Analytical Lead
Leiters Inc
Summary
The Analytical Lead reports directly to the Quality Manager. The role is responsible for the day-to-day support and leadership of quality control activities.
Job description
Essential Functions
- Daily leadership of employees who are responsible for Analytical activities.
- Provide a positive work environment through effective communication.
- Ensure all SOPs are current, and training on SOPs and processes remains current.
- Analyze Analytical efficiencies, downtime, and waste.
- Lead improvement initiatives.
- Participate in finding a “better way”.
- Lead problem solving activities and root cause analysis for department variances or deviations.
- Write investigations and CAPA actions for non-conformances in the department.
- Work with cross-functional teams to conduct investigations.
- Other duties as assigned.
Experience and Necessary Skills
- 2+ years of Quality experience required; 1+ years in a leadership capacity preferred.
- Strong problem solving such as Six Sigma and Lean training, Green Belt or Black Belt preferred.
- Demonstrated written and oral communications skills including strong presentation skills.
- Excellent organizational skills.
- Strong results orientation.
- Good understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus!
- Proficient written, verbal and oral English communication skills are required.
- Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.
Physical Requirements
- Ability to stand or sit for extended periods of time.
- Ability to lift, push and pull up to 50 pounds periodically.
- Ability to maintain a gowning qualification, if applicable.
Requirements
- 2+ years of Quality experience required
- 1+ years in a leadership capacity preferred
- Strong problem solving such as Six Sigma and Lean training, Green Belt or Black Belt preferred
- Demonstrated written and oral communications skills including strong presentation skills
- Excellent organizational skills
- Strong results orientation
- Good understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus
- Proficient written, verbal and oral English communication skills are required
- Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel
Benefits
- Healthcare Coverage
- Flexible Spending Account
- Health Savings Account
- Dental Insurance
- Vision Insurance
- Employer-Paid Life Insurance
- Employee Assistance Program
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- 401(k) Matching
- Paid Time Off
- Tuition Reimbursement
- Referral Bonus
- Annual Bonus Program
Company overview
Leiters Health, operating as Leiters Inc, is a leading FDA-registered 503B outsourcing provider specializing in high-quality compounded sterile preparations and pharmacy services. Founded in 1926 and headquartered in Englewood, Colorado, the company has evolved from a small family pharmacy into a sophisticated pharmaceutical manufacturing organization serving hospitals, surgery centers, clinics, and physician offices nationwide. Leiters operates state-of-the-art facilities that produce ready-to-administer compounded medications, including pre-filled IV bags, syringes, and concentrated vials for critical care, ophthalmology, anesthesia, and pain management applications. The company's expertise spans sterile pharmaceutical manufacturing, repackaging, and compounding, with a strong focus on quality, consistency, and regulatory compliance under Current Good Manufacturing Practices (cGMP). Leiters plays a vital role in addressing drug shortages and supporting healthcare providers with reliable, high-quality pharmaceutical solutions that enhance patient safety and streamline clinical workflows.