Supervisor Operations

Job Title:

QA Specialist

06 Months

Des Plaines, IL 60016 (Onsite)

• Responsible for maintaining a strong collaborative partnership with cross‑functional team members that facilitates organizational success for assuring high product quality and meeting business needs.

• Works with a cross functional team to review qualification and validation documents which meet regulatory requirements.
• Supports the complete qualification and validation process to implement new manufacturing FUE and automation, process, test method validations in support of a manufacturing expansion, especially in HPLC synthesis, purification and testing.
• Supports on‑market change control projects.

• Bachelor's degree in Life Science;
  Engineering; or closely related discipline is required OR relevant combination of education or experience.
• At least 5 years work experience in Quality or related field experience;
  Has a history of completing successful projects and driving positive compliance outcomes.

• Bachelor's or master's degree in one of the following Engineering disciplines:
  Chemical, Electrical, Bio‑medical, or Mechanical; 5+ years of relative professional work experience in Medical Device Quality/Pharmaceutical or in a regulated industry.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Strong technical writing skills;
  Polished verbal and written communication skills.