Senior QC Manager, cGMP Pharma Operations

STAQ Pharma; Denver (CO); On-site; USD 120,000 - 180,000; Full time

Job summary

STAQ Pharma, a 503B outsourcing facility in Denver, Colorado, seeks an experienced Quality Control leader to supervise QC processes and ensure adherence to cGMP standards for sterile manufacturing.

You will oversee raw material testing, in-process QC, stability studies, and final product release, while guiding audits, investigations, and CAPAs. Strong regulatory knowledge and team leadership are essential to maintain product quality and patient safety.

Qualifications

• Minimum 5 years of Quality Control managerial experience.
• BS in Chemistry, Microbiology, or equivalent experience.
• Experience with environmental monitoring program for aseptic facility.
• Familiarity with 21CFR Part 11/21/211.
• Strong understanding of cGMP, FDA, USP, ICH regulations.

Responsibilities

• Develops, manages, and improves QC processes to ensure cGMP compliance.
• Oversees laboratory analysis of materials, in-process QC, and final release testing.
• Participates in audits and regulatory inspections.
• Supports stability program and data trending.
• Investigates OOS/OOT and adverse trends within expected timeframes.
• Manages QC samples, documents, and controlled records.
• Coordinate internal lab operations and environmental monitoring.
• Mentor and coordinate QC staff and manage department budget.

Skills

Aseptic techniques

QC management

Regulatory compliance

cGMP familiarity

Environmental monitoring

Analytical skills

Communication

Team leadership

Problem solving

Documentation control

Education

BS in Chemistry or Microbiology

Job description

STAQ Pharma, a 503B outsourcing facility in Denver, Colorado, seeks an experienced Quality Control leader to supervise QC processes and ensure adherence to cGMP standards for sterile manufacturing.

You will oversee raw material testing, in-process QC, stability studies, and final product release, while guiding audits, investigations, and CAPAs. Strong regulatory knowledge and team leadership are essential to maintain product quality and patient safety.