Lead Pharmaceutical Quality Control Manager

STAQ Pharma Inc; Denver (CO); On-site; USD 108,000 - 132,000; Full time

Job summary

STAQ Pharma is a 503B Outsourcing Facility located in Denver, Colorado. The QC Manager will lead all Quality Control activities at the site, ensuring compliance with cGMP standards for pharmaceutical manufacturing (503B). A qualified candidate has 5+ years of QC management experience.

The role involves overseeing laboratories, contributing to audits, supporting the stability program, and driving process improvements to deliver safe, high-quality medications for adults and pediatric patients.

Qualifications

• Minimum 5 years of Quality Control managerial experience.
• use of cGMP standards in pharmaceutical manufacturing.
• familiarity with 21 CFR Part 11/21/211 regulations.

Responsibilities

• Develops, manages, and improves Quality Control processes and procedures.
• Oversees laboratory analysis of raw materials, in-process QC, finished goods release testing, and reserve samples.
• Participates in internal/external audits and regulatory inspections.
• Supports the stability program including study management and data trending.
• Identify and implement improvements to operations to enhance quality.

Skills

Quality Control management

cGMP knowledge

Regulatory compliance

Analytical skills

Team leadership

Communication skills

Education

B.S. in Chemistry or Microbiology

Tools

Environmental monitoring program

Laboratory data analysis

Job description

STAQ Pharma is a 503B Outsourcing Facility located in Denver, Colorado. The QC Manager will lead all Quality Control activities at the site, ensuring compliance with cGMP standards for pharmaceutical manufacturing (503B). A qualified candidate has 5+ years of QC management experience.

The role involves overseeing laboratories, contributing to audits, supporting the stability program, and driving process improvements to deliver safe, high-quality medications for adults and pediatric patients.