Quality Assurance Engineer

5 days ago

Noblesville, United States Yoh Full time
Yoh is seeking a Quality Assurance Engineer for our pharmaceutical client here in Noblesville, IN. This is a 6 month contract opportunity on day shift and must be able to work on W2

Location: Noblesville, IN (onsite)
Pay: $30-$40/hr.
Hours: M-F, 8 am - 5 pm
Type: 6 month Contract

Summary of Position

The Senior Quality Assurance Engineer is responsible for the Quality oversight for Validation, Engineering and Maintenance at the site. This position requires strong technical and quality skills. The position reports directly to the Senior Manager or Senior Director of Quality Assurance. Knowledge in pharmaceutical quality systems with proficiency in quality oversight of: Validation, Engineering, Maintenance, Manufacturing, QC, Regulatory, CAPA, Deviations, Out of Specification Investigations, and Annual Product Reviews.

Essential Skill/Functions
  • Take a lead role for site/corporate development and maintenance of facility's quality systems and procedures.
  • Review and approve Change Control/Process Management Documents involving product or process changes.
  • Key personnel for FDA or other regulatory agencies for on-site audits.
  • Reviews and approves IOQs, requirement documents, SOPs, validation documents and data integrity assessments.
  • Assemble, analyze and report QA system data to ensure regulatory compliance, identify trends and to identify areas of improvement.
  • Conduct quality audits and develop and assess subsequent corrective action recommendation(s).
  • Developing procedures, statistical evaluations, and remediation of systems.
  • Ability to adapt quickly in a fast-paced dynamic environment.
  • Ability to communicate with and positively influence broad and diverse populations within and outside the organization.
  • Ensure a safe and quality working environment through training, awareness and compliance to safety guidelines and SOP's.
  • Ensure the maintenance of the department, premises and equipment.
  • Additional areas of responsibility may include developing specifications, standard operating procedures; providing quality system training and actively participating in Quality Review Board meetings.
  • Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)


Requirements
  • Bachelor of Science in Biology, Chemistry, Life Sciences or related field required
  • Five or more years of relevant Quality or Validation experience in a finished pharmaceutical manufacturing environment with strong understanding of and exposure to applicable quality systems.
  • Experience in supporting on-site inspections for regulatory agencies.
  • Significant experience investigating Deviations and other variances.
  • Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems.
  • Working knowledge of cGMP guidelines and their application in a controlled aseptic environment
  • Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcome.
  • Must have experience with statistical tools Proficient in use of Microsoft suite of products.




Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

  • Director of Engineering

    2 weeks ago

    Noblesville, United States Entegee Full time

    We are seeking an experienced Engineering Manager with extensive experience in the biotechnology or pharmaceutical industry. This role is responsible for leading the engineering team in managing, implementing, and validating manufacturing systems and control processes in compliance with cGMP and Process Validation regulations. The ideal candidate will have a...

  • Director of Engineering Facilities and Reliability

    1 month ago

    Noblesville, United States Entegee Full time

    Job OverviewEntegee is seeking a seasoned Director of Engineering Facilities and Reliability to lead their engineering team in designing and implementing control systems compliant with Process Validation regulations.The ideal candidate will have a strong background in cGMP manufacturing, equipment maintenance, and capital project management, with a proven...

  • Chief Reliability Officer

    4 weeks ago

    Noblesville, United States Entegee Full time

    Job Summary:Entegee seeks a highly skilled Chief Reliability Officer - Engineering and Facilities to oversee the design, implementation, and maintenance of its engineering and facilities operations. The ideal candidate will have a strong background in cGMP manufacturing, equipment maintenance, and capital project management, with a proven track record of...

  • Director Engineering Facilities and Reliability

    2 months ago

    Noblesville, United States Entegee Full time

    Job DescriptionJob DescriptionSummary: Seeking a Director of Engineering Facilities and Reliability with expertise in cGMP manufacturing, equipment maintenance, and capital project management within the biotechnology or pharmaceutical industry.Job Requirements:Bachelor's degree in engineering.15+ years of relevant experience in cGMP manufacturing and...

  • Design Engineer

    2 months ago

    Noblesville, United States Gaylor inc. Full time

    Job DescriptionJob DescriptionDesign EngineerUS-IN-NoblesvilleJob ID: 2024-5288Type: Regular Full-Time# of Openings: 4Category: EngineeringInnovation Indianapolis, INOverviewGAYLOR ELECTRIC INC. OUR VISION. The HIGHEST PERFORMING NATIONAL CONTRACTOR OF EXCELLENCE, delivering on our Cornerstone of Reliable Resources, Outcomes, and Insights; dedicated to...

  • Electrical Engineering Manager

    4 weeks ago

    noblesville, United States Gaylor inc. Full time

    Electrical Engineering ManagerUS-IN-NoblesvilleJob ID: 2024-5290Type: Regular Full-Time# of Openings: 2Category: EngineeringInnovation Indianapolis, INOverviewOUR VISION. The HIGHEST PERFORMING NATIONAL CONTRACTOR OF EXCELLENCE, delivering on our Cornerstone of Reliable Resources, Outcomes, and Insights; dedicated to innovation, quality, and our genuine care...

  • Electrical Engineering Manager

    2 months ago

    Noblesville, United States Gaylor inc. Full time

    Job DescriptionJob DescriptionElectrical Engineering ManagerUS-IN-NoblesvilleJob ID: 2024-5290Type: Regular Full-Time# of Openings: 2Category: EngineeringInnovation Indianapolis, INOverviewOUR VISION. The HIGHEST PERFORMING NATIONAL CONTRACTOR OF EXCELLENCE, delivering on our Cornerstone of Reliable Resources, Outcomes, and Insights; dedicated to innovation,...

  • Systems Supervisor

    3 weeks ago

    Noblesville, United States Gaylor Full time

    OverviewOUR VISION. The HIGHEST PERFORMING NATIONAL CONTRACTOR OF EXCELLENCE, delivering on our Cornerstone of Reliable Resources, Outcomes, and Insights; dedicated to innovation, quality, and our genuine care for people. OUR VALUES . Integrity. Customer Service. Safety. Sales Growth. Teamwork. Return on Investment. Performance. Personnel Development. OUR...

  • Industrial Electrical Foreman

    6 months ago

    Noblesville, United States Gaylor Electric, Inc Full time

    Overview OUR VISION. The HIGHEST PERFORMING NATIONAL CONTRACTOR OF EXCELLENCE, delivering on our Cornerstone of Reliable Resources, Outcomes, and Insights; dedicated to innovation, quality, and our genuine care for people. OUR VALUES . Integrity. Customer Service. Safety. Sales Growth. Teamwork. Return on Investment. Performance. Personnel...

  • Systems Supervisor

    2 weeks ago

    Noblesville, United States Gaylor inc. Full time

    Job DescriptionJob DescriptionSystems SupervisorUS-IN-NoblesvilleJob ID: 2024-5568Type: Regular Full-Time# of Openings: 1Category: ElectriciansIndianapolis, INOverviewOUR VISION. The HIGHEST PERFORMING NATIONAL CONTRACTOR OF EXCELLENCE, delivering on our Cornerstone of Reliable Resources, Outcomes, and Insights; dedicated to innovation, quality, and our...

  • RN Clinical Supervisor

    3 weeks ago

    Noblesville, United States Community Rehabilitation Hospital West Full time

    Description We're offering a $15,000 Commitment Incentive Bonus to join our team at Community Rehabilitation Hospital West, a 40-bed acute rehabilitation hospital operated jointly with Lifepoint Health and Community Health System. As an RN Clinical Supervisor, you'll play a critical role in ensuring the provision of safe and effective patient care. We offer...

  • Electrical Design Specialist

    1 month ago

    Noblesville, Indiana, United States Gaylor inc. Full time

    Job SummaryAs a Design Engineer at Gaylor Electric Inc., you will be responsible for designing and engineering assigned projects, integrating technical designs with internal departments and external consultants, and reviewing completed design work for technical adequacy and project requirements.Key ResponsibilitiesDesign and plan electrical systems, develop...

  • Associate Procurement Program Manager

    3 weeks ago

    Noblesville, United States Trane Technologies Full time

    At Trane TechnologiesTM, we are seeking an Associate Procurement Program Manager for supplier relationship management responsibilities associated with Helmer Scientific temperature-controlled storage business and any other associated businesses. with the Life Science Solutions (LSS) business unit. As an Associate Procurement Program Manager, you will manage,...

  • Associate Procurement Program Manager

    3 weeks ago

    Noblesville, United States Trane Technologies Full time

    At Trane TechnologiesTM, we are seeking an Associate Procurement Program Manager for supplier relationship management responsibilities associated with Helmer Scientific temperature-controlled storage business and any other associated businesses. with the Life Science Solutions (LSS) business unit. As an Associate Procurement Program Manager, you will manage,...

  • Senior Construction Manager

    4 weeks ago

    Noblesville, United States Midas Building Group Full time

    At Midas Building Group, we're seeking a highly skilled Senior Construction Manager to lead our commercial construction projects to success.Key Responsibilities:Implement and enforce field safety protocols and reportingOversee quality assurance and identify potential issuesProduce RFIs, submittals, and change order requestsReview drawings and...

  • Design Engineer

    1 month ago

    Noblesville, IN, United States Gaylor inc. Full time

    Design EngineerUS-IN-NoblesvilleJob ID: Type: Regular Full-Time# of Openings: 4Category: EngineeringInnovation Indianapolis, INOverviewGAYLOR ELECTRIC INC. OUR VISION. The HIGHEST PERFORMING NATIONAL CONTRACTOR OF EXCELLENCE, delivering on our Cornerstone of Reliable Resources, Outcomes, and Insights; dedicated to innovation, quality, and our genuine care...

  • Laboratory Technician

    1 week ago

    Noblesville, United States AVD Workforce Connect Full time

    Location: Noblesville INJob Type: Full TimeMultiple openings per shift: 1st 2nd or 3rdJob Summary:This will be a fulltime direct placement position. Laboratory Technicians play a crucial role in the healthcare system by performing a wide range of diagnostic tests that are essential for detecting diagnosing and treating diseases. Working in medical...

  • Hotel Front Desk Representative

    4 weeks ago

    Noblesville, Indiana, United States Residence Inn Noblesville Full time

    Job SummaryWe are seeking a skilled and friendly Hotel Front Desk Representative to join our team at Residence Inn Noblesville. As a Night Auditor and Guest Services Associate, you will be responsible for ensuring a seamless and enjoyable experience for our guests.Key Responsibilities:Organize and process guest check-in/check-outs, verifying guest identity...

  • RN Endoscopy

    1 month ago

    Noblesville, United States Riverview Health Full time

    Job Summary Registered nurse in endoscopy setting provides continuity of individual patient care, safety, and education by direct assessment, planning, intervention, and evaluation of the nursing plan of care for the patient undergoing endoscopic procedures. Carry out responsibilities within the framework of the established standards of patient care in...

  • Nursing Director of Patient Care Development

    3 weeks ago

    Noblesville, Indiana, United States American Senior Communities Full time

    As a key member of our nursing leadership team, you will play a vital role in shaping the future of patient care at American Senior Communities.About the Role:We are seeking an experienced Nursing Director of Patient Care Development to join our team. In this critical role, you will be responsible for developing, communicating, and maintaining nursing...