Quality - QA Specialist

1 month ago

Warren, United States Omni Inclusive Full time

PURPOSE AND SCOPE OF POSITION:
Specialist, QA Operations, is responsible for quality oversight of Cell Therapy Development Operations (CTDO) activities in accordance with Client policies, standards, procedures, and Global cGMP requirements. This position reports to the Senior Manager of Quality Assurance Operations.

Functional responsibilities include On-Site coverage of and/or participation in:
• QA Shop Floor and Warehouse/Storage Area Walkthrough activities
• Label Printing and Issuance of finished drug product and shipping labels
• Event Triage
• Packout oversight and performance of release-to-market
• Ensuring accurate and timely review, as well as maintaining, clinical manufacturing GMP/batch related
documentation and procedures.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• BS/MS in a related scientific discipline.
• Minimum 4 years of experience within QA functions in the pharmaceutical industry.
• Thorough knowledge of cGMP in the pharmaceutical industry. Good understanding of the drug development
process.
• Knowledge and application experience with batch record review, product disposition/release, change control,
SOP review, GMP inspection.
• Good computer skills and working knowledge of common business software.
• Excellent organizational skills.
• Excellent problem-solving, verbal, and written communication skills.
• Must have strong interpersonal and communication skills, be a team player.
• Must be an individual with proven initiative and demonstrated accountability.
• Professional integrity and maturity are required.

DUTIES AND RESPONSIBILITIES:
• Provide Functional QA Oversight of Warren Manufacturing Operations, Supply Chain Operations, Warehouse,
QA and QC Laboratory processes in the execution of Clinical Manufacturing of Cell Therapy Products
• Participate in Shop Floor and Quality Check Walkthrough programs.
• Printing, Issuance, Chain of Identify (COI) verification, and Reconciliation of finished drug product labels used by
Manufacturing and Supply Chain Operations.
• Apply knowledge of quality processes, including batch record review, material disposition, triaging of deviations,
investigations, CAPA, risk management, change control, and product complaints.
• Revise department SOPs, as well as Review and QA Approval of CTDO SOPs
• Perform Real time review /approval of executed batch records and Chain of Identity verification.
• Responsible for ERP Material Status Changes of production/drug product
• Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and
requirements.
• Supports Risk Assessments/projects as required by senior management.

EDUCATION AND EXPERIENCE:
• B.S. scientific discipline or relevant college/ university degree preferred.
• Equivalent combination of education and experience acceptable.
• Strong knowledge of cGMP Quality and Compliance principles required.
• Clinical and Phase appropriate experience preferred.
• Strong cross-functional collaboration experience required.

  • QA Shop Floor Specialist

    4 weeks ago

    Warren, United States ASK Consulting Full time

    "All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".Job Title: QA Shop Floor SpecialistDuration: 6 MonthsLocation: Warren NJPay: $32- $35.34Job Description:Purpose And Scope Of Position:Specialist, QA Operations, is responsible for quality oversight...

  • QA Shop Floor Specialist

    4 weeks ago

    Warren, United States ASK Consulting Full time

    "All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".Job Title: QA Shop Floor SpecialistDuration: 6 MonthsLocation: Warren NJPay: $32- $35.34Job Description:Purpose And Scope Of Position:Specialist, QA Operations, is responsible for quality oversight...

  • Quality - Specialist, QA Engineering

    4 weeks ago

    Warren, United States Futran Tech Solutions Pvt. Ltd. Full time

    Job Description: 100 % Onsite role, Warren NJ Work Schedule: Monday - Friday, normal business Hours Position Summary The Senior Specialist is responsible for supporting the Quality Engineering group from a Subject Matter Expert (SME) standpoint in accordance with BMS policies, standards, procedures, and Global cGMP. Functional responsibilities for the...

  • QA Engineering Specialist

    4 weeks ago

    Warren, United States LanceSoft Full time

    Title: Specialist, QA Engineering Location: Warren NJ, 07059 Duration: 12 monthsJob Description: 100 % Onsite role, Warren NJ Bachelor's Degree is requiredWork Schedule: Monday - Friday, normal business HoursPosition Summary The Senior Specialist is responsible for supporting the Quality Engineering group from a Subject Matter Expert (SME) standpoint in...

  • Specialist, QA Engineering

    4 weeks ago

    Warren, United States American Cybersystems Full time

    Innova Solutions has a client that is immediately hiring for a Quality Assurance Engineering Specialist, Position type: Full-time Contract Duration: 12 months Location: Warren, NJ As a Quality Assurance Engineering Specialist, you will: The Senior Specialist is responsible for supporting the Quality Engineering group from a Subject Matter Expert (SME)...

  • Specialist, QA Engineering

    1 month ago

    Warren, United States Surnise Systems inc Full time

    Job Title: Specialist, QA Engineering Job ID: 24-04369 Location: Warren, NJ, 07059 Duration: 12 Months contract on W2 100 % Onsite role, Warren NJ Work Schedule: Monday - Friday, normal business Hours Position Summary The Senior Specialist is responsible for supporting the Quality Engineering group from a Subject Matter Expert (SME) standpoint...

  • Quality Assurance Specialist

    4 weeks ago

    Warren, Michigan, United States Innova Solutions Full time

    Job Title: Quality Assurance SpecialistInnova Solutions is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products and services.Key Responsibilities:Ensure accurate and timely maintenance of validation and qualification...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Warren, United States Synectics Inc Full time

    Job Title: QA Engineering SpecialistJob SummaryWe are seeking a highly skilled QA Engineering Specialist to join our team at Synectics Inc. The successful candidate will be responsible for supporting the Quality Engineering group as a Subject Matter Expert, ensuring compliance with policies, standards, procedures, and Global cGMP.Key...

  • Vehicle Infotainment IT QA Test Specialist

    1 month ago

    Warren, Michigan, United States Tech Tammina Full time

    Job Title: Vehicle Infotainment IT QA Test AnalystJoin Tech Tammina LLC as a skilled Vehicle Infotainment IT QA Test Analyst and contribute to the development of cutting-edge automotive technology.Role OverviewAs a Vehicle Infotainment IT QA Test Analyst, you will be responsible for testing and validating the integration of vehicle data with GM internal...

  • IT Quality Assurance Specialist

    2 weeks ago

    Warren, United States Tech Tammina Full time

    Job Title: IT QA Test Analyst 2-UAT positionJob Summary: Tech Tammina is seeking a highly skilled IT QA Test Analyst 2-UAT position to join our team. As a key member of our quality assurance team, you will be responsible for leading UAT test case design, review, execution, and defect management. You will also provide daily support and direction for a team of...

  • QA Engineer

    4 weeks ago

    Warren, United States Axelon Services Corporation Full time

    100 % Onsite role Warren NJ Work Schedule: Monday - Friday Position Summary The Senior Specialist is responsible for supporting the Quality Engineering group from a Subject Matter Expert (SME) standpoint in accordance with Client policies, standards, procedures, and Global cGMP. Functional...

  • QA Engineer

    3 weeks ago

    Warren, United States Axelon Services Corporation Full time

    100 % Onsite role Warren NJPay : 60$/hr - 64$/hrWork Schedule: Monday - FridayPosition SummaryThe Senior Specialist is responsible for supporting the Quality Engineering group from a Subject Matter Expert (SME) standpoint in accordance with Client policies, standards, procedures, and Global cGMP.Functional responsibilities for the incumbent include...

  • Vehicle Infotainment IT QA Test Specialist

    3 weeks ago

    Warren, United States Tech Tammina Full time

    Job Summary: Tech Tammina LLC is seeking a skilled Vehicle Infotainment IT QA Test Analyst to join our team. As a key member of our team, you will be responsible for testing and ensuring the quality of our infotainment systems for vehicles.Key Responsibilities: Execute test plans, scenarios, and scripts to ensure the quality of our infotainment systems. Test...

  • Quality Assurance Specialist

    4 weeks ago

    Warren, United States CIRCOR International Full time

    Job Title: Quality TechnicianAt CIRCOR International, we are seeking a highly skilled Quality Technician to join our team. As a Quality Technician, you will play a critical role in ensuring the quality of our products and services.Key Responsibilities:Perform quality assurance processes to support customer order requirementsReview certifications, prepare...

  • Vehicle Infotainment IT Quality Assurance Specialist

    2 weeks ago

    Warren, United States Tech Tammina Full time

    Job Title: Vehicle Infotainment IT QA Test AnalystJob Summary: Tech Tammina LLC is seeking a skilled Vehicle Infotainment IT QA Test Analyst to join our team. As a key member of our team, you will be responsible for testing and validating the functionality of vehicle infotainment systems, ensuring that they meet the required standards and specifications.Key...

  • Quality Assurance Specialist

    4 weeks ago

    warren, United States Aequor Full time

    Position: Quality - Specialist, QA Engineering 59748-1Location: Warren NJ 07059Duration: 12+ months (possibility of extension for the right candidate depending on performance)Pay rate: $62/ hour on W2 100 % Onsite role, Warren NJWork Schedule: Monday - Friday, normal business HoursPosition SummaryThe Senior Specialist is responsible for supporting the...

  • Quality Assurance Specialist

    5 days ago

    Warren, Michigan, United States MSIG Holdings USA, Inc. Full time

    Job SummaryThe Quality Assurance Analyst will be responsible for planning and executing system functional testing, related data analysis, and user acceptance testing coordination and support. This role will work closely with the QA Team Lead, project manager, or IT manager to ensure the successful implementation of system enhancements and functional...

  • Quality Assurance Specialist

    2 weeks ago

    Warren, United States Lincoln Electric Full time

    Job SummaryLincoln Electric is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the highest quality standards are met in our aerospace operations.You will work closely with our quality management team to develop and implement quality assurance processes and...

  • Quality Assurance Specialist

    3 weeks ago

    Warren, United States Baker Industries, Inc Full time

    Job Title: Quality Assurance SpecialistBaker Industries, Inc is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the highest quality standards are met in our aerospace operations.Key Responsibilities:Document and report product or service quality levelsDevelop...

  • Quality Assurance Specialist

    4 days ago

    Warren, Michigan, United States Lincoln Electric Full time

    Job Summary:Lincoln Electric is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the highest quality standards are met in our aerospace operations.Key Responsibilities:Document and report product or service quality levelsDevelop and implement quality...