Overview
FSQA (Food Safety Quality Assurance) Technician Jobs in Romulus, MI at DO & CO
Description:
Oncology Consultants is seeking a dedicated Research Quality Assurance Manager to oversee and execute QA activities within our dynamic Research Department. In this critical role, you’ll lead targeted audits and quality reviews to ensure compliance with regulatory standards and internal policies—safeguarding both the integrity of our study data and the safety of our research participants. If you’re passionate about advancing clinical research with precision and care, we’d love to meet you!
SCOPE:
The scope of the Research Quality Assurance Manager role at Oncology Consultants, P.A. encompasses several key areas:
Participant Safety: Ensuring the safety and well-being of research participants.
Data Integrity: Maintaining the reliability and validity of study data.
Regulatory Adherence: Complying with HIPAA regulations, IRB requirements, and other relevant guidelines.
Continuous Improvement: Enhancing the quality and efficiency of research activities through ongoing evaluation and education.
This role is integral to maintaining high standards of research quality and ethical conduct within the organization
Benefits:
Insurances: Life, medical, dental, short term and long-term disability
401K
Free parking
PTO
Holidays
Competitive salary
Employee Assistant Program
Tuition Reimbursement
Continuing Medical Education Allowance
Pet Insurance
Employee Discounts
Next Level PRIME
Requirements:
Essential Functions:
Quality Assurance Management:
Overseeing and conducting QA reviews and audits to ensure compliance with regulatory standards and internal policies.
Identifying research studies for QA reviews and implementing processes to conduct these reviews effectively
Regulatory Compliance:
Ensuring that research activities comply with applicable regulations, policies, and guidance.
Advising on the development of Corrective and Preventive Action Plans (CAPA) and assisting with regulatory submissions and reporting.
Support and Education:
Providing guidance and support to clinical researchers on regulatory aspects throughout the study lifecycle.
Developing and delivering educational programs to improve research practices and compliance.
Collaboration and Communication:
Working closely with the Research Department Director, Administrator, and other QA staff.
Communicating findings and recommendations to Principal Investigators and other stakeholders.
Problem-Solving and Improvement:
Proactively identifying and addressing issues related to research conduct and data integrity.
Implementing improvements to research processes and ensuring best practices are followed.
Investigator Consultations:
Assist with FDA inspections, FDA IND/IDE requirements, HIPAA issues, and DSMP development.
EDUCATION and/or EXPERIENCE:
Experience:
Minimum of 5 years of experience in a related field.
Education:
Bachelor’s degree required.
Skills:
Computer Skills: Strong proficiency with databases and spreadsheets.
Regulatory Knowledge: Familiarity with HIPAA regulations and experience with IRB applications.
Analytical Skills: Ability to analyze data and organize it for easy access and use.
Communication: Strong verbal and written communication skills; ability to work effectively in teams.
Attention to Detail: Meticulous attention to detail in all research processes and documentation.
Logical Thinking: Ability to implement changes in study materials and processes for future use.
Problem-Solving: Proactive in identifying and solving problems as they arise.
Medical Center | Memorial City | Sugar Land | Katy | Willowbrook | Southwest /Northwest | Southeast/League City | Pearland |Precision | Pasadena | Cypress | Corpus Christi/ Rockport
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Title: FSQA (Food Safety Quality Assurance) Technician
Company: DO & CO
Location: Romulus, MI
