quality control in libertyville

posted
job type
permanent
salary
US$ 100,000 per year
apply now

job details

posted
location
libertyville, illinois
job category
Biotechnology & Pharmaceutical
job type
permanent
salary
US$ 100,000 per year
reference number
24694
apply now

job description

Senior Manager of QA, External Manufacturing

Northern IL Suburbs

Salary Range: $100K - $115K

  • Supports third party operations for clinical trial and commercial manufacturing supply
  • Works across multiple functions to assure the supply of quality products to patients through the review of batch record documentation and investigates issues including customer and vendor complaints
  • Supports the transition of activities relating to the tech transfer of products
  • Escalates issues / challenges as needed to manager
  • Other duties as assigned

Qualifications:

  • Bachelor's degree required in Chemistry, Biochemistry or similar technical disciplines
  • Minimum 7 years' experience in a QA role working in a pharmaceutical environment with knowledge of cGXP and quality management systems
  • Minimum 5 years' experience in managing complex projects
  • Minimum 3 years' experience in QA support of manufacturing of recombinant proteins or plasmid DNA
  • Minimum 3 years' experience in an External Manufacturing/CMO compliance role
  • High level of accuracy and attention to detail
  • Good written and verbal communication skills with the ability to convey information clearly and accurately
  • Knowledge of clinical trials and commercial manufacturing
  • Experience managing customer complaints
  • Good problem solving skills
  • Travel Requirements: Domestic and international travel required (25%)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.