Quality Deviation Specialist Job at IKEA (Shanghai)

Technical & Quality Centre Quality Product Analysis Specialist

The Quality Product Analysis Specialist plays a critical role within the Technic...

Location

United Kingdom , Rotherham

Salary:

Not provided

NAPA Auto Parts

Expiration Date

Until further notice

Requirements

Proven Experience: Ideally 3–5 years as a senior technician or diagnostic specialist in a high-volume garage, remanufacturing environment, or warranty inspection role
Certification: Level 3 Automotive Technician qualification or equivalent (e.g., IMI or City & Guilds)
Failure Analysis Training. Warranty Training: Experience or formal training related to warranty claim evaluation and processing preferred
Multi-System Mastery: Deep mechanical knowledge of modern vehicle and electronic systems
Electrical Proficiency: Ability to read electrical schematics and use multimeters or oscilloscopes to test rotating electrics and electronic sensors
Software Literacy: Comfortable with PC-based diagnostic software, CRM portals, warranty management systems, and standard office tools (e.g., Microsoft Word/Excel)
Precision Measurement: Skilled with precision tools such as micrometers, vernier calipers, and dial indicators for checking tolerances and shaft play
Warranty & Compliance Knowledge: Understanding of warranty policies, claim processing procedures, and applicable regulatory standards
Analytical Thinking: Logical, detective-like mindset adept at solving complex diagnostic puzzles that other technicians may overlook
Attention to Detail: Precision in inspecting fracture surfaces, wear patterns, and minute electrical deviations

Job Responsibility

Component Inspection: Conduct detailed physical and functional inspections on a wide range of components including turbos, braking systems, suspension units, clutches, and rotating electrics (alternators/starters)
Diagnostic Testing: Operate specialised test equipment (e.g., vacuum testers, electronic actuator testers, battery/alternator analysers, brake DTV machines, and brake caliper testers) to verify part performance against factory specifications
Root Cause Analysis: Investigate and determine the underlying cause of failure (e.g., carbon buildup, oil starvation, electrical surges, installation errors) to support warranty claim evaluations
Warranty Claim Assessment: Review and assess warranty claims in accordance with company policies, determining validity and identifying potential manufacturing or usage defects
Digital Reporting & Documentation: Utilise computer systems to log findings, upload digital photos of defects, generate professional inspection and warranty evaluation reports, and maintain accurate records for claim processing
Quality & Compliance: Maintain a clean, organised laboratory/testing environment ensuring all test equipment is in safe and calibrated working order. Ensure inspections comply with company standards and relevant regulatory requirements
Cross-Functional Communication: Collaborate closely with warranty administration, customer service, and re manufacturing teams to share findings, explain technical details, and support timely claim resolution

What we offer

We offer comprehensive benefit plans and programs designed to support your health and wellness, provide income protection and build financial security for your retirement

Specialist Quality Assurance

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
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
All medical related expenses incurred from this medical check shall be borne by the company

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

Specialist, Quality Control, Chemistry

As a QC Specialist – Chemistry, you will play a key role in ensuring the quality...

Location

Spain , Madrid

Salary:

Not provided

Moderna

Expiration Date

Until further notice

Requirements

BA/BS in Chemistry (preferred) or other relevant scientific discipline with 2-5 years' experience. A student in an undergraduate program (BA/BS) is acceptable.
2-5 years of experience in quality control laboratory of a pharmaceutical company
Hands on experience with analytical chemistry testing including chromatographic techniques- HPLC, UPLC, Spectroscopic and Spectrometric techniques
Physical properties techniques such as Particle Analysis by Dynamic Light Scattering and others.
Working experience in a GMP environment.
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
This position is site-based, requiring you to be at Moderna's site full-time.
Proficiency in English (verbal and/or written) required due to global collaboration needs.

Job Responsibility

Performing routine analytical chemistry testing such as HPLC, UPLC, UV, particle analysis, and dynamic light scattering.
Executing and supporting stability studies and GMP release testing.
Managing LIMS (LabVantage) sample result entries and executing electronic assay forms.
Assisting with method transfers and development activities across the QC Chemistry function.
Supporting special projects and ongoing initiatives in QC laboratory optimization and compliance.
Performing general laboratory operations including sample management, reagent preparation, equipment maintenance, and lab housekeeping.
Completing and maintaining cGMP documentation and ensuring full data integrity compliance.
Writing and revising SOPs, protocols, and reports in accordance with internal and external requirements.
Contributing to the training and troubleshooting activities for more junior staff.
Participating in investigations, deviations, change controls, and CAPAs within quality systems.

What we offer

Best-in-class healthcare, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being with access to fitness, mindfulness, and mental health support
Family building benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investments to help you plan for the future
Location-specific perks and extras

Fulltime

Senior Quality Specialist

Climeworks is a leading high-quality carbon removal provider, combining decades ...

Location

Switzerland , Opfikon

Salary:

Not provided

Climeworks

Expiration Date

Until further notice

Requirements

You hold a degree in Chemistry or Analytical Chemistry
an advanced degree is a plus and strong applied laboratory experience is essential
You bring at least five years of industrial experience in a relevant field such as specialty chemicals, polymers, resins, or advanced materials manufacturing, with a proven track record in quality control and quality assurance
You are confident with material characterization and release testing, for example GC, IC, HPLC, FTIR, TGA, BET surface area, moisture and elemental analysis, and particle size methods, and you choose fit for purpose methods for routine release and investigations
You have deep expertise in method validation and verification, including designing protocols, defining specifications and acceptance criteria, estimating measurement uncertainty and detection limits, and ensuring data integrity across the full data life cycle
You have proven expertise in building and maintaining inspection ready documentation, authoring SOPs, test methods and work instructions, and operating within ISO based quality frameworks in fast growing environments
You are experienced in planning and conducting supplier and manufacturer audits on QC topics, assessing quality systems and measurement capability, gathering evidence, and driving effective corrective and preventive actions through to closure
You work fluently with LIMS and SAP QM for sample management, specification control, results review and release workflows, and you collaborate confidently with suppliers, manufacturers, Procurement, Product Owners and Operations
You communicate clearly and pragmatically in English.

Job Responsibility

You ensure robust quality control and quality assurance for sorbent materials and related QC processes in a dynamic scale‑up environment
You plan and coordinate QC campaigns for sorbents and related materials
You oversee measurements to meet workload and timelines
You review and approve QC data within defined QC specifications and testing standards
You maintain inspection‑ready documentation and records in SAP QM and linked systems
You manage deviations and change controls arising from QC activities and QC‑owned processes
You are responsible for method validation activities
You identify bottlenecks across QC processes and documentation as well as data handling
You act as the QC technical interface to suppliers and manufacturers
You support Procurement with commercial and contractual topics

What we offer

25 paid vacation days every year
public holidays
Hybrid work setup
Up to 4 weeks of remote work annually within any EU country
Fair base pay paired with an equity package
Inclusive parental leave
Dedicated budget to invest in your professional growth
Referral rewards

IT Quality-Specialist

Join Amgen’s Mission of Serving Patients. In this vital role you will lead the e...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree with a minimum of 7 years experience in Software and Systems Quality assurance
Bachelor’s degree with a minimum of 10 years of Software and Systems Quality assurance experience
Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards
Proven experience in the validation of computerized systems (GxP)
Strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP)
Experience managing quality assurance processes, including Major and Minor Deviations
Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills
Strong decision-making abilities with the capacity to drive tasks to completion
Ability to work independently with minimal supervision
Leadership skills with experience leading projects, teams, or tasks

Job Responsibility

Lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures
Supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation
Actively participate during all phases of qualification/validation of computerized systems: evaluate projects
provide guidance and technical information to others (lead qualification/validation activities)
determine and establish requirements for qualification/validation of each individual system/equipment
formulate independent decisions related to qualification/verification activities
Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis
Serve as Owner or QA Contact for Minor and Major Deviations
Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations
Bring critical exceptions or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

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Quality Deviation Specialist

Job Description

Job Responsibility

Requirements

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