Quality Assurance Associate II Specialist

4 days ago


Waltham, Massachusetts, United States Integrated Resources Full time

Job Overview

We are seeking a highly skilled Quality Assurance Associate II to join our team at Integrated Resources. This role is responsible for ensuring the quality and integrity of our products, from raw materials to finished goods.

About the Role

The ideal candidate will have a strong background in quality assurance, with a minimum of 5 years of experience in a manufacturing or QA/QC environment. They should possess excellent communication and interpersonal skills, as well as the ability to work effectively in a fast-paced team setting.

Key Responsibilities

  • Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents.
  • Perform QA review of Executed Batch Records.
  • Provide Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product, and clinical materials.
  • Ensure all requirements stipulated in the CMO Quality Agreements are being met.

Required Skills and Qualifications

To be successful in this role, you should have:

  • Bachelor's degree and/or 8+ years of relevant experience.
  • Minimum 5 years of experience in Quality Assurance.
  • Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards.
  • Demonstrated ability to interact and communicate effectively with peers, management, auditors, and consultants.

Salary

The salary range for this position is $44-$47 per hour, based on location and experience.



  • Waltham, Massachusetts, United States Mindlance Full time

    Job Description:We are seeking a highly skilled Quality Assurance Associate II to join our team at Mindlance. In this role, you will be responsible for ensuring the highest quality standards in our manufacturing processes.Main Responsibilities:Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated...


  • Waltham, Massachusetts, United States Boston Children's Hospital Full time

    Boston Children's Hospital is seeking a Medical Instrumentation Quality Assurance Specialist to join our team. As a key member of our Sterile Processing department, you will play a vital role in ensuring the accuracy and proper assembly of instrument trays.The ideal candidate will have 5+ years of experience in Sterile Processing and be certified in SPD,...


  • Waltham, Massachusetts, United States Goodwin Recruiting Full time

    Job OverviewWe are seeking a seasoned Quality Assurance Specialist to lead our manufacturing operations. This role will be responsible for overseeing daily processes, ensuring smooth and efficient business activities.


  • Waltham, Massachusetts, United States Pyramid Consulting Full time

    Job SummaryWe are seeking a skilled Senior Quality Assurance Specialist to join our team. This is a contract position located in Waltham, MA.Key Responsibilities:Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for timely GMP manufacturing activities initiation.Perform QA...


  • Waltham, Massachusetts, United States Boston Children's Hospital Full time

    Job SummaryThe Boston Children's Hospital seeks a skilled Sterile Processing Quality Assurance and Instrumentation Specialist to join their team. This role is responsible for ensuring the accuracy and proper assembly of instrument trays according to pick sheets.The successful candidate will verify instrument placement, check for good working order, and...


  • Waltham, Massachusetts, United States Mindlance Full time

    Quality Assurance Associate III**Job Summary**Mindlance is seeking a highly skilled Quality Assurance Associate III to join our team.**Key Responsibilities*** Review executed batch records and related documentation, resolve compliance issues, and dispose of lots of drug substance, bulk drug product, and clinical materials for use in clinical trials.* Perform...


  • Waltham, Massachusetts, United States Pyramid Consulting, Inc Full time

    About the RolePyramid Consulting, Inc. is currently seeking a Senior Quality Assurance Specialist to join our team in Waltham, MA. As a leading Healthcare Industry expert, we are looking for an experienced professional with 8+ years of relevant experience and minimum 5 years of experience in Quality.The ideal candidate will have a strong working knowledge...


  • Waltham, Massachusetts, United States Adecco US, Inc. Full time

    Company Overview: Adecco US, Inc. is a leading provider of human resources solutions. We are currently seeking a highly skilled Quality Assurance Associate to join our team in Waltham, MA.Job Summary: As a Quality Assurance Associate, you will be responsible for reviewing and approving Master Manufacturing Records, Stability Protocols and Reports, Sampling...


  • Waltham, Massachusetts, United States Integrated Resources Full time

    Job SummaryAs a Quality Assurance Associate III at Integrated Resources, you will be responsible for ensuring the quality and compliance of our products. This role is ideal for an individual with a strong background in quality assurance and a passion for ensuring the highest standards of quality.Key Responsibilities- Review and disposition lots of drug...


  • Waltham, Massachusetts, United States Pyramid Consulting, Inc Full time

    Position OverviewPyramid Consulting, Inc. is a leading provider of consulting services to the Healthcare Industry. We are currently seeking a Quality Assurance Associate III to join our team in Waltham, MA.The ideal candidate will have a Bachelor's degree and 8+ years of relevant experience, with a minimum of 5 years of experience in Quality.This is a...


  • Waltham, Massachusetts, United States Mindlance Full time

    Job OverviewMindlance seeks a seasoned Quality Assurance Associate to join our team. As a key member of our Quality Department, you will play a critical role in ensuring the highest standards of quality and compliance.Key Responsibilities:Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated...


  • Waltham, Massachusetts, United States Boston Children's Hospital Full time

    OverviewBoston Children's Hospital is seeking a skilled Sterile Processing Quality Assurance Operations Specialist to join our team.


  • Waltham, Massachusetts, United States Adobe Full time

    ​Job Summary:Adobe is seeking a Quality Assurance and Test Engineering Specialist to join our team. As a key member of our product and infrastructure team, you will assist with the construction and testing of the Sign Application foundation using state-of-art cloud technologies, including AWS and Azure.Key Responsibilities:Support and develop...


  • Waltham, Massachusetts, United States eTeam Full time

    Documentation Specialist IIAre you a detail-oriented professional with experience in documentation management?eTeam is seeking a Documentation Specialist II to join our team. As a key member of our Documentation team, you will be responsible for managing Veeva documentation, tracking third-party events, and providing support to our quality systems...


  • Waltham, Massachusetts, United States Mindlance Full time

    About the RoleWe are seeking a highly skilled Quality Compliance Specialist to join our team at Mindlance. In this critical role, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing operations.Responsibilities:Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling...


  • Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    OverviewDeciphera Pharmaceuticals, a member of ONO, is a biopharmaceutical company dedicated to developing innovative medicines for cancer treatment. With a focus on switch-control kinase inhibitors and a deep understanding of kinase biology, the company has established a robust pipeline of wholly-owned drug candidates.Salary$180,000 - $220,000 per year,...


  • Waltham, Massachusetts, United States Lifelancer Full time

    Revolutionize Cancer Treatment as a Senior Quality Assurance ExecutiveJob Title: Senior Quality Assurance ExecutiveLocation: Waltham, MA or New York CityEstimated Salary:$200,000 - $250,000 per annumAbout the RoleSyndax Pharmaceuticals is seeking an exceptional Senior Quality Assurance Executive to spearhead its commercial-stage quality organization. This...


  • Waltham, Massachusetts, United States Diverse Lynx Full time

    OverviewDiverse Lynx LLC is an Equal Employment Opportunity employer. We promote and support a diverse workforce across all levels in the company.Salary and BenefitsThe estimated salary for this role is $80,000 per year. As an employee of Diverse Lynx LLC, you will receive comprehensive benefits, including health insurance, retirement plans, and paid time...


  • Waltham, Massachusetts, United States RPM ReSearch Full time

    RPM ReSearch is seeking a highly experienced and skilled Quality Assurance Director to lead our Quality Operations Group (QOG). The ideal candidate will have at least 8 years of experience in a quality leadership position within the biological and/or pharmaceutical industry. This role requires a strong knowledge of FDA and EMA regulatory requirements, as...


  • Waltham, Massachusetts, United States Lifelancer Full time

    Job Title: Biologics Quality Assurance ManagerWe are seeking a Biologics Quality Assurance Manager at Lifelancer, a talent-hiring platform in Life Sciences, Pharma, and IT.Estimated Salary: $100,000 - $160,000 per year.About the CompanyMural Oncology is a clinical-stage oncology business focused on discovering and developing immunotherapies that may...