Quality Control Analyst II, Environmental Monitoring (EM) - Empower Pharmacy

Position Summary:

At Empower, we’re dedicated to pioneering innovations in health and wellness medications, and we're searching for a talented Quality Control Analyst II, Environmental Monitoring (EM) to join our team. This position is pivotal, as it ensures that our high-quality standards are maintained and our mission to produce innovative medications is fulfilled. As a Quality Control Analyst II- EM, you will be instrumental in maintaining our laboratories' environmental integrity through routine monitoring and precise documentation, adhering to our Good Documentation Practices (GDP) standards.

 

You will serve as a subject matter expert, guiding and training junior team members in gowning qualification and environmental monitoring procedures, demonstrating our dedication to continuous learning and growth. Your role will also encompass performing critical process interventions for viable and non-viable Environmental Monitoring, as well as assisting in program setup and implementation, showcasing your adaptability and problem-solving skills.

 

In this position, you'll be at the forefront of our quality control efforts, supporting change controls, deviations, and investigations, and contributing to corrective and preventive actions (CAPAs). Your expertise will also be crucial in preparing our laboratory for internal and external inspections, ensuring we meet the highest industry standards.

 

At Empower, we are on a mission to help people live healthier, happier lives through quality, affordable medications. If you're passionate about ensuring the highest standards of quality and ready to join a team that values innovation, collaboration, and a commitment to improving lives, Empower is the place where you can truly make a difference.

Duties and Responsibilities:

• Independently performs routine environmental monitoring and documentation per good documentation practices (GDP) standards.
• Conducts and communicates results of lab investigations when test results fall outside of pre-established specifications (Out-of-Specifications (OOS)).
• Acts as subject matter expert and provides training to junior personnel on gowning qualification program and on environmental/personnel monitoring procedures, per GMP requirements.
• Performs critical process interventions for viable and non-viable Environmental Monitoring (EM) as needed.
• Assists with EM program setup and implementation.
• Assists in change controls, deviations, Quality Control investigations, and CAPAs.
• Supports sample and material management in the EM laboratory.
• Identifies and supports resolution of technical problems.
• Assists in preparing for internal and external inspections to ensure microbiology laboratory is ready at all times.
• Ability to create and revise lab associated documents like testing procedures, testing forms, SOPS.
• Performs other duties as assigned.

 

To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

 

While performing the responsibilities of the job, the employee is required to gown up to access controlled areas and spend a significant amount of the workday standing up and in said controlled areas. The employee is also 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. Vision abilities required by this job include close vision.

Knowledge and Skills:

• Strong time management skills.
• Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook.

 

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 other accountable to meet commitment.
• 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.

Experience and Qualifications:

• Bachelor’s degree in microbiology, earth science, or other related field or equivalent experience with at least 1 year of experience in a QC laboratory, or
• Associate’s degree in microbiology, earth science, or other related field or experience with 2-4 years of experience in a QC laboratory required.
• Previous experience using GMP quality systems a plus.

Benefits:

• No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden
• Onsite Health & Wellness – IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels
• Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family
• Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family
• Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off
• Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions
• Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance
• FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA)
• 401K Dollar-for-Dollar Up to 3%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 3%
• Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time
• Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options
• Rewards & Recognition Program: Your hard work doesn't go unnoticed – enjoy rewards and recognition beyond your paycheck

 

Additional Voluntary Benefits

• Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury
• Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays
• Critical Illness: Protect your finances from the expenses of a serious health issue
• Short-Term Disability: Protect your income during illness or injury with short-term disability coverage
• Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage
• Legal Services: Access professional legal assistance to address concerns confidently
• Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit
• Pet Insurance: Care for your furry family members with our pet insurance coverage
• Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being