Quality Control Manager, Analytical - Empower Pharmacy

Position Summary:

At Empower, the Analytical Quality Control 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'll oversee day-to-day lab operations and support critical deliverables. As a key leader in our Quality Control team, you will have the opportunity to oversee and contribute to 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 routine Quality Control release testing of raw materials and finished product. Additionally, this role is responsible for analytical method development and validation, and the stability program to ensure our products meet cGMP specifications for identity, purity, strength, and safety. Your technical expertise will play a pivotal role in developing raw material and product specifications, executing the cGMP stability program, and supporting quality assurance in product release. You'll be instrumental in advancing Empower's vision of producing quality, affordable medications.

 

Empower offers a dynamic and challenging environment where a dedication to quality and innovation can thrive. If you're detail-oriented with a strong background in laboratory management, highly motivated and are 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.

Duties and Responsibilities:

• Manages analytical laboratory and personnel day-to-day activities to meet critical deliverables and timelines.
• Supports implementation and operation of QC analytical lab on-site, including technologies such as HPLC, FTIR, GC, pH, osmometer, spectrophotometer, visual appearance, liquid particle counter, refractometer, and polarimeter,
• Responsible for method development/transfer and validation on-site, including generation of required protocols/reports per GMP requirements.
• Provides technical expertise in the development of raw materials and finished product specifications, as well as support QA in COA issuance and product release.
• Provides technical expertise and supports execution of cGMP stability program (sample management. protocols, reports, etc.).
• Executes deviation and out of specification investigations.
• Maintains strong collaboration with outsourced test labs on sample testing, investigation, and test result summaries.
• Drafts procedures, work instructions, specifications and analytical methods for associated products and materials.
• Supports the design of a QC lab and manages the procurement and placement of new lab equipment including equipment and software IQ/OQ and PQ.
• Supports audits and inspections.
• Ensures products meet cGMP CQA specifications for identity, purity, strength, and safety.
• Reviews executed analytical procedures and provides guidance/training to junior personnel as needed.
• Works with QA and other teams to investigate and resolve issues that require analytical support.
• Stays current on guidance and regulations set out by FDA and other regulatory bodies to ensure QC activities are compliant and continuously improved on.
• 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 often required to remain in a stationary position for a significant amount of the work day 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:

• Demonstrated ability to work independently and take initiative on scheduling and meeting deadlines.
• Good working knowledge of FDA cGMP requirements.
• 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:

• Requires a PhD in a scientific discipline such as Biology, Chemistry, Microbiology, or equivalent and 2-3 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 and 3-6 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 and 7-10 years of experience in a Quality Control laboratory in an FDA-regulated environment.

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.