Principal Quality Investigator

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Job description

Position Summary:
The Director of Quality Operations at Empower Pharmacy plays a pivotal role in ensuring the highest standards of quality and compliance across our 503A and 503B operations. This position is integral to maintaining our commitment to excellence in product safety, regulatory adherence, and operational efficiency. By leading critical quality investigations and implementing robust corrective and preventive actions, this role directly aligns with our core values of people, service, quality, and innovation.

In this leadership position, you will manage ongoing investigations for our 503B operations, ensuring they are closed promptly and effectively. Your ability to analyze complex issues, lead cross-functional teams, and present detailed trending analyses to leadership will be crucial in driving continuous improvement and maintaining regulatory compliance. As a subject matter expert, you will guide the quality operations team in identifying root causes, determining corrective actions, and assessing product impacts, ensuring that our processes meet the highest standards.

Additionally, you will be responsible for developing and executing training programs to certify employees in writing effective investigations, further strengthening our quality operations. Your expertise will be vital in aligning investigation priorities across multiple functions and in communicating these priorities during regulatory inspections. By overseeing the execution of Corrective and Preventive Actions (CAPAs) and ensuring compliance with Standard Operating Procedures (SOPs), you will play a key role in safeguarding the quality of our products and processes.

We invite you to join our team and contribute to our mission of producing innovative medications that help people live healthier, happier lives. If you are passionate about quality operations and are excited about the opportunity to make a significant impact through your leadership, we encourage you to apply and be a part of our journey to expand access to quality, affordable medication.

Duties and Responsibilities:
Manages all on-going investigations for 503B to ensure timely closure.

Analyzes, prepares, and presents trending analysis to middle, senior and executive leadership.

Leads cross-functional teams to resolve complex investigations and those with significant potential impact to the organization.

Leads, develops, and oversees the execution of CAPAs as necessary for proper investigation remediation.

Develops, implements, and executes a training program to teach and certify employees to write effective investigations.

Aligns and communicates investigation priorities across multiple functions.

Reviews and approves investigations as the quality representative.

Understands and presents investigations and investigation trending during regulatory inspections.

Acts as the subject matter expert for quality operations for investigations pertaining to analyzing and determining root cause analysis, identifying corrective and preventative actions, determining product impact assessment.

Acts as a senior consultant to quality leadership team.

Supports department and company initiatives to ensure quality assurance and adherence to United States Pharmacopeia (USP) Guidelines, Food and Drug Administration regulations, and Boards of Pharmacy standards for our 503A locations, and current good manufacturing practices (cGMP) standards for our 503B locations. This oversight includes warehouse operations, manufacturing processes, inspection, labeling and packaging, batch record review, batch disposition, and product distribution.

Ensures company is following established SOPs.

Ensures all work is performed and documented in a timely manner and according to approved SOP and in general compliance with cGMP.

Assists and collaborates with the Quality Operations leadership.

Demonstrates an elevated level of discretion in the timely identification and resolution of events potentially impacting the quality of products and processes.

Evaluates and provides input based on technical expertise and knowledge of current processes.

Oversees training of department employees on new or revised processes as they occur.

Follows and encourages safety and appropriate regulatory guidelines.

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 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 occasionally 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:
Excellent attention to detail.

Basic PC skills including MS Word and Excel.

Ability to manage multiple projects concurrently, time management skills.

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.

Experience and Qualifications:
Bachelor's degree in science or related field.

Minimum 5 years of experience in Quality Assurance/Control Operations or a related field in the healthcare industry required.

Minimum of 3 years experience working with pharmaceutical investigations, conducting root cause analysis and technical writing.

Experience with 503A compounding regulations, 503B outsourcing regulations, USP 795, USP 797, and USP 800 preferred.

Previous experience in technical writing and conducting root cause analysis.

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 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.

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.
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