Manager, Quality Control

Confidential - Buffalo Grove, IL

Full-time$80,000 - $100,000 a year
EducationSkills

Job Title: Manager, Quality Control

Summary: The Manager, Quality Control will be responsible for

  • Day-to-day activities of the Quality Control department.
  • Manage the inspection and testing of products to ensure adherence to established quality standards.
  • Planning, coordinating and direct control testing & release of products while promoting and maintaining Company objectives and Quality Policies.

Key Responsibilities & Duties:

  • Managing, and scheduling of day-to-day activities for timely release of products
  • Ensuring that all QC testing is conducted according to approved SOPs
  • Approving, reviewing and improving QC SOPs
  • Produce reports regarding nonconformance of products or processes, daily production quality, root cause analyses, or quality trends
  • Ensure corporate Quality objectives are met and documented (ISO 13485, CMDR and 21CFR 820)
  • Approving, designing & reviewing of investigations, OOS and NCMRs
  • Conducts presentations of technical information concerning specific quality issues, scheduled or projects to production management or staff
  • Provides technical assistance and training to QC personnel
  • Communicate quality control information to all relevant organizational departments, outside vendors, and contractors
  • Ensures maintenance of QC equipment
  • Participating and/or leading departmental meetings
  • Participating in cross departmental core teams/review committees
  • Developing, budgeting, adherence and managing QC department plans
  • Hires, trains, motivates, leads, develops and evaluates staff

Education and Experience:

  • Bachelors of Science degree in Life Sciences, Chemistry, or Biosciences field. Advanced degree is preferred.
  • Molecular assay experience preferred
  • Minimum 3 years relevant managerial experience

Training, Skills and Certifications/Licenses:

  • Thorough knowledge of cGMP regulations (21 CFR 820, CMDR and ISO 13485) and thorough knowledge of their impact on Quality Control
  • Thorough knowledge of nucleic acid molecular techniques and enzyme reactions
  • Solid written, verbal & communication skills
  • Strong leadership skills
  • Proficiency in Microsoft Office
  • Detail oriented
  • Strong Chemistry background preferred
  • Excellent Project Management skills

Work Conditions:

  • Must work onsite at office
  • Travel may be required at least 20% of the time
  • Physical Demands: All positions require standing, stooping, bending, climbing, sitting, kneeling, and lifting at least 10 lbs. Additional physical requirements are listed below:
  • Pounds lifted (up to 20lbs)
  • Vision (Color) on the job is required occasionally

Job Type: Full-time

Salary: $80,000.00 to $100,000.00 /year

Experience:

  • relevant: 3 years (Required)
  • Quality Assurance: 3 years (Required)