Website Empower Pharmacy
Empower Pharmacy
Company : Empower Pharmacy
Position Summary:
The Microbiologist II ensures product safety and quality by conducting microbiological testing, developing methods, and adhering to current Good Manufacturing Practices (cGMP). This role supports process improvements and advances Empower’s mission to expand access to affordable, innovative medications.
Duties and Responsibilities:
- Conducts and reviews microbiological testing of raw materials, finished products, and environmental samples, including microbial enumeration, identification, and antimicrobial effectiveness testing.
- Performs laboratory investigations, including root cause analysis for Out of Specification results, and implements corrective actions to address findings.
- Develops and validates microbiological test methods in compliance with regulatory standards, maintains detailed records, and prepares technical reports and presentations.
- Adheres to laboratory protocols, safety guidelines, and regulatory standards, including cGMP, Good Laboratory Documentation Practices, and United States Pharmacopeia (USP) regulations for sterile and nonsterile labs.
- Supports microbiology projects, drives process improvements, and contributes insights to research discussions and project meetings to enhance laboratory efficiency and innovation.
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 analytical and problem-solving skills with the ability to work collaboratively, communicate technical findings effectively, and ensure compliance with regulatory and safety standards.
- Proficiency in microbiological testing methods, method development, and validation procedures, including bacterial endotoxin testing, sterility, and microbial limit testing, with experience in compendial testing, USP, Food and Drug Administration, and cGMP requirements.
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:
- Minimum 3 years of microbiology laboratory experience in pharmaceutical or compounding environments required.
- Bachelor's degree in Microbiology, Biology, Biochemistry, or related field required.
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: (url removed)