Current jobs related to Quality Compliance Specialist Ii - Lexington - ARIAD

  • Quality Assurance Specialist II

    22 hours ago

    Lexington, Massachusetts, United States Genezen Full time

    Job DescriptionGenezen is a leading biotechnology company dedicated to advancing gene therapy and cell therapy clinical trials. We are seeking a highly skilled Quality Assurance Specialist II to join our team in Fishers, Indiana or Lexington, Massachusetts.About the RoleThe Quality Assurance Specialist II will play a critical role in supporting the...

  • Coding Specialist II

    2 weeks ago

    Lexington, Kentucky, United States CommonSpirit Health Full time

    Job SummaryWe are seeking a skilled Coding Specialist II to join our team at CommonSpirit Health. As a Coding Specialist II, you will play a critical role in ensuring the accuracy and compliance of our medical coding practices.Key ResponsibilitiesAbstract information from service documentation and assign appropriate CPT, ICD-9/10, and HCPCS codes into the...

  • Procurement Specialist II

    2 weeks ago

    Lexington, Kentucky, United States Spiral Solutions and Technologies Full time

    About the Role:Spiral Solutions and Technologies is seeking a skilled Procurement Specialist II to join our team. As a key member of our procurement department, you will be responsible for managing subcontracting activities, ensuring compliance with industry standards and regulations.Key Responsibilities:Subcontract Administration: Develop and implement...

  • Agriculture Compliance Specialist

    7 days ago

    Lexington, Kentucky, United States GeorgiaGov Full time

    Job SummaryWe are seeking a highly skilled Agriculture Compliance Specialist to join our team at the Georgia Department of Agriculture. As a key member of our Retail Food Section, you will play a critical role in protecting consumers' health by ensuring that food in Georgia is prepared in a clean environment and honestly presented.Key ResponsibilitiesConduct...

  • Agriculture Compliance Specialist

    2 weeks ago

    Lexington, Kentucky, United States GeorgiaGov Full time

    Job SummaryThis position is part of the Georgia Department of Agriculture's Retail Food Section, responsible for ensuring food safety and compliance with state and federal regulations.Key ResponsibilitiesConduct inspections and investigations of retail food stores, bakeries, seafood operations, and mobile meat trucks to ensure compliance with health and...

  • Quality Assurance Specialist II

    5 days ago

    Lexington, United States Genezen Full time

    Job DescriptionJob DescriptionThe field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZENMany...

  • Compliance Specialist

    3 weeks ago

    Lexington, Kentucky, United States Commonwealth of Virginia Full time

    Job SummaryThe Commonwealth of Virginia seeks a highly skilled and compassionate Compliance Specialist to serve as the initial point of contact for individuals seeking assistance, reporting concerns, or filing complaints related to compliance matters, including Title IX issues.Key Responsibilities:Serve as the first point of contact for individuals seeking...

  • Environmental Compliance Specialist

    2 weeks ago

    Lexington, Virginia, United States Environmental Consultants (ECI) Full time

    Job SummaryWe are seeking a highly skilled Environmental Compliance Specialist to join our team at Environmental Consultants (ECI). As an Environmental Compliance Specialist, you will be responsible for ensuring compliance with laws and regulations related to environmental protection, particularly in the context of linear utility site work construction.Key...

  • Agriculture Compliance Specialist 1

    3 weeks ago

    Lexington, Kentucky, United States GeorgiaGov Full time

    Job SummaryThis position is part of the Georgia Department of Agriculture's (GDA) Retail Food Section within the Food Safety Division. The Food Safety Division is responsible for protecting consumers' health by ensuring that food in Georgia is prepared in a clean environment and honestly presented.Key ResponsibilitiesAssist with the implementation of...

  • Quality Assurance Specialist II

    1 month ago

    Lexington, United States Genezen Full time

    Job DescriptionJob DescriptionThe field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZENMany...

  • Code Compliance Specialist

    2 weeks ago

    Lexington, South Carolina, United States Bunnell-Lammons Engineering, Inc Full time

    Job OverviewBunnell-Lammons Engineering, Inc. is seeking a highly skilled Code Compliance Specialist to provide expert building code compliance inspections for a wide range of projects.Key ResponsibilitiesConduct thorough inspections of commercial, institutional, industrial, and residential buildings to ensure compliance with applicable codes and project...

  • Quality Assurance Specialist II

    4 weeks ago

    Lexington, Kentucky, United States Randstad Life Sciences US Full time

    Contract PositionLocation: Lexington, MAPay Rate: $48-53/hrPosition OverviewThe primary responsibilities of this role will concentrate on the daily laboratory functions and the execution of assessments to support manufacturing processes, validation, or developmental studies. Testing may encompass, but is not limited to, samples from drug substance and drug...

  • Sr. Contract Compliance Specialist

    1 month ago

    Lexington, United States The Ladders Full time

    Job SummarySr. Contract Compliance Specialist The Sr. Contract Compliance Specialist (Sr. Specialist) is a highly specialized role responsible for managing a targeted portfolio of complex, high-value goods and services contracts. The Sr. Specialist will collaborate with Contract Management, Sales, Merchandising, Finance, Distribution, and Galls' Legal...

  • Senior Compliance Auditor

    4 weeks ago

    Lexington, Kentucky, United States Addiction Recovery Care Full time

    Position OverviewAre you seeking a fulfilling career in a supportive environment? Addiction Recovery Care, LLC (ARC) has been recognized as one of the top workplaces in Kentucky, reflecting our commitment to employee satisfaction.At ARC, we are dedicated to our mission of providing exceptional care and support to our clients, patients, and team members. As...

  • Director of Quality Assurance and Compliance

    2 weeks ago

    Lexington, Kentucky, United States GQR Full time

    About the RoleWe are seeking an experienced Associate Director, GCP Quality Assurance to join our team at GQR. This is a hybrid role that requires a true Clinical Quality professional with a strong background in Good Clinical Practice (GCP) and clinical trials.Key ResponsibilitiesQuality Event Management: Advanced knowledge in the management of quality...

  • Electromechanical Assembly Specialist II

    4 weeks ago

    Lexington, Kentucky, United States T2 Biosystems Full time

    Position OverviewThe Electromechanical Assembly Specialist II will work under the guidance of the Director of Instrument and Cartridge Manufacturing. This role is integral to the assembly and construction of our advanced benchtop instruments.Key ResponsibilitiesParticipate in all aspects of manufacturing operations, including the assembly and testing of...

  • Quality Assurance Analyst II

    4 weeks ago

    Lexington, Kentucky, United States Genezen Full time

    Job OverviewThe field of gene therapy is expanding swiftly, and Genezen is committed to fulfilling the precise requirements of our clients. We specialize in process development, the production of GMP viral vectors, and cell transduction for gene and cell therapy clinical trials, playing a vital role in the journey towards new cures.WORKING AT GENEZENMany...

  • Construction Compliance Specialist

    2 weeks ago

    Lexington, Kentucky, United States Softworld, a Kelly Company Full time

    Job SummarySoftworld, a Kelly Company is seeking a highly skilled Construction Compliance Specialist to oversee the construction and renovation of Sensitive Compartmented Information Facilities (SCIFs) and Special Access Program Facilities (SAPFs) to ensure adherence to all government security regulations.Key ResponsibilitiesProject Management: Oversee the...

  • Aircraft Quality Control Specialist

    4 weeks ago

    Lexington, Oklahoma, United States Amentum Full time

    Job SummaryAmentum is seeking a highly skilled Aircraft Quality Control Specialist to join our team. As an Aircraft Quality Control Specialist, you will be responsible for ensuring the quality and safety of aircraft structures, structural components, and engines.Key ResponsibilitiesInspect and Evaluate Aircraft Components: Conduct thorough inspections of...

  • Senior Compliance Auditor

    4 weeks ago

    Lexington, Kentucky, United States Addiction Recovery Care Full time

    Position OverviewAre you eager to contribute to a workplace recognized for its excellence? Addiction Recovery Care, LLC (ARC) has been acknowledged as one of the premier employers in Kentucky, reflecting the positive feedback from our dedicated staff.We are committed to fostering an environment driven by shared objectives and a passion for enhancing the...

Quality Compliance Specialist Ii

3 months ago

Lexington, United States ARIAD Full time

At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.

**Job ID** R0121657**Date posted** 04/25/2024**Location** Lexington, Massachusetts**Job Title**: Quality Compliance Specialist II

**Location**: Lexington, MA

**About the role**:
You will be responsible for all quality improvement issues related to vendors and suppliers of materials, products and services. You will execute the global Supplier Quality and Material Management programs at the MA Bio Ops plant, and support local team members and stakeholders in the Biologics OpU on matters pertaining to supplier controls, significant concerns related to Quality System performance, risk-based audit execution, issue escalation, procurement strategy and regulatory compliance.

This is a hybrid position that reports to the Manager, Supplier Quality and Auditing.

**How you will contribute**:

- Lead Supplier Notifications of Change (SNC) process
- Co-audit internal or external quality systems and supplier questionnaires
- Coordinate with suppliers and MA Bio Ops supply chain teams to resolve nonconforming raw material (RMNCMR) issues
- Perform Change Control SQ tasks due to technical transfers and necessary product/material specification changes
- Undertake supporting role in regulatory inspections, as needed
- Support New Supplier Request (NSR) workflows and Trackwise record updates
- Material Qualification Report reviews
- Support regulatory document requests

**What you bring to Takeda**:

- Bachelor's Degree in a Scientific Discipline
- 2+ Years experience leading cross functional teams in a life sciences environment
- 1+ years of experience with Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) including global cGMP regulations (US, EU, Japan, Canada) desirable
- 1+ years of experience working with regulatory agencies and/or direct interface experience with regulatory agencies during inspections desirable

**Important Considerations**:
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

- May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

**More about us**:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

GMSGQ #ZR1 #LI-MA1 #LI-Hybrid

**Takeda Compensation and Benefits Summary**

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

**For Location**:
USA - MA - Lexington - BIO OPS
- ** U.S. Base Salary Range**:
$67,900.00 - $106,700.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan