Essential Duties : GLP Studies (When necessary)
- Audit a portion of each GLP study.
- Review each GLP study and final report prior to release to the Sponsor. GCP Studies (When necessary)
- Audit a portion of each GCP study.
- Review each GCP study and final report prior to release to the Sponsor. Regulatory Policy & Procedural Guidance
- Know and follow GLP, GCP and relevant ISO regulations.
- Review and approve discontinued studies.
- Review and approve amended reports.
- Review and approve quality events (QEs).
- Initiate, investigate, identify corrective / preventive actions, and verify CAPA. Process Improvement
- Audit studies in process.
- Review validation protocols, raw data, and reports.
- Implement corrective / preventive actions as a result of quality trend review.
- Involved in staff training on quality concerns or process improvements Audits
- Conduct audits in accordance with the applicable audit schedule
- Perform GLP audits when necessary.
- Perform GCP audits when necessary
- Perform external audits, if requested by the QA Manager. + Involve pertinent staff to facilitate knowledge transfer. + Conduct a tour of the facility as requested by the auditor.
- Provide necessary documents and information to the auditor as requested. + Assist with any follow up needed after the live or remote phase of the audit.
- Prepare or complete information for written audit requests. + Prepare responses to audit reports.
- Perform internal audits + Sample items to audit based on risk to the company and failure modes of the system. + Review and ensure findings are properly classified and apply the appropriate level of action necessary based on risk.
- Ensure audit reports are completed, distributed, and all action items closed prior audit file closure.
- Performs random inspection audits. + Review data from in-process studies + Observe in-process testing and / or laboratory environment Record Review
- Conduct a review of applicable logbooks at appropriate time intervals. Quality Metrics
- Trend quality metrics to identify positive, negative, and steady trends.
- Compile / Track quality metrics in the form of dashboards and scorecards. Regulatory Compliance
- Know and follow applicable regulatory requirements (GLP, GCP, ISO, etc.).
- Know and follow company policies and procedures.
- Complete required training on time. Professionalism
- Attend work regularly and reliably.
- Adhere to all policies and procedures.
- Perform other duties as assigned. Competencies of this position
- Knowledge of GLP, GCP, and ISO 17025 regulatory requirements
- Attention to detail
- Effective critical thinking, problem solving, and decision-making skills
- Knowledge of trend analysis to identify and act on recurring issues
- Ability to be proactive in continuous improvement of systems, processes, and procedures
- Proficient in Microsoft Office products
- Ability to work collaboratively with customers, staff, and management
- Ability to accept constructive criticism
- Ability to implement actions and learn quickly from feedback
- Seek input from others to make decisions
- Solution driven
- High standards of honesty, integrity, and quality
- Professional, courteous, and helpful attitude
- Conflict management skills.
- Excellent response times and service for internal and external customers
- Ability to organize and manage workload.
- Ability to communicate internally and externally in a clear and objective manner
- Ability to work independently Qualifications Work Environment : This job operates in a professional office and laboratory environment.
This role routinely uses standard office equipment such as computers, keyboards, computer mouse, telephones, photocopiers, projectors and file cabinets.
Wear personal protective equipment such as lab coats, safety glasses, gloves, facemasks, as applicable. Physical requirements : Must be able to spend 30-40% standing and walking the lab on audit days and 10% on non-audit days.
Must be able to sit 60-70% on audit days and 90% on non-audit days and 50% on the computer on audit days and 90% on the computer on non-audit days.
Also, must be able to lift a minimum of 20lbs. Education and experience requirements : High School Diploma or equivalent and two years quality or lab experience OR a B.
S / A.S with one-year quality or lab experience.
CQA or equivalent.
SQA or ASQ certification preferred.The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company's unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry.
With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.
Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality.
We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.
Sotera Health goes to market through its three best-in-class businesses - Sterigenics®, Nordion® and Nelson Labs®.
Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets.
Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process.
Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.
Learn more about Sotera Health at soterahealth.com.
