Senior Specialist, Quality Assurance Job at Baxter (Minato, Tokyo)

Senior Specialist, Quality Assurance

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Japan , Minato, Tokyo

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Minimum 5 years of pharmaceutical quality experience and CMO management
Knowledge of PMD Act, GQP/GMP/QMS ordinances, and related regulations
Experience managing CMOs
Experience handling authority and overseas audits
Experience managing inspections from application to completion
Knowledge of pharmaceuticals and medical devices
Willingness to take on new challenges
Positive mindset and teamwork
Analytical and negotiation skills
English proficiency

Job Responsibility

Management and operation of GQP and GMP-related activities
Management and operation of QMS
Handling GMP/QMS compliance inspections
Quality assurance of pharmaceuticals and medical devices
Self-inspections, internal audits, and external audits
Manage, operate, and maintain GQP
GMP oversight for domestic and overseas manufacturers
Manage contract manufacturing organizations (CMOs)
Manage, operate, and maintain QMS
Application, coordination, and execution of inspections

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Senior Specialist, Quality Assurance

Serve as a key Quality leader supporting Global Supplier Quality (GSQ) and Suppl...

Location

United States

Salary:

149651.00 - 168146.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of Quality Compliance experience
Master’s degree & 4 years of Quality Compliance experience
Bachelor’s degree & 6 years of Quality Compliance experience
Associate’s degree & 10 years of Quality Compliance experience
High school diploma / GED & 12 years of Quality Compliance experience
Bachelor’s degree in Life Sciences or Engineering
Experience leading or participating in key roles for Regulatory/Health Authority inspections
Experience auditing and defending processes/procedures during inspections
7+ years of related pharmaceutical industry experience (manufacturing, process development, QA) with increasing responsibility
Experience in quality systems, compliance, data analysis, project management, and supplier/CMO management

Job Responsibility

Own and lead the SQM/GSQ inspection readiness processes
Provide strategic and tactical leadership for inspection and audit preparation, execution, and response
Act as a front-room representative for QMS audits and inspections for External Supply Virtual Sites
Collaborate broadly across GSQ, SQM Global Process Owners (GPO), Amgen site networks, and Affiliates
Maintain and continuously improve inspection readiness processes
Lead or support responses and improvement actions resulting from Regulatory Agency inspections, Business Partner audits, and internal audits
Drive proactive identification, communication, and resolution of site and cross-functional compliance risks
Act as SME for QMS A&I processes, supporting major initiatives such as DQMS Phase 2 implementation
Contribute to or lead project teams supporting business objectives including quality systems, continuous improvement, and digital QMS transformation

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Senior Quality Assurance Specialist

CK Group are recruiting for a Senior Quality Assurance Specialist to join a glob...

Location

United Kingdom , Uxbridge

Salary:

29.00 GBP / Hour

CK Group

Expiration Date

Until further notice

Requirements

Hold a relevant scientific degree or have equivalent working experience
In-depth knowledge of cGMP / GDP regulations pertinent to the USA, EU and other international markets
Ability to build relationships, partnerships and influence stakeholders
Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically FDA and/or EMA
Experience in interacting with external manufacturers and supporting quality at external manufacturing sites
Hold entitlement to work in the UK

Job Responsibility

Responsible for QA vendor oversight
Manage contractor quality assurance activities
Identify and recommend quality-related improvements
Manage change control requests
Review batch records
Support GMP/GDP site inspections

Fulltime

Senior Specialist – Quality Assurance

The QA Specialist will work in projects related to Adobe Campaign, Adobe Experie...

Location

India , Gurugram

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Bachelor’s degree required
Master’s degree preferred (MBA/MS Computer Science/M.Tech Computer Science, etc.)
Overall 5-7 years of relevant experience in QA domain with Adobe Campaign Classic, AJO, CDP, AEP
Relevant working experience in a communication platform or MarTech stack
Adobe certifications preferred
Ability to program in HTML/CSS/JavaScript
Ability to write & understand complex SQL queries
Understanding of Email, SMS, PUSH, including responsive design principles, templating, and data schemas
Deep knowledge of email marketing principles including responsive design and familiarity with cross-client rendering issues & test practices across email clients. (e.g. Gmail, Outlook, Yahoo, etc)

Job Responsibility

Design and execute comprehensive test plans for campaigns, workflows, segments and real-time journeys across Adobe Campaign Classic, AJO and AEP environments
Validate campaign configurations, personalization logic and dynamic content rendering across email, SMS, and in-app channels in ACC/AJO/CDP
Conduct end to end testing of customer journeys in AJO, ensuring triggers, conditions and touchpoints behave as expected based on customer behavior and profile data
Validate schema configurations, data sets and event configurations in ACC/AEP/AJO
Run rendering tests across major email clients (e.g. Outlook, Gmail, Yahoo) and devices (desktop, tablet, mobile) using tools like Email on Acid, Litmus, etc to ensure consistent cross=platform customer experiences
Validate UTM parameters and tracking links for proper analytics attribution and campaign performance monitoring. Review email design elements to ensure they align with standards and testing all hyperlinks, CTAs to ensure they lead to the intended destinations
Ensure compliance with internal QA standards, marketing governance policies and data privacy regulations
Collaborate with Stakeholders to plan test schedules & strategies in accordance with project scope or delivery dates
Documenting any issues identified during the QA process and regularly optimizing the QA checklist
Manage and optimize data processes, conducting knowledge share sessions within the team so as to ensure 100% quality and avoiding redundancy of internal errors

Quality Assurance Specialist

The Quality Assurance Specialist is responsible for coordinating TCR development...

Location

United States , Carlsbad

Salary:

Not provided

Crow Holdings

Expiration Date

Until further notice

Requirements

Bachelor's degree in business, management or related field required
5 years of related experience in construction procedures, trade practices, materials, means and methods, building codes, project scheduling, and safety procedures
Familiarity with federal and local municipal/regulation codes
OSHA Certification required
Current driver's license and automobile insurance
Must maintain professional appearance
Ability to be at work on a regular and consistent basis
Moderate travel may be required

Job Responsibility

Assist on a daily basis, the Quality Assurance Manager in the division, if present in day to day operations for his or her job duties
Coordinate all plan reviews and field inspections with consultants including Accessibility, Third Party Architectural, Waterproof, Tyvek (or other WRB) Environment/AQI and Acoustical
Responsible for initiating, executing, implementing and tracking all plan and site inspections for all projects in the Division (s)
Maintains close contact with superintendent and project manager on changes to schedules and turn dates for up to four projects simultaneously
Responsible for monthly QA documentation project inspection walks with published report
Responsible for acceptance of new residential construction buildings and property from Construction division and coordinating/aligning with Asset Management
Manages third party quality inspections, if used for a project
Oversee all details within the boundaries of the new property and ensure quality standards set forth by the Division’s Senior Managing Director and Construction President are maintained for all TCR properties
Coordinate with 3rd party Property Manager and Construction Superintendent or Project Manager to ensure all warranty and construction quality deficiency issues are addressed
Work closely with third party safety consultant to make observations and recommendations on safety for all persons and matters related to the property and TCR Construction projects

Fulltime

Specialist Quality Assurance – Drug Substance Deviations

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master's degree and 2 years of Quality Assurance experience
OR Bachelor's degree and 4 years of Quality Assurance experience
OR Associate's degree and 8 years of Quality Assurance experience
OR High school diploma / GED and 10 years of Quality Assurance experience

Job Responsibility

Provide Quality oversight to ensure clinical and commercial pharmaceutical products are manufactured, tested, stored, and distributed in compliance with cGMP and applicable regulations
Provides an additional QA oversight by critically reviewing and challenging deviation designations made at the shop floor to ensure accurate, consistent, and compliant classification
Collaborates with Manufacturing and cross-functional stakeholders to reassess impact, drive alignment, and support sound decision-making
Provides QA oversight by critically reviewing and challenging initial deviation write-ups to ensure accurate reflection of the event
Partners with deviation owners to strengthen event descriptions and ensure a clear, compliant initial resolution
Ensures that required sections, including further processing and continued operations, are completed accurately and within established timelines
Serve as Deviation QA Contact and decision-maker for deviations, maintaining accountability for investigation quality, timelines, documentation, and closure
Actively participate in deviation and RCA meetings, managing multiple concurrent deviations and driving effective resolution
Conduct thorough root cause investigations, including floor presence, process observation, and personnel interviews across shifts, including nights when required
Review, approve, and track cGMP documentation, including Deviations, CAPAs, CAPA Effectiveness Verification (EV), Change Controls, validations, and associated records

What we offer

health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions
group medical, dental & vision coverage
life & disability insurance
discretionary annual bonus program
stock-based long-term incentives
award-winning time-off plans

Fulltime

Specialist Quality Assurance – Drug Product Minor Deviations

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master's degree and 2 years of Quality Assurance experience
Bachelor's degree and 4 years of Quality Assurance experience
Associate's degree and 8 years of Quality Assurance experience
High school diploma / GED and 10 years of Quality Assurance experience

Job Responsibility

Serve as Quality investigation lead and decision-maker for complex deviations, maintaining accountability for designation, documentation quality, timeliness and closure
Actively participate in deviation meetings, managing multiple concurrent deviations and driving effective resolution
Provide Quality oversight to ensure thorough documentation of deviations, including floor presence, process observation, and personnel interviews across shifts, including nights when required
Review, approve, and track cGMP documentation, including Deviations, procedure updates and associated records
Demonstrate strong critical thinking skills, the ability to distinguish between a minor and mayor designation using evidence-based decision making
Ensure that deviations with potential impact to product quality are properly assessed and documented per established procedures
Verify that deviations from established procedures are investigated, documented, and resolved in accordance with Quality System requirements
Ensure production records, laboratory results, and investigation documentation to be used as evidence for deviations are complete, accurate, and compliant with cGMP standards
Collaborate cross‑functionally with Manufacturing, Engineering, Validation, and Quality to ensure information required for designation and/or closure of deviations is complete and accurate
Escalate and communicate quality, compliance, supply, and patient safety risks to senior management as appropriate

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Specialist Quality Assurance (API)

Amgen is one of the world’s leading independent biotechnology companies. For ove...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 2 years of directly related experience OR Bachelor's degree and 4 years of directly related experience OR Diploma and 8 years of directly related experience
8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical / biologics industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems
Direct experience with bulk manufacturing of biopharmaceuticals/API preferred
Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
Experience with regulatory audits and inspections
Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality

Job Responsibility

Provide Quality oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System in plant operations through phases of commissioning, process qualification, regulatory approval and market supply
Support routine GMP documentation review activities (e.g. electronic batch records, SOPs, logbooks, work orders, batch production reports and validation protocols etc.) and ensure key performance indicator met targeted metrics
Co-lead and support the deployment of Amgen quality systems, including management review, validation, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations
Participate in complex root cause investigations for deviations
Review and approve deviation investigations, change controls, and other quality records (with focus on highly complex records)
Provides Quality Assurance support in New Product Introduction (NPI) team
Coach site Quality Assurance professionals on resolution of complex problems
Participate in regulatory inspections, and interact directly with regulatory inspectors
Supporting other Quality Assurance initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

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