Senior Quality

4 weeks ago

Raleigh, North Carolina, United States Merz North America Full time

The Sr. Quality / Document Control Associate is responsible for providing support of R&D Quality activities as related to R&D Quality data and documentation surveillance. Additionally, this position will operate as a liaison among the various Quality areas, R&D functions, and Merz Quality entities coordinating on trend analysis. This position works with minimal supervision & requires a very high degree of interaction with other cross functional departments.

Responsibilities
  • Quality System Document Management:

    • Generating and/or revising procedural documents and active participation in the SOP Committee.

    • Processing of all document types and, including Document Change Notices, Marketing Materials, Manufacturing Support documents, Facilities Maintenance documents, Change Requests, Protocols and Reports, etc. through the review/approval process, uploading attachments if needed, and ensuring final document meets the standards for Document Control before release.

    • Perform SAP transactions governing specification documents.

    • Liaise with Business Operations regarding procedural document training and associated competency quizzes.

    • Provide training on the QMS & Document Management to Ax R&D staff as needed.
  • Quality Data Surveillance Management:

    • Responsible for the management of Ax R&D Quality data surveillance to include the maintenance of outcomes and documentation for audits, inspections, issue management, procedural documentation, and overall data and documentation for all areas of quality.

    • Effectively manage data analytics as defined by department, and corporate objectives.

    • Analyze and present cross functionality on quality outcomes to support decision-making.

    • Effectively manage project timelines as defined by department, project team, and corporate objectives.

    • Produce R&D Quality data metrics to support the Quality Data Report and Global Quality Council

    • Develop and implement strategies and systems for data analyses, data collection systems, and other strategies that optimize statistical efficiency and quality.

    • Identify, analyze, and interpret trends or patterns in complex data sets as it pertains to Ax R&D.
  • Inquiry Management:

    • Responsible for the management of all inquiries received in Ax R&D Quality

    • Provide updates to R&D Quality staff, as applicable.

    • Development and implement data analyses, data collection systems and other strategies that optimize statistical efficiency and quality as it pertains to inquiry management.
  • Vendor Qualification:

    • Responsible for the management of vendor qualification surveillance activities. Specifically, manage the triage and scheduling of vendor qualifications, manage the global vendor qualification list and vendor qualification questionnaires for all vendors.

    • Ensuring all vendor qualifications are current.

    • Escalate qualification noncompliance as needed
  • General Quality Support:

    • Provide support for R&D related audits and inspections, both internal and external

    • Provide support for approval of R&D vendors/suppliers.

    • Provide support for R&D related SOP creation and maintenance.

    • Provide support for R&D related Issue Management, including the ownership of NCRs and Action Items

    • Assist in ensuring applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to applicable regulations (ISO, Ministries of Health (FDA, EMA, Health Canada, TGA, ANVISA, etc.)).
  • Quality Improvements:

    • Engage with and promote harmonization initiatives within the R&D group.

    • Engage with and promote projects to improve R&D compliance and operational efficiencies.
  • Quality Intelligence:

    • Stay informed of the latest updates related to applicable regulations to ensure R&D Quality policies and procedures remain compliant.

    • Provide updates to R&D staff, as applicable.
  • Further Tasks:

    • Communicate effectively cross-functionally and raise questions/issues to the attention of executive management, as appropriate.

    • Provide support to other R&D staff as needed and perform duties and assignments as required.
  • Other duties as assigned:

    • Additional duties as needed to support the business and overall company objective
Technical Skill:
  • Initiative and a willingness to go above and beyond expectations
  • Strong sense of drive, initiative, and self-motivation
  • Demonstrated proactive approach to the management and oversight of assigned tasks and projects to drive them to successful completion.
  • Demonstrated organizational skills, ability to independently prioritize work and detail oriented
  • Effectively manage project timelines as defined by department, project team, and corporate objectives.
  • Proficient in all MS Office applications
  • Strong verbal and written communication skills
  • Ability to effectively multitask and manage multiple projects
  • Knowledge of regulatory requirements and standards (i.e. GCP, GMP, GLP, Data Integrity)
  • Ability to work effectively in a global, matrix environment
  • Ability to travel up to 20%
Minimum Qualifications
  • Bachelor's Degree or equivalent experience that demonstrates the ability to perform the duties of this position.
  • Minimum 3-4 years relevant Quality document management, data management, and/or analysis experience
  • Minimum of 2 years experience with Master Control Quality Management System
  • Proficient in all MS Office applications
  • Demonstrated organizational skills, ability to independently prioritize work and detail oriented.
  • Strong verbal and written communication skills
  • Ability to effectively multitask and manage multiple projects
Preferred Qualifications
  • Certification(s) – ASQ Quality Assurance

  • Caregiver - Senior Living Assistant

    3 days ago

    Raleigh, North Carolina, United States Sunrise Senior Living Full time

    About the RoleWe are seeking a compassionate and dedicated Care Manager to join our team at Sunrise Senior Living. As a Care Manager, you will play a vital role in providing high-quality care and services to our residents and their families.ResponsibilitiesBuild meaningful relationships with residents and their families, providing assistance with activities...

  • Lead Caregiver

    1 day ago

    Raleigh, North Carolina, United States Sunrise Senior Living Full time

    About the RoleSunrise Senior Living is seeking a highly skilled and compassionate Lead Caregiver to join our team. As a Lead Caregiver, you will play a vital role in ensuring the highest quality of care and services are provided to our residents.Key ResponsibilitiesProvide supervisory support to Care Managers, ensuring attendance, managing call-offs, and...

  • Caregiver - Senior Living Assistant

    24 hours ago

    Raleigh, North Carolina, United States Sunrise Senior Living Full time

    About the RoleWe are seeking a compassionate and dedicated Care Manager to join our team at Sunrise Senior Living. As a Care Manager, you will play a vital role in providing exceptional care and services to our residents and their families.ResponsibilitiesBuild meaningful relationships with residents and their families, providing assistance with activities...

  • Senior Quality Assurance Leader

    2 weeks ago

    Raleigh, North Carolina, United States Verbatim Pharma Full time

    Senior Quality Assurance Leader - Verbatim PharmaAre you looking for an organization that empowers you with the creativity and autonomy to lead a Quality Assurance team while contributing to the establishment of a new facility?Your position will encompass strategic and operational responsibilities, challenging your leadership skills. Daily, you will utilize...

  • Receptionist for Senior Living

    1 week ago

    Raleigh, North Carolina, United States Kisco Senior Living Full time

    Position Overview:The Customer Service Associate at Kisco Senior Living plays a vital role in ensuring a welcoming and secure environment for residents and visitors alike.**We are seeking an individual available for evening shifts during the week and morning shifts on weekends as needed**Compensation: $15.50/hourKey Responsibilities:Monitor the entry and...

  • Caregiver - Senior Living Assistant

    1 day ago

    Raleigh, North Carolina, United States Sunrise Senior Living Full time

    About the RoleSunrise Senior Living is seeking a dedicated and compassionate Caregiver to join our team. As a Caregiver, you will play a vital role in providing exceptional care and services to our residents, ensuring their physical, emotional, and social needs are met.Key ResponsibilitiesBuild Meaningful Relationships: Develop strong bonds with residents...

  • Senior Quality Assurance Analyst

    2 weeks ago

    Raleigh, North Carolina, United States Coastal Credit Union Full time

    Job OverviewPosition Title: Senior Quality Assurance AnalystLocation: HybridYour Contribution:As a Senior Quality Assurance Analyst, you will leverage your meticulous attention to detail and analytical skills to ensure that loan processes adhere to the established guidelines, policies, and regulatory standards of the Credit Union. Your role will involve...

  • Senior Living Sales Consultant

    2 weeks ago

    Raleigh, North Carolina, United States Treeo Senior Living Full time

    Join Our Team at Treeo Senior LivingAt Treeo Senior Living, we pride ourselves on providing exceptional hospitality-driven care services. Our dedicated team members are essential in creating a warm and welcoming environment for our residents and their families. Together, we strive to enhance the quality of life for older adults through outstanding dining...

  • Senior Quality Assurance Tester

    21 hours ago

    Raleigh, North Carolina, United States Focused HR Solutions Full time

    Job DescriptionWe are seeking a highly skilled Senior Quality Assurance Tester to join our team at Focused HR Solutions. As a key member of our QA team, you will be responsible for ensuring the highest quality of our web applications.Key Responsibilities:Conduct thorough testing of web applications to identify defects and issues.Develop and execute test...

  • Senior Quality Assurance Tester

    45 minutes ago

    Raleigh, North Carolina, United States Focused HR Solutions Full time

    Job DescriptionWe are seeking a highly skilled Senior Quality Assurance Tester to join our team at Focused HR Solutions. As a key member of our QA team, you will be responsible for ensuring the highest quality of our web applications.Key Responsibilities:Conduct thorough testing of web applications to identify defects and issues.Develop and execute test...

  • Senior IT Quality Assurance Analyst

    1 week ago

    Raleigh, North Carolina, United States Connvertex Technologies Inc. Full time

    Position OverviewThis role is fully remote.The Senior IT Quality Assurance Analyst plays a crucial role in ensuring the reliability and performance of software applications through comprehensive testing methodologies.Key ResponsibilitiesConducting load, stress, and performance assessments for various software solutions.Reviewing and comprehending all...

  • Senior IT Quality Assurance Tester

    2 weeks ago

    Raleigh, North Carolina, United States Serigor Inc Full time

    Job Title: IT Senior Tester (HYBRID) Location: Remote Duration: Long-term Contract Job Overview: Serigor Inc is in search of an IT Senior Tester to execute Quality Assurance and Testing activities for the Manufacturing Execution System (MES) modules. Key Responsibilities: Evaluate the testability of specifications and create test cases derived from Business...

  • Executive Director

    7 days ago

    Raleigh, North Carolina, United States Capital Senior Living Full time

    Executive Director OpportunityWe are seeking an experienced Executive Director to lead our team at Capital Senior Living. As a key member of our management team, you will be responsible for overseeing the financial, human resource, and operations management of our community.About the RoleLead the community as the primary point of contact for residents,...

  • Senior Patient Support Quality Manager

    1 week ago

    Raleigh, North Carolina, United States Piper Companies Full time

    Piper Companies is currently seeking a Patient Support Quality Manager to join their team in a hybrid role. The Senior Patient Support Quality Manager will be responsible for ensuring high standards of quality and efficiency in patient support.Key Responsibilities:Monitor the performance of patient engagement quality programs through the use of KPIs and...

  • Senior Manager, IT Quality Assurance

    2 weeks ago

    Raleigh, North Carolina, United States GILEAD Sciences Full time

    About Gilead Sciences Inc.Gilead Sciences Inc. is committed to fostering a healthier world for everyone. With a longstanding focus on tackling diseases such as HIV, viral hepatitis, COVID-19, and cancer, we have dedicated over 35 years to developing innovative therapies that improve lives and ensure global access to these essential treatments. Our mission to...

  • Senior Manager, IT Quality Assurance

    2 weeks ago

    Raleigh, North Carolina, United States GILEAD Sciences Full time

    About Gilead Sciences Inc.Gilead Sciences Inc. is committed to fostering a healthier global community. With a legacy of over 35 years in addressing critical health issues such as HIV, viral hepatitis, COVID-19, and cancer, we focus on developing pioneering therapies that improve lives and ensure worldwide access to these essential treatments. Our dedication...

  • Senior Manager, IT Quality Assurance

    1 week ago

    Raleigh, North Carolina, United States GILEAD Sciences Full time

    About Gilead Sciences Inc.Gilead Sciences Inc. is committed to fostering a healthier world for all individuals. With a longstanding focus on addressing diseases such as HIV, viral hepatitis, COVID-19, and cancer, we have dedicated over 35 years to developing innovative therapies that improve lives and ensure global access to these vital treatments. Our...

  • Senior Manager, IT Quality Assurance

    1 week ago

    Raleigh, North Carolina, United States GILEAD Sciences Full time

    About Gilead Sciences Inc.Gilead Sciences Inc. is committed to fostering a healthier world for all individuals. With a focus on addressing diseases such as HIV, viral hepatitis, COVID-19, and cancer for over 35 years, we aim to develop innovative therapies that improve lives and ensure global access to these treatments. Our dedication to tackling significant...

  • Senior Manager, IT Quality Assurance

    2 weeks ago

    Raleigh, North Carolina, United States GILEAD Sciences Full time

    About Gilead Sciences Inc.Gilead Sciences Inc. is committed to fostering a healthier global community. With over 35 years of experience in tackling diseases such as HIV, viral hepatitis, COVID-19, and cancer, we focus on developing groundbreaking therapies that improve lives and ensure worldwide access to these essential treatments. Our dedication to...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Raleigh, North Carolina, United States Wakefield-Vette Full time

    Company Overview: Wakefield-Vette is a prominent entity within the Heico Companies, collectively generating over $3.2 billion in revenue. We are recognized globally for our pioneering thermal management solutions across various sectors. With over four decades of expertise, we design, manufacture, and distribute products that effectively dissipate excess heat...