Environmental Monitoring Analyst II

Position Summary

As an Environmental Monitoring (EM) Analyst II, you play a key role in leading advanced monitoring and contamination control activities that safeguard the integrity of our cleanroom operations. You will mentor and support junior team members while ensuring compliance with Food and Drug Administration (FDA) regulations, United States Pharmacopeia (USP) standards, and current Good Manufacturing Practices (cGMP). This role empowers you to drive quality and innovation at Empower Pharmacy, directly contributing to our mission of providing patients with safe, effective, and affordable medications.

Duties and Responsibilities

• Leads advanced environmental monitoring activities, analyzing trends in viable and non-viable data to identify risks and prevent contamination events.
• Supports investigations into deviations and out-of-specification results, partnering with Quality Assurance (QA) and Quality Control (QC) teams to determine root causes and implement corrective actions.
• Assists in the development, review, and enhancement of Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure enhanced contamination control and adherence to regulatory requirements and industry best practices.
• Mentors and trains Environmental Monitoring (EM) Analysts I team members to build knowledge, consistency, and professional development.
• Ensures the accurate and timely maintenance of records, logs, and reports to facilitate successful regulatory inspections, audits, and compliance activities.
  
  

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

Knowledge and Skills

• Strong collaboration skills with the ability to coach others and communicate effectively across departments.
• Proficiency in environmental monitoring methods, data trending, Standard Operating Procedures (SOPs), and Work Instructions (WIs); experience with Enterprise Resource Planning (ERP) systems and Microsoft Office applications preferred.
  
  

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
  
  

Values

• People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
• Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
• Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
• Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.
  
  

Experience And Qualifications

• A minimum of 2 years of experience in pharmaceutical, biotechnology, or healthcare manufacturing environments with exposure to cleanroom practices or quality systems.
• Requires a Bachelor’s degree in Life Sciences or related experience.
• Current Good Manufacturing Practices (cGMP) certification preferred; aseptic technique certification preferred; International Organization for Standardization (ISO) training preferred; Environmental Health and Safety (EHS) training preferred.
  
  

Benefits

We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/