Bachelor's degree in a related field; advanced degree preferred.
Proven experience in quality assurance management within the healthcare or pharmaceutical industry.
Strong knowledge of FDA regulations, CGMP, HACCP, and ISO 13485 standards.
Excellent project management skills with the ability to lead initiatives effectively.
Strong analytical skills with attention to detail in quality inspections.
Responsibilities
Develop and implement quality assurance policies and procedures to ensure compliance with FDA regulations and ISO 13485 standards.
Conduct regular quality audits and inspections to assess adherence to quality standards.
Manage quality control processes, including documentation and reporting of findings.
Collaborate with cross-functional teams to identify areas for improvement in operational processes.
Provide training and support to staff on quality assurance practices and regulatory requirements.
Monitor CGMP compliance throughout all stages of plasma collection and processing.
Benefits
Paid training offered within 30 days of employment.
Paid PTO.
Days off on Friday and Saturday.
Full Job Description
Summary
We are seeking a Quality Assurance Manager to join our team at Olgam Life. In this role, you will be responsible for overseeing the quality assurance processes within our facility, ensuring compliance with industry regulations and standards. Your expertise will play a critical role in maintaining the integrity of our operations and enhancing the quality of care we provide to our donors.
Salary - $80,000 to $85,000
Days off: Friday and Saturday
Shifts start from 10 am to 6 pm
Benefits are offerred within 30 days of employment
Paid Training
Paid PTO
Responsibilities
Develop and implement quality assurance policies and procedures to ensure compliance with FDA regulations and ISO 13485 standards.
Conduct regular quality audits and inspections to assess adherence to quality standards.
Manage quality control processes, including documentation and reporting of findings.
Collaborate with cross-functional teams to identify areas for improvement in operational processes.
Provide training and support to staff on quality assurance practices and regulatory requirements.
Monitor CGMP compliance throughout all stages of plasma collection and processing.
Requirements
Bachelor's degree in a related field; advanced degree preferred.
Proven experience in quality assurance management within the healthcare or pharmaceutical industry.
Strong knowledge of FDA regulations, CGMP, HACCP, and ISO 13485 standards.
Excellent project management skills with the ability to lead initiatives effectively.
Strong analytical skills with attention to detail in quality inspections.
If you are passionate about ensuring quality in healthcare and want to make a difference in people's lives, we invite you to apply for the Quality Assurance Manager position at Olgam Life today!
