Quality Assurance Specialist

2 weeks ago

Warren, United States Aequor Full time


Position: Quality - Specialist, QA Engineering 59748-1

Location: Warren NJ 07059

Duration: 12+ months (possibility of extension for the right candidate depending on performance)

Pay rate: $62/ hour on W2

100 % Onsite role, Warren NJ

Work Schedule: Monday - Friday, normal business Hours





Position Summa

ryThe Senior Specialist is responsible for supporting the Quality Engineering group from a Subject Matter Expert (SME) standpoint in accordance with the client's policies, standards, procedures, and Global cGMP. Functional responsibilities for the incumbent include facilitating Change Control Review Board (CCRB) and record tracking meetings (e.g. Change Actions weekly) as applicable, driving proactive and corrective improvements within Operations, providing support at all regulatory inspections and corporate audits, tracking internal/external audit commitments and driving on-time closure, evaluation of new requirements and emerging regulations, providing user support for the different Quality Systems as a site lead which includes integration activities and generation and review of Site Quality Metric


s.
Duties/Responsibilitie


s :
Ensure control of systems, processes, and products through the facilitation of C


CRB.
Represent site and provide impact assessment for global changes at Global


CCRB
Monitor and track external audit/inspection commitments to ensure timely cl


osure.
Track site change controls and ensure appropriate requirements are identified and completed for implemen


tation.
Provide weekly change control due date updates to the Tier board


metrics.
Must be skilled in planning and organizing, decision-making, and building relat


ionships.
Familiar with the Veeva Vault Q


MS system.
Able to effectively


multi-task.
Reporting


Relationship
Reports to Senior Manager, Q


A Engineering

QualificationsEDUCATION


AND EXPERIENCE
A B.S. degree is required, as well as a minimum of five years of experience in the pharmaceutical or re


lated industry.
Experience with cGMP manufacturing, Quality,


and compliance.
Excellent verbal and written comm


unication skills.
Thorough knowledge of and competence in quality processes, including material disposition, change control, product complaints, deviations, investigations, an


d CAPA management.
RE

QUIRED COMPETENCIESMust have advanced knowledge and experience with cGMP manufacturing, Quali


ty, and compliance.
Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe an


d compliant process.
Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a hi


gh level of accuracy.
Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across a majorit


y of the job function.
Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage the development of technical or scientific initiatives and activities by i


nterdisciplinary teams.
Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem-solving, conflict management, planning and organizing, resource allocation, coaching others,


and analytical thinking.
Must possess an independ


ent mindset and tenacity.
Requires moderate direction to complete more complex tasks; completes routine tasks with


little or no supervis


ion.
Work is self-directed.
Confident in making


decisions for minor issues.
Routinely recognizes Qualit


y issues and solves problems.
Proposes solutions for complex issues and works with management to resolve them. Follows established procedures


and performs work as assigned.
Intermediate to advanced ability to interpret results and situations and articulate


recommendations for resolution.
Is recognized Subject


Matter Expert within the group.
Provides guidance to other employees in th


e interpretation of complex data.
Capable of providing input within the department


and cross-functional teams. Build
relationships internally with


in and with cross-functional teams.
Contri


butes to goals within the workgroup.
Able to recognize conflict and notify management with pro


posed recommendations for resolution.
Able to prepare written communications and communicate problems to


management with clarity and accuracy.
Able to write and r


eview reports with clarity and brevity.
Able to effectively multi-tas


k and execute project management skills.
Know


ledge of US and global cGMP requirements.
Underst


anding of aseptic manufacturing processes.
Teamwork and ability to work effectively across functional group


s and teams to ensure requirements are met.
Ability to make independent and objective dec


isions and to work with minim

al supervision.
WORKING CONDITIONS: (US Only)Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no ab


normal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that


are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other

job-related duties as requested by management.

  • Quality Assurance Specialist

    2 weeks ago

    Warren, United States Lincoln Electric Full time

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

  • Quality Assurance Specialist

    5 days 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 weeks ago

    Warren, United States SPECTRAFORCE Full time

    Job DescriptionJob Title: Quality Assurance SpecialistJob Summary:SPECTRAFORCE is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and integrity of our products and services.Key Responsibilities:Ensure compliance with regulatory requirements and...

  • Quality Assurance Specialist

    4 weeks ago

    Warren, Michigan, United States Experis Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Experis. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our suppliers' products and services.Key ResponsibilitiesDevelop and implement quality assurance plans to ensure compliance with industry standards and regulations.Conduct...

  • Quality Assurance Specialist

    4 weeks ago

    Warren, United States Innova Solutions Full time

    About the RoleInnova Solutions is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our organization, you will play a critical role in ensuring the quality and integrity of our IT systems.Key ResponsibilitiesEnsure GMP Compliance: Develop and implement strategies to ensure that our IT systems meet Good Manufacturing...

  • Quality Assurance Specialist

    4 weeks ago

    Warren, 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 IT systems and processes.Key Responsibilities:Ensure accurate and timely maintenance of validation and qualification...

  • Quality Assurance Specialist

    1 month ago

    Warren, United States Cynet Systems Full time

    Job DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team at Cynet Systems.Job Summary:The Quality Assurance Specialist will be responsible for ensuring the quality and compliance of our products and services. This includes:Validating and qualifying equipment and facilities to ensure they meet regulatory...

  • Quality Assurance Specialist

    2 weeks ago

    Warren, 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 IT systems and processes.Key Responsibilities:Ensure accurate and timely maintenance of validation and qualification...

  • Quality Assurance Specialist

    2 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...

  • Quality Assurance Specialist

    4 weeks ago

    Warren, Michigan, United States Chili's Grill & Bar Full time

    Quality Assurance SpecialistAt Chili's Grill & Bar, we're committed to delivering exceptional Guest experiences. As a Quality Assurance Specialist, you'll play a vital role in ensuring our food meets the highest standards of quality and taste.Key Responsibilities:Monitor food preparation to ensure consistency and qualityCollaborate with kitchen staff to...

  • Quality Assurance Specialist

    4 weeks ago

    Warren, Michigan, United States TSR Consulting Services, Inc. Full time

    Job Title: Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at TSR Consulting Services, Inc. The successful candidate will be responsible for ensuring the quality and integrity of our IT systems, as well as reviewing and validating documentation for all equipment and facility activities.Key...

  • Quality Assurance Specialist

    3 weeks ago

    Warren, United States Qualis Corporation Full time

    Job DescriptionJob DescriptionQualis Corporation is seeking a Quality Assurance Specialist to provide support and expertise to one of our Army programs in Warren, Michigan.RequirementsRequirements:A Bachelors degree from an ABET accredited program in any general Engineering discipline from a college or university or a combination of Bachelors degree and...

  • Quality Assurance Specialist

    4 weeks ago

    Warren, Michigan, United States TSR Consulting Services, Inc. Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at TSR Consulting Services, Inc. as a Validation Engineer. This is a critical role that requires a strong background in quality assurance, regulatory compliance, and technical expertise.Key ResponsibilitiesEnsure accurate and timely maintenance of validation and...

  • Quality Assurance Specialist

    4 weeks ago

    Warren, United States Innova Solutions Full time

    Job Title: QA Engineering SpecialistInnova Solutions is seeking a highly skilled QA Engineering Specialist to join our team. As a QA Engineering Specialist, you will play a critical role in ensuring the quality and integrity of our IT systems, ensuring compliance with regulatory requirements and industry standards.Key Responsibilities:Ensure accurate and...

  • Quality Assurance Specialist

    1 month ago

    Warren, Maine, United States Joulé Full time

    Job SummaryWe are seeking a highly skilled and experienced Quality Assurance Specialist to join our dynamic team at Joulé. As a key member of our quality team, you will be responsible for ensuring that our suppliers consistently deliver high-quality components and materials that meet regulatory requirements and company standards.Key ResponsibilitiesDevelop...

  • Quality Assurance Specialist

    2 weeks ago

    Warren, United States Lincoln Electric Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Engineer to join our team at Lincoln Electric. As a Quality Assurance Engineer, you will play a critical role in ensuring the highest quality standards are met in our aerospace operations.Key ResponsibilitiesDevelop and implement quality management systems and processes to ensure compliance with...

  • Quality Assurance Specialist

    2 weeks ago

    Warren, United States Lincoln Electric Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Engineer to join our team at Lincoln Electric. As a Quality Assurance Engineer, you will play a critical role in ensuring the highest quality standards are met in our aerospace operations.Key ResponsibilitiesDevelop and implement quality management systems and processes to ensure compliance with...

  • Quality Assurance Specialist

    3 weeks ago

    Warren, United States Lincoln Electric Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Engineer to join our team at Lincoln Electric. As a Quality Assurance Engineer, you will play a critical role in ensuring the highest quality standards are met in our aerospace operations.Key ResponsibilitiesDevelop and implement quality management systems and processes to ensure compliance with...

  • Quality Assurance Specialist

    3 weeks ago

    Warren, United States Lincoln Electric Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Engineer to join our team at Lincoln Electric. As a Quality Assurance Engineer, you will play a critical role in ensuring the highest quality standards are met in our aerospace operations.Key ResponsibilitiesDevelop and implement quality management systems and processes to ensure compliance with...

  • Quality Assurance Specialist

    4 weeks ago

    Warren, Michigan, United States Acro Service Corp Full time

    Job Title: Supplier Quality EngineerAcro Service Corp is seeking a highly skilled Supplier Quality Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality standards are met in our supply chain.Key Responsibilities:Develop and implement quality plans for new component parts and...