Quality Assurance Specialist

4 weeks ago

Fishers, Indiana, United States INCOG BioPharma Services Full time
Job Summary

This role is a great opportunity to work with Quality Control personnel within the realm of the Quality Assurance department. The candidate will have the opportunity to learn about the equipment used to perform testing as well as the different methods for performing each test. The ideal candidate will be able to communicate with other data reviewers to ensure adherence to quality standards. The Quality Assurance Data Review Specialist is responsible for reviewing and approving Quality Control documentation, including all Quality Control Chemistry and Quality Control Microbiology data. The Data Review Specialist will work in coordination with the Quality Assurance Technical Manager to perform periodic walkthroughs of the Quality Control laboratories to ensure good laboratory practices are followed and the areas meet regulatory inspection readiness.

Key Responsibilities
  • Perform laboratory data review processes for incoming materials, in-process, finished product, and stability testing from QC Chemistry and QC Microbiology.
  • Partner with Quality Control in the data analysis and data review process.
  • Establish an ongoing state of readiness in the exercising of rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions.
  • In coordination with QC management, use knowledge of quality principles, cGMPs, and regulatory standards to maintain a state of constant inspection-readiness in the QC laboratories.
  • Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, etc.) to ensure data integrity for all Quality Assurance and Quality Control site policies, procedures, and testing records.
  • Use technical skills and applied statistics to analyze and track laboratory investigations and to identify sources of variability and error in QC processes. Use data trends to apply a systematic approach to resolve technical issues, prevent errors, identify improvement opportunities, and implement continuous improvement plans.
Requirements
  • Exemplifies excellent interpersonal skills and can develop productive working relationships with colleagues, customers, suppliers, and partners. Demonstrated ability to influence positive outcomes without direct reporting authority.
  • Demonstrates excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences.
  • Thrives in a team environment but can work autonomously with strong self-management and organizational skills.
  • Commits to a culture of quality with skills including attention to detail, on-time delivery, and efficiency.
  • Upholds a customer-centric mindset.
Preferred Qualifications
  • Bachelor's Degree required; degree preferred to be in Science (Chemistry, Biology, or Biochemistry); advanced degree preferred.
  • Minimum of 2+ years of biopharma industry experience, with at least 1 year of hands-on experience with isolator-based aseptic manufacturing Quality required.
About INCOG BioPharma Services
At INCOG BioPharma, we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.

  • Quality Assurance Specialist

    4 weeks ago

    Fishers, Indiana, United States INCOG BioPharma Services Full time

    This role offers a unique opportunity to collaborate with Quality Control personnel within the Quality Assurance department.The ideal candidate will have the chance to learn about the equipment used for testing and the various methods for performing each test.Effective communication with data reviewers is crucial to ensure adherence to quality standards.The...

  • Quality Assurance Compliance Specialist

    4 weeks ago

    Fishers, Indiana, United States INCOG BioPharma Services Full time

    Job Summary: We are seeking a highly skilled Quality Assurance Compliance Specialist to join our team at INCOG BioPharma Services. The successful candidate will be responsible for ensuring site compliance with Regulations, Industry Standards, and organizational SOPs. This role will also involve championing and developing the organization's Quality Mindset...

  • Software Quality Assurance Engineer

    4 weeks ago

    Fishers, Indiana, United States Ampcus Full time

    Software Test EngineerAmpcus Inc. is a global provider of technology and business consulting services. We are seeking a highly motivated candidate to join our team as a Software Test Engineer.Key Responsibilities:Understand customer needs and collaborate with developers, analysts, and tech leads to identify test scenarios.Propose technical solutions and play...

  • Travel Nurse ICU Specialist

    3 weeks ago

    Fishers, Indiana, United States Assured Nursing Inc Full time

    Job Title: ICU Travel Nurse RN PositionJob Summary:Assured Nursing Inc is seeking a skilled ICU travel nurse RN to join our team in Fishers, Indiana. The ideal candidate will possess a current state license as a RN and have at least 2 years of recent experience as a ICU RN.Job Responsibilities:Provide high-quality patient care in the ICU setting.Collaborate...

  • Fabrication Specialist

    4 weeks ago

    Fishers, Indiana, United States Dant Clayton Corporation Full time

    Job OverviewDant Clayton Corporation, a leading manufacturer of custom architectural railing, seeks a skilled Fabrication Specialist to join our team at our Fishers, Indiana facility.As a Fabrication Specialist, you will be responsible for fabricating and assembling structural steel and ornamental iron components according to blueprints and shop drawings.Key...

  • Veterinary Care Specialist

    4 weeks ago

    Fishers, Indiana, United States PetVet365 Indianapolis Full time

    PetVet365 Indianapolis is seeking a skilled Veterinary Care Specialist to provide exceptional medical care to pets and their owners. Our state-of-the-art facility is equipped with the latest technology and staffed by a team of compassionate, experienced professionals.As a Veterinary Care Specialist, you will be responsible for delivering high-quality medical...

  • Travel Nurse ICU Specialist

    4 weeks ago

    Fishers, Indiana, United States TotalMed Staffing Full time

    Job Title: Travel Nurse ICU SpecialistJob Type: TravelSpecialty: ICU - Intensive Care UnitDiscipline: RNDuration: 13 weeksShift: 12 hours, nightsEmployment Type: TravelAbout the Job:TotalMed Staffing is seeking a travel nurse ICU specialist for a 13-week assignment in a reputable healthcare facility. As a travel nurse ICU specialist, you will provide...

  • MRI Imaging Specialist

    4 weeks ago

    Fishers, Indiana, United States RAYUS Radiology Full time

    At RAYUS Radiology, we are seeking a skilled MRI Imaging Specialist to join our team in Fishers. This part-time position involves working 20 hours per week, Monday through Friday, from 10:00am to 2:00pm. As an MRI Imaging Specialist, you will be responsible for performing routine and advanced MRI procedures on designated portions of the body, ensuring...

  • Travel Nurse ICU Specialist

    4 weeks ago

    Fishers, Indiana, United States Uniti Med Full time

    Uniti Med is seeking a skilled travel nurse ICU specialist to fill a travel nursing position in a reputable healthcare facility.Job Details:Specialty: ICU - Intensive Care UnitDiscipline: RNEmployment Type: TravelAs a travel nurse ICU specialist, you will have the opportunity to work in a dynamic and challenging environment, providing high-quality patient...

  • Ice Surface Specialist

    3 weeks ago

    Fishers, Indiana, United States ASM Global Full time

    Job Summary:As an Ice Surface Specialist at ASM Global, you will be responsible for ensuring the ice surface is smooth and clean. This involves operating and maintaining the Zamboni machine, performing routine maintenance and repairs on equipment, and monitoring and adjusting ice temperature and quality. Additionally, you will assist with ice resurfacing...

  • Automotive Refinish Specialist

    4 weeks ago

    Fishers, Indiana, United States Don Hinds Ford Inc Full time

    Job OverviewAt Don Hinds Ford Inc, we're seeking a skilled Automotive Refinish Specialist to join our team. As a key member of our body shop, you'll be responsible for producing high-quality refinishes that meet our customers' expectations. Your expertise will be essential in ensuring our vehicles leave our shop looking like new.Responsibilities:* Preparing...

  • Ice Surface Specialist

    4 weeks ago

    Fishers, Indiana, United States ASM Global Full time

    Job Summary:As an Ice Surface Specialist at ASM Global, you will be responsible for ensuring the ice surface is smooth and clean. This involves operating and maintaining the Zamboni machine, performing routine maintenance and repairs on equipment, and monitoring and adjusting ice temperature and quality. Additionally, you will assist with ice resurfacing...

  • Medical Assistant I-Primary Care Specialist

    4 weeks ago

    Fishers, Indiana, United States Indiana University Health Full time

    Job Title: Medical Assistant I-Primary CareWe are seeking a highly skilled Medical Assistant I-Primary Care to join our team at Indiana University Health.Job Summary:Under the supervision of a designated supervisor and assigned physician, the Medical Assistant I-Primary Care will perform duties associated with direct patient care and clinical direction to...

  • Travel Nurse ICU Specialist

    4 weeks ago

    Fishers, Indiana, United States Assured Nursing Inc Full time

    Assured Nursing Inc is seeking a dedicated ICU nurse for a travel nursing opportunity in Indiana.Job DetailsSpecialty: ICU - Intensive Care UnitDiscipline: RNDuration: 13 weeksShift: 12 hours, nightsEmployment Type: TravelThe ideal candidate will possess a current state license as a RN and have at least 2 years of recent experience as an ICU RN. The position...

  • Hospice Care Specialist

    4 weeks ago

    Fishers, Indiana, United States Community Health Network Full time

    Job SummaryAs a Hospice Care Specialist at Community Health Network, you will provide exceptional care to patients in need. This role requires a minimum of two years of hospice care experience and an Indiana CNA license. You will work under the direction of a registered nurse to provide personal care and complete simple procedures related to hospice care....

  • Eye Care Specialist

    4 weeks ago

    Fishers, Indiana, United States Visionworks Full time

    We are seeking a skilled Eye Care Specialist to join our team at Visionworks in Fishers, IN. As an Optometrist, you will provide high-quality vision care to our patients, performing comprehensive eye exams, diagnosing and treating ocular disease, and prescribing corrective lenses.The ideal candidate is committed to delivering quality patient care and is...

  • Education Specialist

    3 weeks ago

    Fishers, Indiana, United States Primrose School of West Fishers Full time

    Job OverviewAs an Education Specialist at Primrose School of West Fishers, you will play a vital role in creating a nurturing environment that fosters the social, emotional, cognitive, creative, and physical development of young children.Key ResponsibilitiesImplement the Balanced Learning curriculum in a way that promotes curiosity, creativity, and...

  • Window Installation Specialist

    4 weeks ago

    Fishers, Indiana, United States The Glass Guru of Indy North Full time

    Job OverviewAt The Glass Guru of Indy North, we're seeking a skilled Window Installation Specialist to join our team. As a Full-Time Customer Installer, you'll be responsible for delivering exceptional customer experiences and ensuring seamless window installation processes.Benefits of working with us:Competitive compensation packageComprehensive benefits,...

  • Dental Care Specialist for Children and Young Adults

    3 weeks ago

    Fishers, Indiana, United States Pippin Dental & Braces - a Benevis company Full time

    Are you passionate about creating happy, healthy smiles for children and young adults? We are seeking a Children's Dental Specialist to play a key role in providing excellent dental care to our community.Responsibilities:Provide dental services to patients with the support of our dedicated team.Adhere to all government regulations, company standards, and...

  • Media Advertising Operations Coordinator

    3 weeks ago

    Fishers, Indiana, United States Mood Media Full time

    Job SummaryThe Media Advertising Operations Specialist is responsible for the coordination of all advertising campaigns. This includes but not limited to pre-campaign planning, post-campaign reporting, internal communication, creative approvals, and quality assurance. The ideal candidate is detail oriented and enjoys team collaboration. The Media Advertising...