(onsite) Operations Investigation Specialist

Par Health

Rochester, MI, USA
Fully remote
Quality management systems expertise
Technical writing and investigative skills
Onsite presence required
At Par Health, we believe great healthcare is built on getting the essentials right and prioritize quality and safety while fostering a culture of continuous improvement, accountability, and teamwork

Job Summary

  • At Par Health, we believe great healthcare is built on getting the essentials right and prioritize quality and safety while fostering a culture of continuous improvement, accountability, and teamwork.
  • The Operations Support Technical Writer sponsors a quality and compliance focused culture, embracing Right the First Time and Continuous Improvement expectations, and acts as a liaison between departments to drive timely resolution.
  • This role relies heavily on technical writing and investigative skills with potential to build into operational project execution in progressive roles and requires onsite presence at the Rochester, MI manufacturing plant.

Matching Summary

At Par Health, we believe great healthcare is built on getting the essentials right and prioritize quality and safety while fostering a culture of continuous improvement, accountability, and teamwork.

Skills & Requirements

Must-have

  • Quality Management Systems expertise
  • Technical writing and investigative skills
  • Onsite presence required
  • Root cause analysis for investigations
  • Change management and CAPA execution
  • Cross departmental collaboration

Nice-to-have

  • Strong computer and systems skills
  • Knowledge of aseptic processing
  • Project management abilities
  • Professionalism and resilience
  • Innovation and continuous improvement mindset
  • Teamwork and interpersonal skills

Key Requirements

  • B.A./B.S. Degree in Science or related field OR 5 years pharmaceutical/quality operations experience
  • Experience with pharmaceutical quality management systems
  • Experience writing and executing investigations
  • Knowledge of FDA regulations and cGMPs
  • Ability to work onsite in Rochester, MI

Work Rights

Not specified

Tailored Resume

Cover Letter