Lead Technician QA Specialist

4 days ago

Concord, North Carolina, United States Lilly Full time

About Lilly

Lilly is a global healthcare leader dedicated to making life better for people around the world. We unite caring with discovery to develop innovative medicines that improve the understanding and management of disease.

Job Summary

We are seeking a highly skilled Lead Technician QA Specialist to provide QA oversight to GMP operations. The successful candidate will be responsible for supporting the start-up and qualification of our Concord site, collaborating with cross-functional teams, and ensuring compliance with site procedures.

Key Responsibilities

  • QA Support: Provide QA oversight to GMP operations, ensuring compliance with regulatory requirements and site procedures.
  • Start-up and Qualification: Support the start-up and qualification of the Concord site, including the development of Standard Operating Procedures and associated Forms, Tools, and Training.
  • Collaboration: Collaborate with cross-functional teams, including manufacturing, quality, and engineering, to ensure seamless operations and effective communication.
  • Compliance: Ensure compliance with regulatory requirements, site procedures, and good documentation practices.
  • Troubleshooting: Troubleshoot and resolve equipment alarms and other issues in quality systems, such as Trackwise and MES.
  • Communication: Maintain open communication with cross-functional teams and area leadership, ensuring effective issue escalation and resolution.
  • Inspection Readiness: Support the execution of inspection readiness activities, including site self-inspections.
  • Project Initiatives: Support project initiatives needed for the project and Quality function.
  • Compliance Issues: Communicate any compliance issues associated with the project or site to Quality Management.
  • Product Quality Impact: Evaluate potential product quality impact for any GMP-related incident and support the investigation and assist with safety investigations.

Requirements

  • Education: High School diploma or equivalent.
  • Knowledge: Knowledge of cGMP practices, including good documentation practices, data integrity, and regulatory compliance.
  • Communication: Demonstrated ability to communicate with cross-functional teams, including good oral and written communication skills.
  • Attention to Detail: Strong attention to detail.
  • Independence: Ability to work independently with minimal supervision.
  • Computer Skills: Proficiency with computer systems, including Trackwise, MES, and Microsoft Programs.
  • Work Environment: Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate, Project, and Site Goals.
  • Eligibility: Qualified candidates must be legally authorized to be employed in the United States.

Preferred Qualifications

  • Education: Associates or Bachelor's degree in a science, engineering, computer, or pharmaceutical-related field of study.
  • Experience: Previous experience with GMP manufacturing equipment prep, formulation, filling, and visual inspection.
  • Technical Writing: Previous technical writing experience.
  • Training and Mentoring: Technical aptitude and ability to train and mentor other team members.

  • Lead Technician QA Specialist

    6 days ago

    Concord, North Carolina, United States Lilly Full time

    Job SummaryLilly is seeking a highly skilled Lead Technician QA Specialist to provide quality assurance oversight to our GMP operations. The successful candidate will be responsible for ensuring compliance with regulatory requirements and industry standards.Key ResponsibilitiesProvide QA support for the start-up and qualification of our Concord...

  • Lead Technician QA Specialist

    6 days ago

    Concord, North Carolina, United States Lilly Full time

    Job SummaryLilly is seeking a highly skilled Lead Technician QA Specialist to provide quality assurance oversight to our GMP operations. The successful candidate will be responsible for ensuring compliance with regulatory requirements and industry standards.Key ResponsibilitiesProvide QA support for the start-up and qualification of our Concord...

  • Lead Technician QA Specialist

    2 days ago

    Concord, North Carolina, United States Lilly Full time

    Job SummaryLilly is seeking a highly skilled Lead Technician QA Specialist to provide quality assurance oversight to GMP operations. The successful candidate will be responsible for ensuring the quality and integrity of our products, while collaborating with cross-functional teams to drive process improvements.Key ResponsibilitiesProvide QA support for the...

  • Quality Assurance Technician Lead

    6 days ago

    Concord, North Carolina, United States Lilly Full time

    Job SummaryLilly is seeking a highly skilled Lead Technician QA Specialist to provide quality assurance oversight to our GMP operations. The successful candidate will be responsible for ensuring compliance with regulatory requirements and industry standards.Key ResponsibilitiesProvide QA support for the start-up and qualification of our Concord...

  • Quality Assurance Floor Support Lead

    4 days ago

    Concord, North Carolina, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Floor Support Lead to join our team at BioSpace, Inc. as a key member of our Quality Assurance department. The successful candidate will be responsible for providing leadership to a team of QA Specialists, while reporting directly to the Associate Director - QA Parenteral.Key...

  • Lead Field Service Technician

    2 weeks ago

    Concord, North Carolina, United States WMH Corporation Full time

    Lead Field Service Technician - Heavy EquipmentDepartment: Service Employment Type: Full Time Location: BR11- CONCORD, NC Reporting To: Craig Carrigan OverviewJoin Our Team: Become a Lead Field Service TechnicianWhy Work With Us?At WMH Corporation, we are dedicated to providing outstanding material handling solutions to our clients. Our commitment to...

  • Medical Instrument Sterilization Specialist

    2 weeks ago

    Concord, North Carolina, United States First Connect Health Full time

    Job Overview:First Connect Health is looking for a meticulous Medical Instrument Sterilization Specialist to enhance our healthcare team. The successful candidate will be responsible for ensuring that all medical tools and devices are effectively sterilized and preserved to uphold patient safety standards.Key Responsibilities:- Perform cleaning,...

  • Collision Repair Specialist

    1 week ago

    Concord, North Carolina, United States Finks Unlimited Full time

    Job OverviewBenefits and Perks401K Matching ProgramComplimentary Life Insurance CoveragePaid Time OffCompetitive Salary Package$2,000 Signing Bonus after 90 Days of EmploymentPosition SummaryWe are seeking a proficient Collision Repair Specialist to enhance our thriving repair facility. In this role, you will support our clientele by identifying and...

  • Travel Imaging Specialist

    2 weeks ago

    Concord, North Carolina, United States HealthCare Support Full time

    HealthCare Support is currently seeking a travel Imaging Specialist for an exciting opportunity. Position Overview & RequirementsSpecialty: Imaging SpecialistDiscipline: Allied Health ProfessionalDuration: 14 weeks40 hours per weekShift: 8 hours, eveningsEmployment Type: TravelBenefits: Up to $500 travel reimbursement on first paycheck Overtime and Loyalty...

  • Travel Radiology Specialist

    2 days ago

    Concord, North Carolina, United States Focus Full time

    Job SummaryWe are seeking a skilled Radiology Technician to join our team as a Travel Radiology Specialist. This is a fantastic opportunity for a motivated and experienced professional to work with a reputable healthcare staffing agency.Job ResponsibilitiesProvide high-quality radiology services to patients in a variety of settings.Work collaboratively with...

  • Radiology Imaging Specialist

    20 hours ago

    Concord, North Carolina, United States SkyBridge Healthcare Full time

    Job OverviewSkyBridge Healthcare is seeking a skilled Radiology Imaging Specialist to join their team for a 13-week assignment in a dynamic healthcare environment.Key ResponsibilitiesProvide high-quality diagnostic imaging services to patients, utilizing advanced medical imaging equipment.Collaborate with healthcare professionals to ensure accurate and...

  • Automotive Service Specialist

    2 weeks ago

    Concord, North Carolina, United States Subaru Concord Full time

    Automotive Express Service Specialist / Mechanic COMPETITIVE PAY + BENEFITS Relocation Assistance Available 5-Day Work Schedule No Sundays RequiredSubaru Concord is in search of Express Service Specialists from various automotive backgrounds to enhance our service department's efficiency and effectiveness. We value team players who thrive in a collaborative...

  • Radiology Imaging Specialist

    3 days ago

    Concord, North Carolina, United States Aequor Allied Full time

    Job Opportunity for Radiology Imaging SpecialistAequor Allied is seeking a skilled Radiology Imaging Specialist to join their team in a travel position.Job DetailsSpecialty: Radiology ImagingEmployment Type: TravelShift: 12 hoursHours per Week: 36Assignment Length: 13 weeksAequor Allied is a leading provider of healthcare staffing solutions. As a Radiology...

  • Medical Imaging Technician

    7 days ago

    Concord, North Carolina, United States ADEX Healthcare Staffing LLC Full time

    ADEX Healthcare Staffing LLC is seeking a skilled Radiology Imaging Specialist for a travel assignment in a dynamic healthcare environment.Job Summary:Job Title: Radiology Imaging SpecialistSpecialty: RadiologyDuration: 13 weeksHours: 36 hours per weekShift: 12 hours, daysEmployment Type: TravelAbout the Job:We are seeking a highly skilled Radiology Imaging...

  • Diagnostic Imaging Specialist

    4 days ago

    Concord, North Carolina, United States Talent4Health Full time

    Job Title: Diagnostic Imaging SpecialistJob Summary:Talent4Health is seeking a skilled Diagnostic Imaging Specialist to join our team. As a Diagnostic Imaging Specialist, you will be responsible for operating medical imaging equipment to produce high-quality images for diagnostic purposes.Responsibilities:Operate computed tomography (CT) scanners to produce...

  • Radiology Imaging Specialist

    5 days ago

    Concord, North Carolina, United States TotalMed Allied Full time

    Job Title: Radiology Imaging SpecialistJob Summary:TotalMed Allied is seeking a skilled Radiology Imaging Specialist to join our team for a travel assignment in a dynamic healthcare setting. As a Radiology Imaging Specialist, you will be responsible for operating imaging equipment to produce high-quality diagnostic images for medical professionals to...

  • Radiology Imaging Specialist

    4 days ago

    Concord, North Carolina, United States SkyBridge Healthcare Full time

    SkyBridge Healthcare is seeking a skilled Radiology Imaging Specialist for a travel assignment in a dynamic healthcare setting. Job Summary: Specialty: Radiology Imaging SpecialistDuration: 13 weeksShift: 8 hours, eveningsEmployment Type: Travel About the Job: As a Radiology Imaging Specialist, you will be responsible for performing diagnostic imaging...

  • Diagnostic Imaging Specialist

    3 days ago

    Concord, North Carolina, United States Healthcare Support Full time

    Job Title: Diagnostic Imaging SpecialistJob Summary:Healthcare Support is seeking a skilled Diagnostic Imaging Specialist to join our team. As a Diagnostic Imaging Specialist, you will be responsible for operating and maintaining imaging equipment, preparing patients for exams, and producing high-quality images for diagnostic...

  • Radiology Imaging Specialist

    4 days ago

    Concord, North Carolina, United States Triage Staffing Full time

    Job Title: Radiology Imaging SpecialistJob Type: TravelLocation: Concord, NCJob Description:Triage Staffing is seeking a skilled Radiology Imaging Specialist for a travel assignment in Concord, NC.Job Summary:We are looking for a highly motivated and experienced Radiology Imaging Specialist to join our team. As a Radiology Imaging Specialist, you will be...

  • Radiology Imaging Specialist

    5 days ago

    Concord, North Carolina, United States TotalMed Allied Full time

    Job Title: Radiology Imaging SpecialistJob Summary:TotalMed Allied is seeking a skilled Radiology Imaging Specialist to join our team for a travel assignment in a dynamic healthcare setting. As a Radiology Imaging Specialist, you will be responsible for operating imaging equipment, preparing patients for exams, and maintaining a safe and efficient imaging...