponsorship
Potential Environmental Factors:
- This laboratory carefully maintains all hazardous materials. All employees must abide by Eurofins CellTx Safety and Exposure procedures. This includes using the provided safety clothing and equipment
- For a list of potential chemical hazards see appropriate SDS sheet
Additional Information :
Position is fulltime working between Monday Friday 9:00am 5:30pm with overtime as needed. Candidates currently living within a commutable distance of Tucson AZ are encouraged to apply.
- Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
Key Skills
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