Senior Associate Quality Complaints

Senior Associate Quality Complaints

Roles & Responsibilities

• Complaint Management:

  Evaluate and ensure triaged product complaint records align with applicable procedures. You will own complaint records with basic investigations and ensure their quality.

• Compliance & Documentation:

  Implement the complaint process per

  SOP

  requirements. You will own or manage the review/approval process flow of controlled documents in

  CDOCS

  , ensuring accuracy and consistency according to templates.

• Investigation & Analysis:

  Apply analytical skills to evaluate complex situations using multiple sources of information. You will also determine if investigations require further action.

• Project Support:

  Support the management of assigned projects or project tasks, including proactive communication, status updates, and tool maintenance, to achieve results within established timelines and quality standards.

Technical Skills

• Experience in a quality and/or manufacturing role within the biotech, medical device, or pharmaceutical industry is preferred.
• Understanding of quality and industry requirements/expectations for a

  Quality Management System (QMS)

  .
• Understanding of applicable manufacturing/testing processes (e.g., API, Drug Substance, Drug Product, Packaging).
• Familiarity with basic project management tools.

Qualifications

• A Master's degree with experience, a Bachelor's degree with relevant experience, or a Diploma with a substantial background in a science field or a related area of study.

Soft Skills

• Problem-Solving:

  Strong analytical skills with the ability to evaluate complex situations and make data-driven decisions.

• Communication:

  Proven ability to communicate clearly and effectively, translating business and stakeholder feedback into accurate and efficient processes.

• Collaboration:

  The ability to operate in a matrixed or team environment, negotiating a position after taking feedback from multiple sources.

• Ownership:

  A demonstrated ability to lead functional teams, consistently deliver high-quality results, and manage your workload to meet timelines.

• Proactiveness:

  A high degree of initiative, with the ability to manage your workload effectively and proactively communicate with stakeholders.