Sterility Assurance Specialist

5 days ago


Sugar Land, Texas, United States QuVa Pharma Full time
About the Role

We are seeking a highly skilled Sterility Assurance Specialist to join our team at QuVa Pharma. As a key member of our quality assurance team, you will play a vital role in ensuring the highest quality and safety standards of our pharmaceutical products.

Key Responsibilities
  • Ensure company compliance to QuVa Pharma's Standard Operating Procedures (SOPs) and Quality Management System (QMS)
  • Schedule and proctor media fills, observing technicians in compounding and routine clean room activities
  • Review Environmental/Personnel monitoring data to identify any potential trends
  • Provide qualification support for personnel on appropriate gowning techniques, aseptic techniques, and execution of Compounder and MQA EM Specialist Competency Assessments
  • Perform reading of media aseptic process simulations and Environmental/Personnel Monitoring (EM/PM) plates and accounting of all units
  • Perform EM/PM sampling as needed; maintain EM/PM records
  • Maintain Media Fill and Gown Qualification/Requalification records
  • Provide support for sterility investigations, including EM/PM excursions and review of deviations and investigations
  • Assist in the generation of Sterility Assurance reports and documents
  • Follow all regulatory guidelines, cGMP guidelines, and aseptic techniques as required by the job function
  • Work in accordance with area supervision to provide quality assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs)
  • Support department supervision in oversight and prioritization of day-to-day responsibilities
  • Ensure all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMP
  • Demonstrate a high level of discretion in the timely identification and resolution of events potentially impacting the Quality of products and processes
  • Evaluate batches/product for compliance with defined specifications
Requirements
  • A High School diploma or equivalent
  • Able to successfully complete a drug and background check
  • At least 2 years' experience in Quality Assurance, Microbiology, Sterile Compounding in pharmaceutical manufacturing
  • Previous training and experience in environmental monitoring and sampling
  • Thorough understanding of 21CFR Part 211 cGMP requirements for sterile drug products with emphasis on 2004 Guidance for Sterile Drug Products produced by Aseptic Processing
  • Strong Microsoft Word and Excel skills
  • Must be currently authorized to work in the United States on a full-time basis; QuVa will not sponsor applicants for work visas
Preferred Qualifications
  • Bachelor's Degree in life science or related field (preferably Microbiology)
About QuVa Pharma

QuVa Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care. We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide.

As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality.

As part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery.

QuVa is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment.



  • Sugar Land, Texas, United States Houston Methodist Sugar Land Hospital Full time

    Job SummaryWe are seeking a highly skilled and experienced Sterile Processing Supervisor to join our team at Houston Methodist Sugar Land Hospital. As a key member of our Sterile Processing department, you will be responsible for overseeing the day-to-day operations of our Sterile Processing unit, ensuring the highest level of quality and efficiency in the...


  • Sugar Land, Texas, United States Houston Methodist Sugar Land Hospital Full time

    About the RoleWe are seeking a highly skilled and experienced Sterile Processing Supervisor to join our team at Houston Methodist Sugar Land Hospital. As a key member of our Sterile Processing department, you will be responsible for ensuring the efficient and effective processing of medical instruments and equipment.Key ResponsibilitiesOversee the daily...

  • Surgical Specialist

    1 week ago


    Sugar Land, Texas, United States Unavailable Full time

    Job SummarySt. Lukes Health–Sugar Land Hospital is seeking a highly skilled Surgical Specialist to join our team. As a Surgical Specialist, you will be responsible for providing exceptional patient care and support in the operating room.Key Responsibilities**Surgical Equipment Expertise**• Possesses superior knowledge of various surgical equipment and...


  • Sugar Land, Texas, United States Healix Infusion Therapy Full time

    About the RoleWe are seeking a highly skilled and experienced Certified Pharmacy Technician to join our team at Healix Infusion Therapy. As a National Coverage Specialist (CPhT), you will play a critical role in ensuring the delivery of high-quality patient care in our pharmacy facilities throughout the US.Key ResponsibilitiesTravel to various Office...


  • Sugar Land, Texas, United States Froedtert Health Full time

    Location:Froedtert HealthPosition:Environmental Services SpecialistJob Summary:The Environmental Services Specialist is essential in ensuring that every patient, visitor, and staff member experiences a clean, safe, and sanitized environment conducive to healing and outstanding patient care. This role involves planning daily tasks with necessary supplies,...

  • Skincare Specialist

    3 weeks ago


    Sugar Land, Texas, United States Hire Life Recruiting and Consulting Full time

    About Us: Hire Life Recruiting and Consulting is excited to announce an opportunity for a skilled and passionate Skincare Specialist to join our dynamic team. We are looking for an individual who is dedicated to providing exceptional skincare services and has a strong desire to build and maintain a loyal clientele. This role offers a lucrative...


  • Sugar Land, Texas, United States Army Installation Management Command Full time

    Applies advanced IT principles, concepts, methods, standards, and practices to plan and carry out difficult and complex assignments and develop new methods, approaches, and procedures. Develops and interprets policies, procedures, and strategies governing the planning and delivery of IT services throughout the organization.Provides expert technical advice,...


  • Sugar Land, Texas, United States Unavailable Full time

    Position OverviewAt Unavailable, we are committed to providing cutting-edge technology and exceptional medical services. Our team is dedicated to delivering high-quality care across various specialties, including cardiac health and advanced surgical procedures. We pride ourselves on creating a supportive environment for both our patients and staff.Key...


  • Sugar Land, Texas, United States Hire Life Recruiting and Consulting Full time

    About Karishma Med Spa & TrainingWe are seeking a highly skilled and dedicated Aesthetician to join our team as a Skincare Specialist. This is a high-paying commission-based opportunity for an experienced Aesthetician looking to build their clientele and deliver exceptional customer service.Key Responsibilities:Skincare Consultations:Conduct thorough...

  • Endoscopy Specialist

    2 weeks ago


    Sugar Land, Texas, United States INFOSAGE SYSTEMS Full time

    Job SummaryWe are seeking a highly skilled Endoscopy Technician to join our team at Infosage Systems. As an Endoscopy Technician, you will play a critical role in assisting healthcare professionals during endoscopic procedures.Key ResponsibilitiesPrepare and set up the endoscopy room, ensuring all necessary equipment and supplies are available and in working...


  • Sugar Land, Texas, United States Catholic Health Initiatives Full time

    Position OverviewCatholic Health Initiatives is dedicated to providing advanced medical services and innovative treatments to our community. Our organization encompasses a wide range of healthcare services, ensuring comprehensive care for our patients. We pride ourselves on our commitment to excellence in healthcare delivery, with a focus on creating a...


  • Sugar Land, Texas, United States Mercedes-Benz Full time

    Certified Automotive Specialist - Mercedes-BenzAt Mercedes-Benz, we are committed to providing exceptional service and quality to our customers. We are currently seeking experienced Automotive Technicians to join our team in a state-of-the-art facility that prioritizes both employee satisfaction and customer care.What We Offer:Competitive compensation with a...


  • Sugar Land, Texas, United States ABM Industries Full time

    About the RoleWe are seeking a highly skilled and experienced Director to lead our Talent Acquisition Process Improvement efforts. As a key member of our team, you will be responsible for driving process reengineering and continuous improvement initiatives to optimize recruitment performances, ensure compliance, and quality assurance.Key...


  • Sugar Land, Texas, United States ABM Industries Full time

    About the RoleWe are seeking a highly skilled and experienced Director to lead our Talent Acquisition Process Improvement efforts. As a key member of our team, you will be responsible for driving process reengineering and continuous improvement initiatives to optimize recruitment performances, ensure compliance, and quality assurance.Key...


  • Sugar Land, Texas, United States Houston Methodist Full time

    Position OverviewThe Surgical Services Nursing Assistant plays a crucial role in the perioperative environment, utilizing foundational knowledge and skills to effectively communicate and execute delegated tasks under the guidance of a licensed nurse. This role is integral in preparing both patients and the surgical setting prior to procedures, ensuring a...

  • MRI Technologist II

    5 days ago


    Sugar Land, Texas, United States Houston Methodist Sugar Land Hospital Full time

    Job SummaryWe are seeking a highly skilled MRI Technologist II to join our team at Houston Methodist Sugar Land Hospital. As a key member of our diagnostic imaging department, you will be responsible for performing a variety of routine to complex diagnostic MRI procedures, ensuring exceptional patient care and adhering to strict safety and quality...


  • Sugar Land, Texas, United States Fuel Powersports Full time

    Position OverviewFuel Powersports is seeking a proficient Service Technician to enhance our service department.Work Schedule: Tuesday to SaturdayOur facility offers a clean, temperature-controlled workspace.Key Responsibilities:Possess and maintain the necessary tools for job functions.Ensure cleanliness and organization of the workspace, tools, and service...


  • Sugar Land, Texas, United States Fuel Powersports Full time

    Position OverviewFuel Powersports is seeking a proficient Service Technician to enhance our operations.Work Schedule: Tuesday to SaturdayEnvironment: Clean, temperature-controlled workspaceKey Responsibilities:Possess the necessary tools to execute job responsibilities effectively.Maintain a tidy and organized workspace, including tools and service...


  • Sugar Land, Texas, United States Catholic Health Initiatives Full time

    Job SummaryCatholic Health Initiatives is seeking a highly skilled and dedicated Security Officer to join our team at St. Lukes HealthSugar Land Hospital. As a Security Officer, you will play a critical role in ensuring the safety and security of our patients, visitors, and employees.Key ResponsibilitiesPatrol assigned areas to deter, detect, and investigate...

  • PACU Nurse

    2 weeks ago


    Sugar Land, Texas, United States Common Spirit Full time

    Job SummaryWe are seeking a skilled Registered Nurse to join our Perioperative Care team at CommonSpirit Health. As a PACU Nurse, you will play a critical role in providing high-quality patient care and ensuring a smooth transition for patients throughout the facility.Key ResponsibilitiesAssess patient needs and priorities of care through assessment,...