Quality Assurance Specialist

12 hours ago

Kalamazoo, Michigan, United States Octapharma Plasma Full time

Unlock Your Career Potential

We're Octapharma Plasma, a leading company in the plasma industry, and we're growing fast. If you're looking to expand your career-development potential, enhance your ability to help donors and patients, and gain access to professional opportunities, we encourage you to consider this exciting role.

About the Role

This is a unique opportunity to join our team as a Quality Assurance Technician. As a key member of our team, you will be responsible for maintaining compliance with SOP, current Good Manufacturing Procedures (cGMP), and regulatory guidelines. You will perform QA reviews of external sample/product shipment releases, training records, and deviation reports, ensuring the Donor Center's licenses and certificates are in-date and valid.

Your Responsibilities

  • Maintain compliance with SOP, cGMP, and regulatory guidelines
  • Perform QA reviews of external sample/product shipment releases, training records, and deviation reports
  • Ensure the Donor Center's licenses and certificates are in-date and valid
  • Perform audits for self-assessment evaluation, monitor records, and overall compliance related to the company quality systems
  • Attend and assist in all audits and ensure that all audits (internal and external) are performed, documented, reviewed, and closed
  • Assist in maintaining the established quality system under any requirements that affect the center and help ensure that all operations in the center are in compliance with the company's quality program
  • Assist in, conducts, and evaluates center training and orientation programs

What We're Looking For

  • Part brand ambassador, part clinical technician
  • A person committed to excellent customer service all day, every day
  • Someone with positive energy, always willing to pitch in where needed
  • Understanding, patient, and genuinely authentic
  • Able to keep up in a fast-paced environment
  • Hungry to build a great career

What It Takes

  • Associates degree in applicable field of study preferred or equivalent job experience
  • Must have a minimum of one (1) years related work experience, preferably in a donor center
  • One (1) year work experience in biologics quality assurance preferred
  • General computer skills, organizational skills, and detail-oriented
  • Possess adequate communication skills and be able to effectively communicate with people of all levels

Why Choose Us

  • Formal training
  • Outstanding plans for medical, dental, and vision insurance
  • Health savings account (HSA)
  • Flexible spending account (FSA)
  • Tuition Reimbursement
  • Employee assistance program (EAP)
  • Wellness program
  • 401k retirement plan
  • Paid time off
  • Company paid holidays
  • Personal time

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