Demo

QA Specialist (CAPA/Lean Six Sigma) (Pharma/Medical Device)

Systems Ally
North Chicago, IL Full Time
POSTED ON 4/3/2025
AVAILABLE BEFORE 6/2/2025

Description:

  • Engages cross functionally to investigate and document compliance events, ensuring timely resolution to enable program timelines.
  • Works with Databases and electronic systems.
  • Follows through with business partners to receive investigation results, actions planned, and closure of actions by requesting and reviewing objective evidence.
  • Collects relevant monthly and quarterly metrics.

Skills:

  • Pharmaceutical experience required.
  • Experience in CAPA / Quality Assurance Preferred.

Education:

  • Bachelor’s degree or equivalent plus 4 years of related work experience or equivalent combination.

Years Experience:

  • 4

NOTES:

What hours and days will this person be working?

  • M-F, 8-4:30 (hours can be flexed)

What are the top 5 skills/requirements this person is required have?

  • Required Skill 1: Effective Communicator. Strong technical writing skills; Clear, concise and effective in written communication.
  • Required Skill 2: Self-starter, takes initiative and owns the task
  • Required Skill 3: Organized
  • Required Skill 4: Ability to lead a diverse team and drive results
  • Required Skill 5: Adept at learning and utilizing multiple electronic systems. Proficient in MS Office Suites.

What years of experience is required?

  • Minimum 2yrs, 4 preferred.

What level of education and/or certification is required?

  • Bachelors

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

  • Previous experience in CAPA, Lean Six Sigma, Quality Assurance or program management,

What positions/background experience do you feel are successful in this role

  • Demonstrated experience in technical writing, managing program timelines, leading diverse teams, experience in CAPA, Lean Six Sigma, Quality Assurance or program management,

Job Type: Contract

Pay: $38.00 - $40.00 per hour

Expected hours: 40 per week

Benefits:

  • Health insurance

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Education:

  • Bachelor's (Preferred)

Experience:

  • CAPA: 3 years (Preferred)
  • Quality Assurance: 3 years (Preferred)
  • lean six sigma: 3 years (Preferred)
  • technical writing: 3 years (Preferred)
  • Pharma or biotech or medical device industry: 3 years (Preferred)

Ability to Commute:

  • North Chicago, IL 60064 (Required)

Work Location: In person

Salary : $38 - $40

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