CrawlJobs Logo

Specialist QA - Indirect Plant Technical Quality Assurance

amgen.com Logo

Amgen

Location Icon

Location:
Ireland , Dun Laoghaire

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided

Job Description:

The Indirect Plant Technical Quality Assurance (QA) Specialist is a key role within the QA function, responsible for providing expert quality oversight and guidance across critical processes. This position requires subject matter expertise in assigned areas and the ability to operate across functional boundaries to ensure compliance with GMP and internal standards.

Job Responsibility:

  • Act as QA representative at Change Control and Deviation Review Boards, providing quality direction and input
  • Assume QA oversight of change control and deviation/CAPA records, ensuring clear scope and robust, timely implementation activities
  • Review and approve validation documentation and SOPs to support site validation activities as required
  • Provide input into Annual Product Reviews (APRs)
  • Support a safe working environment by complying with all environmental health and safety practices, rules, and regulations
  • Perform all activities in compliance with Amgen safety standards and SOPs
  • Responsibilities may expand to include additional areas aligned with business needs

Requirements:

  • University degree in Science or Engineering (preferred)
  • Minimum 5 years’ experience in the pharmaceutical or biotechnology industry, with demonstrated expertise in providing quality oversight for key functional areas (e.g., Manufacturing, Validation, Quality Control)
  • Demonstrated ability to act as a Subject Matter Expert in QA processes and systems
  • Strong understanding of validation principles
  • At least 18 months’ experience as QA contact on major deviations
  • Proven experience in change control, CAPA management, and validation practices
  • Ability to work independently and remotely with minimal supervision
  • Excellent organisational, communication, coordination, and meeting facilitation skills
  • Strong critical thinking and problem-solving abilities
  • Collaborative team player, embracing a culture of shared decision-making
  • Familiarity with regulatory requirements and industry standards for GMP compliance
  • Experience in reviewing and approving validation protocols and reports
  • Proven track record of supporting continuous improvement initiatives within a regulated environment

Additional Information:

Job Posted:
January 03, 2026

Work Type:
On-site work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Specialist QA - Indirect Plant Technical Quality Assurance

New

Bilingual Customer Service Representative

We are looking for a dedicated Bilingual Customer Service Representative to join...
Location
Location
United States , Grand Rapids
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Previous experience in a call center or customer service role
  • Proficiency in handling inbound and outbound calls professionally
  • Strong skills in order entry and data accuracy
  • Ability to communicate fluently in English and another language
  • Familiarity with customer management systems and tools
  • Excellent problem-solving skills and the ability to handle challenging situations
  • Strong organizational skills and attention to detail
  • Ability to work effectively in a team-oriented environment
Job Responsibility
Job Responsibility
  • Respond to inbound calls, addressing customer inquiries and resolving issues promptly
  • Provide clear and accurate information about products and services to customers
  • Process and manage order entries with attention to detail and accuracy
  • Maintain high-quality customer interactions by ensuring professionalism and empathy
  • Collaborate with team members to address complex customer concerns
  • Handle outbound calls as necessary to follow up with customers or provide updates
  • Record and maintain customer information in the system for future reference
  • Monitor and ensure compliance with company policies during customer interactions
  • Work effectively in a call center environment to meet service level expectations
  • Identify opportunities to enhance the customer experience and recommend improvements
What we offer
What we offer
  • medical, vision, dental, and life and disability insurance
  • eligible to enroll in our company 401(k) plan
Read More
Arrow Right
New

Senior Events Manager

Prepares all event documentation and coordinates with Sales, property department...
Location
Location
United States
Salary
Salary:
71000.00 - 94000.00 USD / Year
https://www.marriott.com Logo
Marriott Bonvoy
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or GED
  • 2 years experience in the event management or related professional area
  • OR 2-year degree from an accredited university in Hotel and Restaurant Management, Hospitality, Business Administration, or related major
  • no work experience required
Job Responsibility
Job Responsibility
  • Prepares all event documentation and coordinates with Sales, property departments and customer to ensure consistent, high level service throughout the pre-event, event and post-event phases of property events
  • Primarily handles complex events
  • Ensures a seamless turnover from sales to service back to sales
  • Recognizes opportunities to maximize revenue by up-selling and offering enhancements to create outstanding events
  • Supports and acts on behalf of the Director of Event Management or Director of Event Planning and Operations in his/her absence
  • Serves as the event planner’s primary contact (following turnover) on property and is responsible for his/her experience
  • Solve problems and/or suggest alternatives to previous arrangements if necessary
  • Leads pre-event and post-event meetings for assigned groups
  • Identifies operational challenges associated with his/her group and works with the property staff and customer to solve these challenges and/or develop alternative solutions
  • Manages customer budgets to maximize revenue and meet customer needs
  • Fulltime
Read More
Arrow Right
New

Customer Service Representative

Do you possess excellent communication abilities and strong data entry skills? R...
Location
Location
United States , Nampa, ID
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proven customer support experience
  • Strong phone contact handling skills and active listening
  • Familiar with computers
  • Customer orientation and ability to adapt/respond to different types of characters
  • Excellent communication and presentation skills
  • Ability to multitask, prioritize, and manage time effectively
Job Responsibility
Job Responsibility
  • Receive and process incoming calls from customers in an accurate, efficient, and timely manner
  • Maintain solid customer relationships by handling questions and concerns with speed
  • Communicate with other departments within the company
  • Respond to internal questions and issues
  • Review and process documents
  • May require research skills to troubleshoot customer problems
  • Act as support for other teams within the company
What we offer
What we offer
  • Medical, vision, dental, and life and disability insurance
  • Eligible to enroll in company 401(k) plan
  • Access to top jobs, competitive compensation and benefits
  • Free online training
Read More
Arrow Right
New

Vp/director of Finance

We are looking for a highly experienced VP/Director of Finance to lead the finan...
Location
Location
United States , Tunkhannock
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Accounting, Finance, or a closely related field
  • At least 7 years of progressive experience in financial leadership roles, preferably within the financial services industry
  • In-depth knowledge of banking regulations and financial systems
  • Demonstrated ability to lead and manage teams effectively
  • Exceptional analytical, organizational, and communication skills
  • Expertise in annual budgeting, month-end close processes, and financial reporting
  • Proven experience with cash flow forecasting and budget management
  • Strong understanding of asset/liability management and interest rate risk strategies
Job Responsibility
Job Responsibility
  • Conduct comprehensive financial analyses, including performance reviews, trend assessments, and forecasting to aid strategic planning
  • Prepare, present, and maintain accurate financial reports for senior management and the board of directors
  • Ensure compliance with all federal and state banking regulations, including the timely submission of required regulatory documents
  • Oversee daily cash management operations, liquidity planning, and cash flow optimization
  • Manage the organization’s fixed asset portfolio, including acquisitions, depreciation schedules, and disposals
  • Supervise accounts payable and payroll functions to ensure precision, timeliness, and adherence to company policies
  • Reconcile general ledger accounts regularly, addressing and resolving discrepancies promptly
  • Monitor and manage the organization’s investment portfolio, aligning with risk tolerance and return objectives
  • Lead the annual budgeting process, providing variance analyses and recommending cost control measures throughout the year
  • Chair the Asset/Liability Committee to oversee interest rate risk, liquidity risk, and capital adequacy management
What we offer
What we offer
  • medical
  • vision
  • dental
  • life and disability insurance
  • company 401(k) plan
Read More
Arrow Right
New

Senior Events Manager

Directly assist the Assistant Director of Convention Services by providing suppo...
Location
Location
United States
Salary
Salary:
94000.00 - 125000.00 USD / Year
https://www.marriott.com Logo
Marriott Bonvoy
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or GED
  • 6 years experience event management, food and beverage, sales and marketing, or related professional area
  • OR Bachelor’s degree from an accredited university in Hotel and Restaurant Management, Hospitality, Business Administration, or related major
  • 3 year experience in the event management or related professional area
Job Responsibility
Job Responsibility
  • Manage and coordinate Convention Services activities associated with planning, supervising and executing events for more complex and high touch convention and event groups to include sales, negotiations and conflict resolution
  • Plan and develop programs, agendas, and services according to client requirements
  • Communicate all group specifications and history to the appropriate operational departments
  • Ensure that all specifications are implemented and executed to established guidelines
  • Partner with senior department leadership to implement process improvements designed to increase client satisfaction and operational efficiencies
  • Accurately forecast group revenues according to established guidelines
  • Promote the proper use of function space, exhibit hall and overall event space
  • Maximize group revenue by referring available goods, services, attractions, and sub-contractors to convention groups
  • Assist with the training and development initiatives for the Convention Services staff
  • Verify that advanced knowledge of conventions and meeting industry and familiarity with current trends are maintained throughout the department
  • Fulltime
Read More
Arrow Right
New

Senior Accountant

We are looking for a Senior Accountant to join our client in Lexington, Kentucky...
Location
Location
United States , Lexington
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Accounting
  • Minimum of 5 years of accounting experience, non-profit accounting knowledge is a plus
  • Advanced skills in Microsoft Office and exceptional attention to detail
  • Strong software skills including advanced Excel skills
Job Responsibility
Job Responsibility
  • Manage the general ledger, ensuring accurate recording of transactions and adherence to nonprofit accounting standards
  • Prepare detailed financial statements on a monthly, quarterly, and annual basis for both internal and external stakeholders
  • Reconcile bank and investment accounts to maintain the accuracy of financial data
  • Monitor and report on restricted and unrestricted funding, ensuring compliance with grant regulations at federal, state, and local levels
  • Collaborate with program managers to track budgets and analyze grant expenditures
  • Assist in the development of annual budgets and forecasts, providing insights into variances and financial performance
  • Support audit preparation by compiling schedules and documentation for financial and single audits
  • Enhance internal controls and accounting processes to improve efficiency and mitigate risks
  • Act as a financial resource for program staff, fostering collaboration and providing guidance
  • Take part in special projects and contribute to system improvements as needed
What we offer
What we offer
  • medical, vision, dental, and life and disability insurance
  • eligible to enroll in our company 401(k) plan
Read More
Arrow Right
New

Learning and Development Supervisor

We are currently seeking a creative talent - Full-time talented Learning & Devel...
Location
Location
Egypt , Cairo
Salary
Salary:
Not provided
fourseasons.com Logo
Four Seasons
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A university degree or equivalent experience
  • Proficiency in the English language
  • Minimum of one to two years of experience in a similar capacity
  • Background in either hotel operations or other high-level service environments or a similar learning-focused setting
Job Responsibility
Job Responsibility
  • Support the execution of the hotel’s Learning and Development plan in alignment with company standards and priorities
  • Assist in identifying training needs through performance evaluations, departmental feedback, and business priorities
  • Coordinate and facilitate onboarding and orientation sessions for new hires, ensuring a smooth integration into the organization
  • Maintain accurate and organized training records, files, and calendars to ensure compliance and accessibility
  • Collaborate with Department Heads and Learning Coaches to coordinate departmental training initiatives and support on-the-job learning
What we offer
What we offer
  • Competitive Salary, wages, and a comprehensive benefits package
  • Excellent Training and Development opportunities
  • Complimentary Dry Cleaning for Employee Uniforms
  • Employee Meals
  • Stays at FS properties (based on availability), with discounted meals
  • Comprehensive private medical insurance
  • Dental/disability/life insurance
  • Retirement benefits/pension
  • Fulltime
Read More
Arrow Right
New

Roving Personal Banker Northwest Vegas Valley District

Wells Fargo is seeking an Associate Roving Personal Banker (SAFE) for our Nation...
Location
Location
United States , Las Vegas; North Las Vegas
Salary
Salary:
21.00 - 28.00 USD / Hour
https://www.wellsfargo.com/ Logo
Wells Fargo
Expiration Date
March 02, 2026
Flip Icon
Requirements
Requirements
  • 6+ months of interacting with customers experience, or equivalent demonstrated through one or a combination of the following: work experience, training, military experience, education
  • Customer service focus with experience handling complex transactions across multiple systems
  • Experience proactively engaging with customers through outreach via phone or email
  • Ability to educate and connect customer to technology and share the value of mobile banking options
  • Ability to help customers succeed financially by offering introductions to additional team members as appropriate
  • Experience working with others on a team to meet customer needs
  • Experience fostering and developing strong customer relationships
  • Ability to build strong relationships with internal partners
  • Ability to follow policies, procedures, and regulations
  • Ability to identify potential fraud/risky accounts and take appropriate action to prevent loss
Job Responsibility
Job Responsibility
  • Provide support across a variety of branch locations within a specific geography where a banker or teller is out of the office or to temporarily cover vacancies
  • Be flexible and adaptable to changing priorities and new surroundings while meeting customer needs
  • Participate in delivery of exceptional customer experience by building relationships through proactive outreach as well as proposing appropriate products, services, and digital solutions to help customers succeed financially
  • Assist customers with basic requests related to opening new accounts, completing service requests, and submitting credit applications
  • Receive direction from managers and exercise judgement within defined policies and procedures
  • Develop understanding of bank products and services to connect to customers' needs
  • Interact with customers to demonstrate care and build relationships
  • Provide appropriate options for bank products and services to customer
  • Refer customers' financial needs to other bankers and partners as needed
What we offer
What we offer
  • Health benefits
  • 401(k) Plan
  • Paid time off
  • Disability benefits
  • Life insurance, critical illness insurance, and accident insurance
  • Parental leave
  • Critical caregiving leave
  • Discounts and savings
  • Commuter benefits
  • Tuition reimbursement
  • Fulltime
Read More
Arrow Right