Job Description
QC Supervisor, Pharmaceutical
Location: Northern Colorado
Specialty: Large scale manufacturing
Shift: Monday – Friday, 2:00 pm – 11:00 pm
Full Benefits
Relocation Assistance
Salary: $90-110K; BOE
As the QC Supervisor, you will provide direct leadership to a team of analysts dedicated to the testing and release of pharmaceutical products. You will play a critical role in ensuring manufacturing timelines are met through efficient workload prioritization, technical mentorship, and unwavering adherence to cGMP compliance.
Job Responsibilities
Operational Leadership & Strategy
- Prioritize & Execute: Manage daily laboratory workflows to ensure on-time delivery of all projects, testing, and action items.
- KPI Management: Generate and monitor weekly team performance metrics (KPIs) to drive continuous improvement and transparency.
- Scheduling & Resource Allocation: Partner with the QC Scheduler to balance workloads across sites, ensuring the shortest possible cycle times for product release.
- Financial Stewardship: Monitor departmental spending to remain within established budgetary guidelines.
Compliance & Quality Assurance
- Regulatory Oversight: Ensure all laboratory operations maintain full FDA and cGMP compliance.
- Documentation: Review and approve technical reports, test methods, and specifications. Ensure all Certificates of Analysis (CoA) are issued within 2 business days of test completion.
- Investigations: Lead laboratory investigations (QE/CAPA), supporting 3-day field alert actions and ensuring all deviations are closed within established timelines.
- Audit Readiness: Participate in third-party and regulatory audits, serving as a technical subject matter expert.
People Development & Culture
- Mentorship: Provide active coaching and professional development for direct reports, utilizing career ladders and developmental plans to foster growth.
- Performance Management: Set clear expectations, conduct regular 1-on-1s, and foster an atmosphere of teamwork, respect, and high accountability.
- Training: Maintain the site training matrix, identifying and remediating gaps to ensure a fully cross-trained and competent analytical team.
Knowledge, Skills & Abilities
- Technical Expertise: Expert knowledge in analytical testing of drug substances/formulations (Chemistry or Microbiology) and proficiency with instruments such as HPLC, FTIR, GC, UV-Vis, CCIT, and Endotoxin testing.
- Regulatory Fluent: Thorough understanding of government regulations for drugs and medical devices, including analytical method validation and instrument qualification.
- Systems Proficiency: Skilled in LIMS, raw data handling, and computerized sample tracking systems.
- Problem Solving: Demonstrated ability to lead complex technical investigations and troubleshoot analytical methods.
- Communication: Exceptional interpersonal skills with the ability to escalate issues proactively and communicate effectively across departments.
- Safety: Knowledge of hazardous waste management and chemical spill response procedures.
Education & Experience
- Typically requires a Bachelor’s degree in Chemistry, Microbiology, or a related science.
- Prior experience in a supervisory or lead role within a cGMP laboratory environment is highly preferred.
Disclaimer: This job listing is sourced from LinkedIn and is provided for informational purposes. Apply directly through the employer’s application process. Medical Device Navigator is not affiliated with the hiring company.