Customer Quality Assurance Specialist Job at Bsport (Barcelona)

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Specialist Quality Assurance

Responsible for providing oversight and leadership for quality systems execution...

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

Quality Assurance Specialist

As the largest pureplay adhesives company in the world, H.B. Fuller’s (NYSE: FUL...

Location

United States , Simpsonville

Salary:

70000.00 - 80000.00 USD / Year

H.B. Fuller

Expiration Date

Until further notice

Requirements

BS/BA degree required (Chemistry or Engineering degree preferred)
Knowledge of the chemistry and processes involved in the manufacturing of polymers, UV, and blended final mixed solutions is ideal
Ideal candidate can be entry-level or 3+ years of experience if has co-op/intern experience in an applicable industry
Ideal candidate is an experienced quality or process professional with three years of lab, quality and/or process manufacturing experience who operates with a sense of urgency and brings a proven track record in transforming site manufacturing
He/she comes from an environment of equivalent size, complexity and multiple products and applications
Management of Change process understanding or experience
A point of contact on customer complaints and experience completing root cause and corrective actions
Hands on analytical lab experience operating equipment such as GC, HPLC, FTIR, Viscometer, pH meter, Gravimetric analysis
Effectively engage employees at all levels in a positive manner that fosters team building and community, and help identify succession plans for high potential employees
Must possess effective, strong communications and analytical skills, be persuasive and have good general management acumen

Job Responsibility

Manages assets efficiently from an environmental, health, safety perspective while ensuring quality production, high customer service levels, low inventory and keeping costs/expenses within target budget guidelines
Aligns continuous improvement initiatives with strategic objectives and key performance metrics to successfully manage programs and processes that support strategic goals, particularly as they relate to quality and the journey to zero defects
Drives operational improvements in safety, quality and productivity by employing Lean, Six Sigma, and Operational Discipline methodologies to achieve business objectives
Creates a culture where safety is a value that results in top quartile safety performance, where the organization proactively identifies and reduces risk to create a safe and healthy work experience for all
Promotes a “Customer First” mindset and culture through proactive employee identification of process improvements to yield superior quality and customer service in accordance with targeted metrics
Complies with and proactively adheres to all governmental regulations and requirements
Exhibits strong influencing skills in a matrix environment, by being approachable and involved with key constituencies at all levels and working effectively across geographic/functional lines
Experience and demonstrated capability with a global ERP/SAP systems

What we offer

comprehensive benefits
incentive and recognitions programs
health & wellness benefits
401K contributions
paid time off
paid holidays

Fulltime

Quality Assurance Specialist

The Quality Assurance Specialist will be responsible for monitoring phone calls ...

Location

United States , West Valley City

Salary:

Not provided

OneMain Financial

Expiration Date

Until further notice

Requirements

Customer Service: 1 year
High School Diploma or equivalent
Interpersonal skills promoting a team environment
Six (6) months experience in relevant position or equivalent preferred

Job Responsibility

Review application documents for accuracy prior to funding
Assist in the development of the quality assurance practices throughout the originations departments
Develop, update, and facilitate QA related trainings and/or calibration meetings as needed
Review of customer and/or dealership phone, chat, SMS, and email interactions
Deliver regular QA score reports and a monthly QA score report to management
Assist in process improvement in existing systems and processes to drive quality and efficiency and enhance customer experience
Assist departments in maintaining compliance with all Federal and local regulations
Assist in revisions of internal, departmental policy documents and training reference materials
Other duties as assigned by the Operations Manager

What we offer

Paid time off (15 days' vacation per year, prorated based on start date)
Paid sick leave as determined by state or local ordinance (prorated based on start date)
11 Paid holidays (4 floating holidays, prorated based on start date)
Paid volunteer time (3 days per year, prorated based on start date)

Fulltime

Quality Assurance Specialist

As a Quality Assurance Specialist with a focus on SAR Reporting at Wise, you are...

Location

United States , Austin

Salary:

70500.00 - 84600.00 USD / Year

Assessfirst

Expiration Date

Until further notice

Requirements

Professional experience: 2+ years of experience in QA related to BSA/AML or experience in AML Investigations or SAR Reporting
Strong understanding of BSA/AML regulations and SAR requirements
Fluent in English (written and verbal skills) with the ability to clearly articulate your thoughts and recommendations
Self-Development: Takes ownership for personal development, including commitment to develop expertise through industry and trend analysis, regulatory insights, and emerging risk typologies
Quality Assurance methodology: Good understanding of Quality Assurance methodologies and frameworks, including testing procedures, scoring criteria and root cause analysis
Risk and Compliance expertise relevant to SAR Reporting, including the ability to identify and assess risks, interpret and apply policy requirements and guidance, and a good understanding of the regulatory environment applicable to the function
Analytical Skills: Efficient at reviewing and investigating customer files, identifying missing information, issues, trends and root causes, using AI and data as appropriate
Systems and Tools: Competent using case management systems, dashboards, AI tools to support case working and analysis
Critical thinking: Ability to critically assess information, demonstrate attention to detail, challenge assumptions, dig deeper where required, ask the right questions and connect data across different sources to make informed and risk-based decisions
Risk management: Uses facts, data, policy and risk frameworks to support conclusions and assess risk materiality ensuring decisions can be justified

Job Responsibility

Conduct holistic, risk-based reviews using test scripts and scorecards to assess risk outcomes, compliance with global and regional policies, relevant guidance and risk appetite
Assess risk, materiality and root causes for each finding, providing clear and robust reasons aligned to policy compliance and/or risk mitigation
Participate in calibration exercises to share findings, best practice and ensure consistent, correct decisions are made across the team
Clearly communicate outcomes to stakeholders covering key risks, issues, root causes, and recommendations, maintaining robust records and audit trails
Analyse, assess and communicate emerging themes and trends, recommending opportunities for continuous improvement
When assigned, scope, plan, and execute root cause analysis or targeted investigations
Contributes to team collaboration and knowledge sharing to enhance team capabilities
Take a proactive approach to consistently achieving individual and team targets (KPIs, SLAs), demonstrating a strong commitment to both quality and speed
Perform additional tasks as assigned by your lead, demonstrating adaptability and a proactive approach
Embody and uphold Wise’s values in daily interactions

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

Quality Assurance Specialist

Join Our Team as a Quality Assurance Specialist! Are you passionate about ensuri...

Location

United Kingdom , Hastings

Salary:

25000.00 - 28000.00 GBP / Year

Office Angels

Expiration Date

Until further notice

Requirements

Solid understanding of Quality Management Systems and Good Manufacturing Practices
Experience in standard operating procedures, document control, and complaints investigation
Strong problem-solving skills and a keen eye for detail
Excellent verbal and written communication abilities
Capability to manage multiple priorities and work independently with minimal supervision
Experience with Quality Management Systems, NC/CAPA, Supplier Management, and Internal Auditing

Job Responsibility

Conduct thorough incoming goods inspections and ensure timely release of goods
Monitor and support product verification, including spot checks and audits
Maintain and coordinate documentation within our Document Control System (GDMS)
Assist in evaluating customer complaints and support CAPA investigations
Conduct supplier qualifications and keep supplier files up to date
Participate in internal and supplier audit programs and prepare for Notified Body audits
Deliver GMP training as needed and assist in preparing quality reports and management reviews
Engage in plant tours and data integrity checks to uphold our quality standards

What we offer

Be part of a friendly, supportive team that values your input and ideas
Enjoy a fulfilling career where your work directly impacts customer and patient safety
Work closely with a diverse team, including site leadership and manufacturing professionals

Fulltime

Quality Assurance Specialist

Under the direction of the Medical Director and Quality Assurance Supervisor, th...

Location

United States , Kapolei

Salary:

22.03 USD / Hour

Blood Bank of Hawaii

Expiration Date

Until further notice

Requirements

Bachelor's degree in a science-related field or equivalent experience in an FDA-regulated industry preferred
Knowledge of FDA, AABB, HIOSH, and OSHA regulations preferred
Medical terminology knowledge, but not required
Valid driver’s license with a clean driving abstract
3–4 years of experience in a blood bank, clinical laboratory, or regulated industry preferred
ASQ certification (CQIA, CQPA, or higher) preferred
Strong written and verbal communication skills
able to present clear, fact-based information
Effective listening and investigative skills with ability to compile detailed reports
Strong analytical, problem-solving, and critical thinking abilities

Job Responsibility

Investigate, complete, and submit Post Donation Information (PDI) and Biological Product Deviation (BPD) reports, including FDA submissions, product retrievals, and notifications
Evaluate, categorize, and track quality events
lead and facilitate root cause analysis (RCA) and corrective/preventive actions (CAPA), ensuring timely resolution
Initiate and manage event reporting processes
prepare and participate in meetings related to investigations and quality events
Track, trend, and analyze data to identify recurring issues
generate reports and lead investigations for continuous improvement
Plan, conduct, and follow up on internal audits
support external audits (FDA, AABB, DOH, CLIA) including preparation and gap assessments
Ensure organizational compliance with FDA regulations, AABB standards, SOPs, and regulatory updates

What we offer

100% Health, Dental, and Vision Insurance
Matching 401(k) Plan
Paid Time off
Career Development and Training
Opportunities for Promotion
SAVING LIVES EACH DAY

Fulltime

Quality Assurance Specialist

You will be a part of Distribution & In-market Quality Team responsible for acti...

Location

Russian Federation , Moscow

Salary:

Not provided

myGwork - LGBTQ+ Business Community

Expiration Date

Until further notice

Requirements

University Degree in a relevant science (preferably BS Pharmacy, Chemistry, Chemical Engineering, Biology (or equivalent) education)
Basic knowledge of normative documentation, medicines state registration process, local pharmacopeia articles
Basic knowledge of quality confirmation/local certification
Experience and knowledge in the field of logistics (importation, customs clearance, warehousing, transportation including cold chain)
Experience in the field of GMP/GDP and other applicable local legislation is preferable
At least 2 years' experience in the pharmaceutical industry preferably with knowledge of Quality Systems, Quality Assurance and Quality Control including basic knowledge of global GMP/GDP and regulatory requirements
Strong compliance mind-set, motivation, communication and negotiation, multi-task
Some level of contractual and financial awareness is preferred
Excel spreadsheets, SAP, ETQ
English (at least intermediate)

Job Responsibility

Assure compliance with established Company's policies/procedures and comply with all applicable governmental regulations (GMP, GDP, local legislation, etc.)
Maintain the local Quality Management System
Participation in Audits and Self-inspections
Ensure Quality training of personnel including assessment of training effectiveness
Complete trainings as required for role
Handling of product quality complaints (PQCs)
Participation in deviation management, overview and tracking, handling of temperature excursions during transportation, warehousing and distribution
Participation in CAPA management, including tracking
Participation in local recall coordination and execution
Local batch release (routine and one batch per year) - AIS RZN, release in SAP

Fulltime

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Customer Quality Assurance Specialist

Job Description

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