Are you a Quality Control Specialist with experience in the pharmaceutical industry? Looking for a new permanent role?
My client, a leading pharmaceutical organization in Colorado, is seeking talented Quality Control Manger with strong QA experience to join their ambitious team. This is a fantastic opportunity to grow your career and make a significant impact in a dynamic environment.
Ready for your next challenge?
Core Duties & Responsibilities
• Compiles, analyzes, and reports laboratory data, including department KPIs, team performance metrics, and progress toward departmental and company goals.
• Oversees and updates GxP systems to ensure they comply with established SOPs, policies, cGMPs, and other regulatory requirements.
• Promotes technical and transferable skill development and empowerment of first-line supervisors, holding them accountable for meeting deadlines.
• Communicates priorities related to the sampling, testing, and release of pharmaceutical products, raw materials, and stability samples according to timelines.
• Manages, reviews, updates, and approves new CBT content for the QCC training program.
• Investigates deviations related to QCC Analytical procedures, identifies root causes, assesses impacts, and implements corrective actions. Analyzes trends in deviations and OOS to reduce recurrence.
• Contribute to the development and enhancement of Quality Assurance programs, policies, processes, procedures, and controls to ensure compliance with cGMP and agency guidelines.
• Assists the departmental director in overseeing CMO processes, including document review and approvals.
• Authors, reviews, and approves controlled documents such as SOPs, specifications, test methods, protocols, reports, validation documents, regulatory submissions, and work instructions.
• Engages in third-party and regulatory audits and leads internal audits of QCC.
Knowledge, Skills & Abilities
- Exemplary leadership and supervisory skills, with the ability to coach and mentor staff to develop necessary competencies.
- Extensive knowledge of analytical testing for drug substances and formulations.
- Proficiency with computer systems for sample tracking, laboratory equipment, raw data handling, and storage.
- In-depth understanding of quality systems and regulatory requirements (21 CFR Part 11/210/211), Quality Control, GMPs, GLP.
- Expertise in applying cGMP in a QC chemistry lab to meet US, EU, and ROW standards.
- Experience in conducting investigations, writing deviations, implementing CAPA, and initiating change controls.
- Proven track record in monitoring and improving laboratory KPIs to enhance performance.
- Experience leading QC laboratory audits and inspections.
- Strong independent thinking, organizational, planning, analytical, and problem-solving skills.
- Ability to define, drive, and implement change effectively.
- Proficient in negotiation and collaboration within teams and among team members.
- Proven ability to create and maintain highly functioning teams.
- Skilled in building and maintaining effective relationships and interpersonal/communication skills.
- Ability to coordinate activities to meet both internal and external customer needs.
- Capability to evaluate and allocate resources in the QCC laboratory to ensure adequate support for all processes.