Senior Associate Quality Assurance Job at Amgen (Thousand Oaks)

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Senior Associate Quality Assurance

The Senior Associate QA will be required to perform 12-hour shift (rotational ni...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Masters Degree OR Bachelor's Degree and 2 years of directly related experience OR Associate's Degree and 6 years of directly related experience OR High School Diploma / GED and 8 years of directly related experience
Preferred 5+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical / biologics industry and understanding of GMP pharmaceutical production, biological drug substance experience and operation
Experience with batch record review, and quality record support
Experience in pharmaceutical equipment operation, design and control including GMP change control
Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
Understanding of equipment log review and continuous monitoring requirements
Good communication skills (technical writing and verbal communication/presentation)
Interacts effectively with variety of communication and working styles
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

Conduct Quality Assurance activities related to quality floor support for solution and equipment preparation, cell culture and product purification & Drug Substance Filling operations
Support of electronic batch record review and approval, change control, investigations and product release
Work in a cross functional team with Process Development, Manufacturing, Supply Chain, Engineering and Facilities to ensure product quality and market supply
Role may include participation in new product introductions, additional equipment, installation commissioning, qualification
Support continuous improving initiatives

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

Senior Associate Quality Assurance

As an Applications Managed Services Engineer (L2) at NTT DATA, your primary miss...

Location

Indonesia , Jakarta Selatan

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Hands-on experience managing platforms, including ErP, Middleware, and other business-critical software
Moderate experience in managed services with knowledge of using ticketing tools like ServiceNow
Ability to handle multiple tasks, execute change management duties, and lead troubleshooting processes effectively
Ability to plan activities and adapt quickly to changing circumstances
Effective communication skills and the ability to work across different cultures and social groups
Active listening skills to understand clients' needs and craft a positive client experience
Capacity to maintain a positive outlook, even in a pressurized environment, and put in extra effort when necessary
A bachelor’s degree in information technology/computing or equivalent work experience

Job Responsibility

Proactively monitor, investigate, and resolve application-based incidents, service requests, and alerts
Handle second-line support with a medium level of complexity, focusing on resolving client requests and issues without breaching any service level agreements (SLAs)
Update tickets with resolution tasks and promptly log incidents
Communicate with other teams and clients to extend support where needed
Execute changes carefully and ensure all changes are properly documented and approved
Work with automation teams to optimize efforts and coach Service desk and L1 teams
Lead initial client escalations for operational issues
Identify problems before they impact client services and contribute to producing trend analysis reports for continuous improvement
Support project work, execute approved maintenance activities, and assist in implementing and delivering disaster recovery functions

Fulltime

Senior Associate Quality Assurance

The Incoming Quality Assurance (IQA) Associate position will provide support for...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Masters Degree OR Bachelor's Degree and 2 years of directly related experience OR Associate's Degree and 6 years of directly related experience OR High School Diploma / GED and 8 years of directly related experience
5 years of experience in regulated environment
Experience and basic troubleshooting skills with laboratory and process equipment
Experience with LIMS, SAP, TrackWise, Veeva
Ability to understand, apply and evaluate basic chemistry
Ability to adhere to regulatory requirements, written procedures and safety guidelines
Ability to evaluate documentation/data according to company and regulatory guidelines
Ability to interact with inspectors (internal and external)
Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
Ability to organize work, handle multiple priorities and meet deadlines

Job Responsibility

Comply with safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements
Complete required assigned training prior to execution of required tasks
Perform raw material inspection, sampling and rapid ID testing in accordance to written SOPs and Methods.
Generate complete and accurate documentation using electronic or handwritten systems.
Review records to ensure raw materials are tested and inspected according to specification and SOPs
Perform business operations related to inspection/sampling/testing (i.e updating dashboards, relevant metrics, housekeeping, inventory management, audit support)
Support site/network Continual Improvement initiatives
Ensures facilities, equipment, materials and procedures comply with cGMP practices and other applicable regulations
Alert management of quality, compliance, supply and safety risks in a timely manner
Participate in raw material issues or deviations

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

Senior Associate Quality Assurance

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

Location

United States , New Albany

Salary:

82081.95 - 111052.05 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years quality work experience
Associate’s + 2 years quality work experience
Bachelor’s + 6 months quality work experience
Master's
Bachelor’s degree in Life Sciences, Engineering, or related field
1+ years of experience in Quality Assurance within a GMP environment (biotech/pharma preferred)
Strong knowledge of cGMP regulations and industry best practices
Experience with batch record review, and deviations
Ability to work flexible shifts, including evenings, nights, weekends, or holidays as needed
Excellent communication, problem-solving, and organizational skills

Job Responsibility

Providing on-the-floor QA support for manufacturing activities across assigned shifts
Ensuring adherence to GMP regulations and internal quality standards
Reviewing and approving batch records, logbooks, and quality documentation
Supporting deviations
Partnering cross-functionally with Manufacturing, QC, and Engineering teams
Identifying opportunities for continuous improvement and operational excellence
Acting as a quality advocate, promoting a culture of compliance and accountability

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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans

Fulltime

Senior Associate Quality Assurance

The Senior Associate Quality Assurance role at NTT DATA involves ensuring the pe...

Location

Indonesia , Jakarta Selatan

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Hands-on experience managing platforms, including ErP, Middleware, and other business-critical software
Moderate experience in managed services with knowledge of using ticketing tools like ServiceNow
Ability to handle multiple tasks, execute change management duties, and lead troubleshooting processes effectively
Ability to plan activities and adapt quickly to changing circumstances
Effective communication skills and the ability to work across different cultures and social groups
Active listening skills to understand clients' needs and craft a positive client experience
Capacity to maintain a positive outlook, even in a pressurized environment, and put in extra effort when necessary
A bachelor’s degree in information technology/computing or equivalent work experience

Job Responsibility

Ensure that our clients' packaged application technologies, such as ErP and Middleware, are always in top shape
Proactively monitor, investigate, and resolve application-based incidents, service requests, and alerts
Handle second-line support with a medium level of complexity, focusing on resolving client requests and issues without breaching any service level agreements (SLAs)
Update tickets with resolution tasks
Log incidents promptly
Communicate with other teams and clients to extend support
Execute changes carefully and ensure that all changes are properly documented and approved as part of the change management process
Work with automation teams to optimize efforts
Coach Service desk and L1 teams
Lead initial client escalations for operational issues

What we offer

Workplace embraces diversity and inclusion
A place where you can grow, belong and thrive
Part of a global company with experts in more than 50 countries

Fulltime

Senior Associate Quality Assurance

Part-time job: 30 hours/week. CW position - via personnel agency. Employment con...

Location

Czech Republic , Prague

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

University Degree in Pharmacy, Chemistry or Medicine
Fluency in Czech and English languages

Job Responsibility

Ensures adherence to EU GDP requirements and the Czech regulations in relation to Wholesale Distribution
Maintains Quality Management System at the affiliate level in compliance with Czech regulations and Amgen standards
Performs Quality-related activities for Czech market
Supports regional activities to maintain quality system and executes tasks in compliance with Amgen’s Quality Management System, GMP & GDP requirements and any local applicable regulations
Supports QA Manager and Responsible Person to ensure that Quality Management System is implemented and maintained in compliance with the requirements of the EU GDP and applicable regulations in Czech Republic
Ensures that documentation is accordingly processed, records are accurate and up to date and kept according to applicable requirements
Ensures personnel involved in GDP activities are adequately trained
Supports handling of Product Complaints, identification of Adverse Events, Medical Information enquiries and brand protection issues as well as potential counterfeit
Supports authority inspections, audits, and self-inspections
Makes the disposition decision of the medicinal products (including product release) to Czech market

Parttime

Quality Assurance Senior Associate, Drug Substance Plant

In this role as Senior Associate QA, you will be responsible for providing quali...

Location

United States , Thousand Oaks

Salary:

86928.00 - 106536.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years quality assurance work experience
Associate’s + 2 years quality assurance work experience
Bachelor’s + 6 months quality assurance work experience
Master's
Quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor’s Degree in a Science Field
Ability to successfully manage workload to timelines
Familiarity with basic project management tools
Demonstrated ability to consistently deliver on-time, and high-quality results
Ability to operate in a matrixed or team environment

Job Responsibility

Provide daily guidance and support to Production staff on compliance with Standard Operating Procedures (SOPs) and Work Instructions
Maintain a strong presence in Drug Substance (DS) areas to oversee GMP operations and quality systems
Serve as the first point of contact for quality-related production queries during DS operations
Lead, mentor, and coach Operations and support personnel on quality matters, fostering a strong Quality culture at the site
Review and approve batch production records and other GMP documentation to support daily operations
Compile and review batch records for manufactured lots in preparation for batch disposition
Own, review, and approve controlled documents, including SOPs, Work Instructions, and Forms
Collaborate effectively within a team matrix environment
Work across a three shift rotation including night shift

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, 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

Senior Associate - Quality Assurance

At Bolt.Earth, we’re building the backbone of sustainable mobility—fast. We are ...

Location

India , Bengaluru

Salary:

Not provided

Bolt.Earth

Expiration Date

Until further notice

Requirements

BE in Electrical/ Electronic Engineering
3 to 5 years of experience in Supplier Quality Assurance preferably in Electronics / Automotive industry
Effective problem solving, root-cause analytical skills
Understanding and knowledge of Manufacturing engineering and Quality standards
Knowledge of Quality Management System. (ISO 9001:2015 and IATF16949:2016)
Continuous improvement methodologies & in-depth understanding of Electrical / Electrical products & related processes
Ability to schematics, circuit diagrams to manage from data

Job Responsibility

Participate in Supplier Evaluation & Evaluate the supplier's Quality System
Development of Products & Components at supplier End – Built to Print & Full Service Supplier
Feasibility & Requirement Sign off along with Warranty Requirements
Assist with first article inspection and PPAP whenever possible for all first time orders by new suppliers or first time deliveries of new part numbers by existing suppliers
Act as the liaison in-house to get information, engineering changes or deviation requests when necessary
Review, validate and approve supplier corrective actions
Manage and improve Supplier performance on Part Quality
Supplier Up gradation in Technology and Quality systems
Monthly Vendor Rating

What we offer

We’ll cover your EV EMIs
Courses, mentoring, and all the feedback you can handle
Work how you work best – WFO, remote or hybrid
Flexible schedules, insurance, comprehensive wellness programs, and mental health support
Referral rewards: Share the Bolt.Earth love and earn 50% of monthly CTC of the candidate
Quarterly off-sites, hackathons, and culture-building events

Fulltime

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Senior Associate Quality Assurance

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Quality Assurance Senior Associate, Drug Substance Plant

Senior Associate - Quality Assurance

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