Quality Control Manager, Analytical

2 weeks ago

Houston, Texas, United States Empower Pharmacy Full time
Empower Pharmacy: A Visionary Healthcare Company

Empower Pharmacy is a pioneering healthcare company dedicated to delivering high-quality, affordable medication to millions of patients across the nation. Our commitment to excellence is reflected in our position as the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country, serving the functional medicine markets.

Our Core Values

We are driven by three core values: People, Quality, and Service. Our team of dedicated professionals collaborates to break new ground in manufacturing, distribution, and quality control, providing a uniquely integrated approach to healthcare.

Our Mission

We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower Pharmacy is the place for you.

Job Summary

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, overseeing day-to-day lab operations and supporting critical deliverables.

Key Responsibilities
  • Manage analytical laboratory and personnel day-to-day activities to meet critical deliverables and timelines.
  • Support 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.
Requirements

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

Empower Pharmacy offers a dynamic and challenging environment where a dedication to quality and innovation can thrive. Our comprehensive benefits package includes:

  • 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

Empower Pharmacy also offers additional voluntary benefits, including:

  • 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.

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