Quality Assurance Manager

4 weeks ago

Houston, Texas, United States Proesis Bio Full time

At Proesis Bio, we are dedicated to improving the plasma donation journey for all stakeholders. Our team partners with communities and donors to supply the industry with high-quality plasma necessary for treating people with rare and chronic conditions worldwide. We strive to create a collaborative and engaging culture focused on bold authenticity, intense curiosity, and innovation, fierce donor advocacy, and growth.

Job Summary

The Quality Assurance Manager will work onsite in our brand new Houston, TX plasma donation center to oversee all quality-related aspects of the center and its processes. This position works alongside the center staff and leadership to collaborate with the corporate quality team to ensure donor safety, suitability, and product quality.

Key Responsibilities
  • Cultivate a culture where Proesis' four core values are embraced.
  • Collaborate with the Corporate Quality Assurance team, Corporate Operations team, and Center Director to ensure donor safety, donor suitability, and product quality.
  • Direct and monitor processes and ensure center compliance with all applicable state, federal, and company-designated regulations.
  • Ensure Standard Operating Procedures (SOPs) are correctly interpreted and implemented appropriately.
  • Review and remedy any compliance issues with appropriate staff and their supervisors.
  • Continuously assess, promote, and improve the effectiveness of quality systems in the donor center through identifying trends, performing root cause analysis, documenting findings, and suggesting appropriate corrective action.
  • Actively participate with the Center Director in community organizations and events related to advancing the Proesis Bio mission.
  • Build rapport with employees and donors to ensure overall customer satisfaction.
  • Collaborate with the Center Leadership Team (CLT) on recruiting, hiring, and onboarding new team members.
  • Serve as an alternate to the Center Director as needed.
Requirements
  • Bachelor's degree, or equivalent experience, with a minimum of two years' experience in manufacturing, biologics, or blood products.
  • In-depth knowledge of the human source plasma industry preferred.
  • Outstanding analytical, problem-solving, and organizational abilities.
  • Exceptional verbal and written communication skills.
  • Comfortable with ambiguity in a fast-paced growth environment.
  • Experience in a start-up environment is a plus.
  • Enthusiastic about the opportunity to build innovative and efficient processes.
  • Ability to travel up to 25% of the time.
  • A background and passion for Regulatory, Quality Assurance, and Operations with a focus on strong interpersonal relationships.
Physical Demands
  • Ability to sit or stand for extended periods for up to four (4) hours at a time.
  • Ability to tug, lift, and pull up to fifty (50) pounds.
  • Be able to bend, stoop or kneel and climb stairs or ladder.
  • Occupational exposure to bloodborne pathogens.
  • While performing the duties of this job, the employee is regularly required to stand; use hands to, handle or feel objects, tools, or controls.
  • The employee must be able to enter a walk-in freezer at the Center with a temperature of -40 Celsius for short periods of time.
  • Specific vision and hearing abilities are required to be successful within the role.

At Proesis Bio, we celebrate diversity and strive to create a collaborative and engaging culture. If you are passionate about quality assurance and have a background in biologics or blood products, we encourage you to apply for this exciting opportunity.

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