Regulatory Quality Assurance Specialist

7 days ago


Vincennes, Île-de-France, United States Scilex Pharmaceuticals Inc. Full time
Job Description

Scilex Pharmaceuticals Inc. is a leading developer and commercializer of non-opioid pain management products.

Estimated Salary: $175,000 - $250,000 per annum

This role requires a highly experienced Regulatory Quality Assurance Specialist with expertise in quality control/analytical testing for GMP manufacturing of commercial products and/or late stage/Phase 3 clinical pipeline.

  • Main Responsibilities:
  • Support analytical development and quality control/analytical testing of commercial or late-stage clinical small molecule products.
  • Review/support CMO manufacturing services agreements and quality agreements from analytical testing perspectives.
  • Develop and validate analytical methods for commercial and clinical products.
  • Ensure compliance with GMP regulations from analytical testing perspectives for raw materials and packaging components required for manufacturing of drug substances and commercial and clinical products.
  • Collaborate with Quality Assurance for quality audits and investigations of OOS, deviations, change controls, CAPA, and temperature excursions.
  • Support tracking, trending, and analyzing release and stability data, manufacturing records, batch failures, OOS/OOT, investigations, deviations, change controls, CAPA, product complaints as required.

Key Qualifications:

  • Bachelor's degree in analytical chemistry, biochemistry, biology, chemical sciences, or relevant scientific discipline.
  • Minimum of 8 to 12 years of experience in analytical development and quality control for commercial products or late-stage, Phase 3 clinical product in pharmaceutical or biologic companies.
  • Proven track record of accomplishments in analytical development and quality control/analytical testing of commercial or late-stage clinical small molecule or biological products.


  • Vincennes, Île-de-France, United States One Medical Full time

    About UsOne Medical is a pioneering primary care organization that's redefining the healthcare experience. By making quality care more accessible, affordable, and enjoyable, we're empowering individuals to take control of their well-being.We're not just another doctor's office. Our mission is to transform healthcare by improving the experience for everyone...


  • Vincennes, Île-de-France, United States Quality Metal Spinning and Machining Full time

    Job DescriptionQuality Metal Spinning & Machining, a pioneer in metal spinning in Silicon Valley, seeks an experienced Swiss Lathe Operator/Programmer.We offer a long-term, stable career opportunity with a competitive salary range of $25-$35 per hour.Responsibilities include:Completing first-time and repeat job set-ups on Swiss turning lathesManaging daily...


  • Vincennes, Île-de-France, United States One Medical Full time

    About UsOne Medical is a primary care solution challenging the industry status quo by making quality care more affordable, accessible and enjoyable.We're on a mission to transform healthcare, which means improving the experience for everyone involved - from patients and providers to employers and health networks.Our Services:Seamless in-office and 24/7...


  • Vincennes, Île-de-France, United States Vi Living Full time

    OverviewVi Living is recognized as a Great Place to Work and one of Glassdoor's 100 Best Companies to work for. Our organization offers a supportive environment with opportunities for growth and development.ResponsibilitiesThe MDS Coordinator/Floor Nurse will oversee the completion of the Minimum Data Set (MDS) and Resident Assessment Instrument (RAI) while...


  • Vincennes, Île-de-France, United States Basurto Painting LLC Full time

    Job DescriptionWe're seeking a highly skilled High End Residential Painter to join our team at Basurto Painting LLC. As a member of our crew, you'll be responsible for delivering exceptional results in luxury home painting projects.About the RolePrecision: Delivering flawless results is paramount in high-end painting, where a single brush stroke can make all...


  • Vincennes, Île-de-France, United States ProCare Therapy Full time

    Job SummaryWe are seeking a highly skilled Occupational Therapist to join our team in a school-based setting. As an Occupational Therapist, you will work with students to develop and implement individualized treatment plans to improve their fine motor skills, sensory processing, and visual-motor integration.About ProCare TherapyProCare Therapy is a leading...


  • Vincennes, Indiana, United States Futaba Indiana Of America Full time

    Job SummaryThis position is responsible for ensuring that parts manufactured at FIA meet TIS requirements. The role involves verifying that all processes related to production and delivery of parts are followed through audits.Key ResponsibilitiesPerform dimensional and attribute checks using check fixtures, caliper, taper gauge, feeler gauge, and surface...


  • Vincennes, United States Futaba Indiana Of America Full time

    Job Type Full-time Description General Position Summary The primary responsibility of this role is to monitor/maintain/improve quality indicators both in house and supplier manufacturing. Reporting to the Quality Manager, the person in this role will support the Quality Engineering department's objective to support the overall success of the company. ...


  • Vincennes, Indiana, United States HealthTrust Workforce Solutions CHS Full time

    HealthTrust Workforce Solutions CHS is a leading healthcare provider seeking an experienced Diagnostic Imaging Specialist for a contract opportunity in Knox, Indiana.About the JobWe offer a competitive salary of $45 per hour, with free private furnished housing or tax-free subsidy available. As a Diagnostic Imaging Specialist, you will work as part of a...


  • Vincennes, Indiana, United States Vincennes University Full time

    About the PositionVincennes University is seeking a qualified Academic Support Specialist to join our team at Ben Davis High School.Job OverviewThis part-time position will provide one-on-one or small group support for early college students, working closely with faculty and staff to monitor academic progress and identify solutions for struggling...


  • Vincennes, Indiana, United States Planet Healthcare Full time

    We are seeking a highly skilled Diagnostic Imaging Specialist to join our team in Knox, Indiana. This is a travel opportunity that offers the chance to work with a variety of patients and medical professionals.About the JobThe Diagnostic Imaging Specialist will be responsible for performing ultrasound examinations using state-of-the-art equipment. The ideal...


  • Vincennes, Indiana, United States ADEX Healthcare Staffing LLC Full time

    ADEX Healthcare Staffing LLC is seeking a highly skilled Mobile Radiology Imaging Specialist for a 13-week travel assignment in Indiana. With our extensive experience in placing healthcare professionals across the US since 2004, we are confident that this opportunity will provide you with the ideal platform to grow your career.About the AssignmentJob Title:...


  • Vincennes, Indiana, United States Good Samaritan Full time

    About the RoleGood Samaritan is seeking a dedicated and compassionate Nurse Care Specialist to join our team. As a key member of our healthcare staff, you will be responsible for providing exceptional patient care and contributing to our tradition of excellence.Job SummaryThe Nurse Care Specialist will work closely with our interdisciplinary team to develop...


  • Vincennes, Indiana, United States ProLocums Full time

    About This OpportunityWe are seeking a skilled Medical Oncology Specialist to join our team at ProLocums. As an experienced professional in the field, you will be responsible for providing high-quality patient care and contributing to a collaborative healthcare environment.


  • Vincennes, Indiana, United States Uniti Med Full time

    At Uniti Med, we understand the importance of providing exceptional healthcare services to our patients. As a Diagnostic Imaging Specialist - Ultrasound Technologist, you will play a vital role in delivering high-quality patient care and ensuring accurate diagnoses.About the RoleWe are seeking an experienced Ultrasound Technologist to join our team on a...


  • Vincennes, Indiana, United States Host Healthcare Full time

    Job Opportunity for CT TechnologistWe are seeking a skilled Computed Tomography Technologist to join our team at Host Healthcare. As a travel imaging specialist, you will be responsible for operating computerized tomography equipment to produce high-quality images of the body.The successful candidate will have experience in CT scanning and a strong...


  • Vincennes, Indiana, United States National Staffing Solutions-Surgical Services Full time

    About the RoleNational Staffing Solutions-Surgical Services is seeking a skilled travel Ultrasound Technologist for a 13-week assignment in Indiana. As a Mobile Diagnostic Imaging Specialist, you will have the opportunity to gain valuable experience and contribute to delivering high-quality patient care.Key ResponsibilitiesConduct ultrasound examinations and...


  • Vincennes, Indiana, United States Anders Group Full time

    Company OverviewAnders Group is a renowned staffing agency in the healthcare sector, committed to providing exceptional customer service and quality placements. Compensation PackageWe offer competitive compensation packages that include tax-free stipends, health insurance, dental insurance, vision insurance, life insurance, 401(k), licensure reimbursement,...


  • Vincennes, Indiana, United States Host Healthcare Full time

    At Host Healthcare, we're committed to providing a seamless experience for our travel healthcare professionals. As a Radiology Travel Specialist, you'll be an integral part of our team, responsible for delivering high-quality patient care in a dynamic and fast-paced environment.About the RoleWe're seeking an experienced CT Technologist to join our team on a...


  • Vincennes, Indiana, United States SkinCure Oncology Full time

    About UsSkinCure Oncology is a pioneering provider of superficial radiotherapy solutions in the dermatology arena, dedicated to delivering high-quality patient care and exceptional customer service. With a focus on quality and customer satisfaction, we strive to be the trusted partner for dermatologists seeking innovative SRT solutions.Job SummaryWe are...


  • Vincennes, Indiana, United States Ethos Medical Staffing Full time

    Ethos Medical Staffing is a nurse-owned and operated staffing agency that truly cares for those who care for our communities.We are seeking a skilled Diagnostic Imaging Specialist to join our team in Knox, Indiana. As a travel Ultrasound Technologist, you will have the opportunity to work with various healthcare facilities and patients while experiencing...


  • Vincennes, Indiana, United States KCARC Full time

    Job Title: Direct Support Professional - Home Care Specialist">About KCARC: KCARC is a dynamic organization dedicated to providing exceptional support services for individuals with developmental disabilities. Our team of professionals is committed to fostering growth, independence, and quality of life for our participants.">Job Summary: We are seeking a...

  • Graphic Design

    4 months ago


    Vincennes, United States Vincennes University Full time

    Description Vincennes University is seeking applicants for the Graphic Design & Content Specialist position. This is a full-time professional staff position located at the VU Main site. The successful candidate will be responsible for creating visually appealing and impactful designs that align with our brand identity across various platforms. This...


  • Vincennes, Indiana, United States AHS Staffing Full time

    Job DescriptionAHS Staffing is seeking a Medical Imaging Specialist for a 13-week contract in Knox, Indiana.About the JobThis position involves working as an Ultrasound Technologist in a healthcare setting. The successful candidate will be responsible for conducting medical imaging procedures, maintaining patient records, and collaborating with other...


  • Vincennes, United States Good Samaritan Full time

    Job DescriptionJob Summary:Primary responsibilities include the utilization of highly skilled therapeutic and diagnostic techniques in the treatment of patients of all ages in all care settings.Essential Job Duties: Performs and analyzes arterial and capillary sticks on infants and pediatric patients as applicable. Performs and interprets pulse oximetry,...

  • Nurse Practitioner

    7 days ago


    Vincennes, Indiana, United States Bridgepointe Health Campus Full time

    We are seeking a skilled Registered Nurse to join our team at Bridgepointe Health Campus. As a long-term care specialist, you will have the opportunity to make a meaningful difference in the lives of our residents and their families.About UsAt Bridgepointe Health Campus, we pride ourselves on providing exceptional care and services to our residents. Our goal...