Quality Control Stability Program Manager - Houston, TX - Empower Pharmacy

Position Summary:

At Empower, the Quality Control Stability Program Manager, is a vital part of our mission to produce innovative medications that help people live healthier, happier lives. This role is a cornerstone in maintaining the integrity and safety of our products. You will provide program level oversight to both internal and external lab operations and support critical deliverables. As a key leader in our Quality Control (QC) team, you will have the opportunity to oversee and contribute to the management of a wide range of analytical testing and validation processes, directly impacting the quality of our innovative healthcare solutions.

In this crucial role, you will oversee the QC Stability Program across multiple sites (Houston, New Jersey, etc.) to ensure our products meet current Good Manufacturing Practices (cGMP) specifications per International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) stability. Your technical expertise will play a pivotal role in managing and executing the cGMP stability program and supporting quality assurance in Beyond Use Dating (BUD) as well as expiration dating. You will play a key role in defining the stability approach for new products and technical transfers. You will be instrumental in advancing Empower's mission of producing quality, affordable medications and aligning with our vision of expanding access to healthcare.

Empower offers a dynamic and challenging environment where a dedication to quality and innovation can thrive. If you are detail-oriented with a strong background in stability, laboratory management, are highly motivated and excited about the opportunity to lead a talented team in a forward-thinking organization, this role provides an opportunity to make a meaningful impact. Join us and contribute to a team that is dedicated to making a difference in the health and wellness of the communities we serve.

Empower is dedicated to producing innovative medications that help people live healthier, happier lives and expand access to quality, affordable medication. If you are passionate about making a positive impact, we invite you to apply for the QC Stability Program Manager role. Join us in our mission to enhance the health and well-being of our communities through exceptional stability practices.

Duties and Responsibilities:

• Manages stability program and personnel day-to-day activities to meet critical deliverables and timelines.
• Ensures that the activities of the stability program follow effective Standard Operating Procedures, cGMPs, and ICH guidelines.
• Works closely with internal and outsourced test labs and QC analysts to ensure the timely execution of stability protocols, staging, time point pulls, and summary reports.
• Tracks each stability study to ensure no timepoints are missed. Reviews stability data results within three (3) days for potential trends.
• Responsible for stability protocols, reports, scheduling, sample management, investigations per cGMP requirements.
• Record keeper for all methods developed for Empower Pharmacy’s product line.
• Draft procedures, work instructions, specifications and analytical methods for associated products, and materials.
• Strong collaboration with in-house and outsourced test labs on sample testing, investigation, and test result summaries.
• Coordinate and manage external testing labs to include shipping samples, tracking progress, and managing timelines.
• Obtain quotes and process Purchase Requisitions.
• Ensures stability chambers are maintained in a calibrated/qualified state and meet ICH guidelines.
• Follows the requirements of each stability protocol to maintain all required timelines, including ensuring that stability samples are pulled accurately at each time point, tested, and reported within the designated periods.
• Works to streamline and continuously improve stability operations including, but not limited to, expanding the stability program capabilities to include more storage conditions, to utilize the full storage capacities of existing chambers, and to create/revise tracking and processes for efficiency and cGMP compliance.
• Reports excursions/out of specifications results and conduct investigations as needed.
• Recognizes potential trends and alerts the QC Director about potential issues.
• Attending planned meetings as needed to prioritize the stability program.
• Supports the implementation and operation of QC analytical lab on-site, including technologies such as High-Pressure Liquid Chromatography, Fourier Transform Infrared, Gas Chromatography, pH, osmometer, spectrophotometer, visual appearance, liquid particle counter, refractometer, and polarimeter, etc.
• Assists with establishing product release specifications.
• Supports audits and inspections.
• Provides subject matter expertise, education and guidance on stability matters as needed.
• Partners with site QA and other teams to investigate and resolve issues that require analytical support.
• Leads collaboration with R&D, Manufacturing, Quality Assurance, and other departments to define stability commitments for study design, testing requirements and stability specifications, as appropriate.
• Proactively plans with each site to execute specified batches to place on annual stability study, with no less than 6 weeks of advanced notice.
• Adds all stability reports to Product Binders, housed by the Product Development team.
• Stays current on guidance and regulations set out by the Food and Drug Administration (FDA) and other regulatory bodies to ensure QC activities are compliant and continuously improved on.
• Calculates sample quantities required for testing and the number of samples required per study.
• Monitors and trends stability data to ensure assigned product shelf life is appropriate and justified.
• Prepares accurate stability summary reports for submission to regulatory agencies as required.
• Remains current with regulatory and industry requirements relevant to the stability program.
• 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 accommodation 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 regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

Knowledge and Skills:

• Demonstrated ability to work independently and take initiative on scheduling and meeting deadlines.
• Good working knowledge of FDA and cGMP requirements.
• Thorough understanding of ICH stability guidelines.
• Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, and Outlook.
• Sound understanding of analytical instrumentation and methodologies. For example, chromatography and spectrophotometry, and wet chemistry.
• Operate effectively as a leader and influencer across the enterprise.
• Adhere to safety procedures as outlined in the Chemical Hygiene Plan.
• Utilize Safety Data Sheets for assessing chemical hazards, spill response, and determining personal protective equipment requirements.
• Effectively manage multiple tasks and prioritize work assignments with minimal supervision.
• Demonstrate strong attention to detail.
• Proficient in computer usage.
• Accurately review and complete necessary documentation.
• Strong written and verbal communication skills.
• Highly organized with excellent analytical abilities.
• Capable of managing multiple projects simultaneously.
• Solid understanding of ICH guidelines for stability testing.

 

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:

• Requires a PhD in a scientific discipline such as Biology, Chemistry, Microbiology, or equivalent with a minimum of 2 years of experience in a Quality Control laboratory in an FDA-regulated environment,
  or
• Requires a Master’s degree in a scientific discipline such as Biology, Chemistry, Microbiology or equivalent with a minimum of 4 years of experience in a Quality Control laboratory in an FDA-regulated environment,
  or
• Requires a Bachelor’s degree in scientific discipline such as Biology, Chemistry, Microbiology or equivalent with a minimum of 6 years of experience in a Quality Control laboratory in an FDA-regulated environment.
• Experience with 503B outsourcing facilities preferred.
• Experience with statistical and predictive software/applications.
• Preferred experience in analytical laboratory work within a GMP-regulated environment.

• Certified Safety Professional, Certified Industrial Hygienist, or related certification preferred.

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.
• Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.