Quality Assurance Manager Plasma Donation Center

Olgam Life; New York (NY); On-site; USD 80,000 - 85,000; Full time

Benefits offered by this job

Paid Training

Paid PTO

Job summary

Olgam Life is seeking a Quality Assurance Manager to oversee QA processes within our plasma collection facility. You will ensure compliance with FDA regulations, CGMP, ISO 13485, and HACCP, driving quality improvements across operations and donor care.

Responsibilities include developing QA policies, conducting audits, managing documentation, training staff, and collaborating with cross-functional teams to maintain the highest standards of quality and safety in every step of the process.

Qualifications

• Bachelor's degree in a related field; advanced degree preferred.
• Experience in quality assurance management within healthcare or pharmaceutical industry.
• Knowledge of FDA regulations, CGMP, HACCP, and ISO 13485.
• Strong project management and leadership abilities.
• Attention to detail during quality inspections.

Responsibilities

• Develop and implement QA policies to ensure FDA and ISO 13485 compliance.
• Conduct regular quality audits and inspections.
• Manage quality control processes and reporting of findings.
• Collaborate with cross-functional teams to improve operational processes.
• Provide training on QA practices and regulatory requirements.
• Monitor CGMP compliance across plasma collection and processing.

Skills

Quality assurance management

Project management

Regulatory compliance

Analytical skills

Cross-functional collaboration

Education

Bachelor's degree in a related field

Advanced degree preferred

Job description

Company Overview

Olgam Life is a leading plasma donation center dedicated to making a significant impact in the healthcare industry. Our mission revolves around providing a safe and comfortable environment for donors while utilizing advanced technology to ensure high-quality plasma collection. We are committed to fostering a supportive community that enhances health and improves lives.

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.