Cleanroom Services Team Leader at Leiters Inc

Englewood, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Aug, 26

Salary

33.44

Posted On

27 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

People Leadership, Aseptic Gowning, Sanitization Processes, GMP Compliance, FDA Regulations, CAPA, Deviation Resolution, Microsoft 365, Staffing Management, Process Improvement, Data Collection, Organizational Skills

Industry

Pharmaceutical Manufacturing

Description

This position reports directly to the Sanitization Supervisor. The role is responsible for leading technicians during the cleaning, disinfecting, and sanitizing within the Aseptic Manufacturing Area. The Sanitization Team Leader is responsible for coordinating other activities within the Aseptic Manufacturing Area in support of the production schedule. Why Join Leiters Health? Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team! At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do. * Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement. * Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives. * Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry. * Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing. * Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration. Who We're Looking For: We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today! Essential Functions: This description is intended to be illustrative of the major duties performed by the employee assigned to this position. * Assist Sanitization Supervisor in overseeing employees who are responsible for the cleaning, disinfection, and sanitization of the manufacturing areas as well as the material transfer, waste handling, and supply stocking. * Support Supervisor in the management of daily staffing to meet the daily production schedule. * Provide strong people leadership with a focus on creating/maintaining a positive work environment through effective communication, and accountability. * Ensure training on SOPs and processes remains current. * Ensure compliance with company policies, FDA regulations, safety standards, and GMPs. * Collect data to support production efficiencies including processing time, downtime, and waste. * Perform investigations, CAPA actions, and support deviation resolution for non-conformances in the manufacturing department. * Work with QA to quickly resolve any variance or document errors so that product may be released on time. * Aseptically don sterile gowning and maintain aseptic behaviors while in the cleanroom environment. * Support and participate in sanitization related process improvement projects and initiatives for the manufacturing department. * Adhere to facility safety policies and procedures and proactively identify unsafe conditions. * Train Technicians in sanitization processes and procedures, as needed. * Provide support to the Manufacturing Team as needed and as assigned by the Supervisors to meet the production schedule. * Other duties as assigned. SUPERVISORY RESPONSIBILITIES: * N/A EXPERIENCE AND NECESSARY COMPETENCIES: * Associates degree or equivalent experience required. * 2+ years of sanitization or manufacturing experience in a regulated environment required. 1+ years in a leadership capacity preferred. 1+ years in an aseptic process environment preferred. * Demonstrate exceptional organizational skills with the ability to manage multiple priorities, maintain attention to detail, and ensure timely completion of tasks and projects. * Maintains a strong focus on achieving high-impact outcomes, setting clear goals, and driving performance in alignment with organizational objectives. * Effectively brings cross-functional teams together, fostering a positive and inclusive environment that promotes teamwork, open communication, and shared success. * Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is required. * Proficient written, verbal and oral English communication skills are required. * Proficiency with Microsoft 365 tools including Outlook, Word, 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, for ISO 7 area. Benefits: * Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!) * Flexible Spending & Health Savings Accounts (FSA & HSA) available * Dental & Vision insurance * Employer Paid Life Insurance & Employee Assistance Program * Short Term & Long-Term Disability Insurance * Up to 4% 401K Matching (100% vested on day one!) * Generous Paid Time Off Options – vacation, sick, paid leave and holidays! * $5,250 Annual Tuition Reimbursement after 6 months * $1,000 Referral Bonus Program with no limit * Eligible for annual bonus program    Timeline: We will be accepting applications on an ongoing basis until position is filled.  We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. *Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.

Responsibilities

Lead technicians in the cleaning, disinfecting, and sanitizing of the Aseptic Manufacturing Area to support the production schedule. Oversee daily staffing, ensure SOP compliance, and manage investigations and CAPA actions for non-conformances.