Full-Time

Quality Control Manager

Posted on 5/16/2024

Azurity Pharmaceuticals

Azurity Pharmaceuticals

201-500 employees

Pharmaceuticals for diverse medical conditions


Mid, Senior

Burlington, MA, USA

Requirements
  • Knowledge of CFR 210, 211, USP, and FDA/ICH guidance
  • Understand procedures and policies, Good Documentation Practices and Good Laboratory Practices
  • Minimum BSc. in Life Sciences, Chemistry or Biology preferred
  • Minimum 5-7 years related experience in a CGMP QC lab of pharmaceutical industry
Responsibilities
  • Provide leadership in the QC organization to ensure compliance, drive improvements and achieve schedule adherence
  • Work with cross-functional teams to align testing schedules to meet production needs
  • Manage applicable deviations, CAPAs and investigations
  • Manage Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations
  • Stays current on publications released by USP, FDA and other pertinent regulating bodies to ensure the Quality Control Laboratories are compliant and continuously improved upon
  • Participates in the hiring on laboratory staff
  • Review and approve test data as needed
  • Attends project meetings and prepares project updates
  • Maintain a safe, clean, well-organized, and efficient laboratory work environment
  • Represent the QC Director in his/her absence.
  • Additional responsibilities as assigned by the QC Director

Azurity Pharmaceuticals

Azurity Pharmaceuticals

View

Azurity Pharmaceuticals specializes in providing innovative, high-quality medicines, including dose-form innovations for cardiovascular, central nervous system, endocrine, gastro-intestinal, anti-infective, and oncology conditions, benefiting millions of people.

Company Stage

Series B

Total Funding

$182.2M

Headquarters

Woburn, Massachusetts

Founded

2000

Growth & Insights
Headcount

6 month growth

-2%

1 year growth

10%

2 year growth

65%