Analytical Technician
Leiters Inc
Summary
The Analytical Technician reports to the Analytical and Label Manager and is responsible for performing quality activities and maintaining a quality environment in a sterile pharmaceutical manufacturing facility. The candidate should have an understanding of laboratory environments, production environments and cGMP requirements. The position requires an individual who works independently and in a team environment, with attention to detail, and maintains communication with other functional areas and sites.
Job description
Essential Functions
- Perform analytical techniques such as pH measurement, Osmolality analysis, Filter Integrity (FIT) testing etc.
- Review analyses carried out through in-house labs and file data.
- Support investigations when OOS, deviations or errors occur.
- Participate in reviews of process performance, product quality, and advocating continual improvement.
- Comprehend and execute SOPs, forms, operational GMP training, and quality activities.
- Print and issue labels to the manufacturing process.
- Perform AQL (Acceptable Quality Level) review.
- Other duties as assigned.
Experience and Necessary Competencies
- High school diploma or GED required.
- 0-2 years of a quality position at a cGMP facility.
- Sterile injectable product preferred. Food, cosmetic or pharmaceutical will be considered.
- Ability to communicate with multiple departments.
- Ability to adapt to changing priorities and circumstances.
- Able to consistently record critical data correctly and legibly.
- 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, stoop, bend, climb or sit for extended periods of time.
- Ability to work in small compartments at floor level.
- Ability to lift, push and pull up to 50 pounds periodically.
- Ability to obtain and maintain a sterile gowning qualification.
Requirements
- High school diploma or GED required
- 0-2 years of a quality position at a cGMP facility
- Proficient written, verbal and oral English communication skills
- Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel
- Ability to communicate with multiple departments
- Ability to adapt to changing priorities and circumstances
- Able to consistently record critical data correctly and legibly
- Ability to stand, stoop, bend, climb or sit for extended periods of time
- Ability to work in small compartments at floor level
- Ability to lift, push and pull up to 50 pounds periodically
- Ability to obtain and maintain a sterile gowning qualification
Benefits
- Healthcare coverage
- FSA & HSA
- Dental & Vision insurance
- Employer Paid Life Insurance
- Employee Assistance Program
- Short & Long-Term Disability
- 401(k) Matching
- Paid Time Off
- Tuition Reimbursement
- Referral Bonus Program
- 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.