Inspection Readiness Manager Job at Amgen

Inspection Readiness Manager

In this vital role, you will lead GCP and IVDR Inspection Readiness and Preparat...

Location

United Kingdom , Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company
Experience of, or oversight of global clinical trial conduct
Experience driving and leading process development and /or improvement

Job Responsibility

Lead GCP and IVDR site inspection readiness and preparation activities, ensuring consistent execution and successful inspection outcomes
Manage inspection readiness tools, systems, materials, and regulatory inspection preparation processes
Drive continuous improvement initiatives by identifying quality trends, risks, and inspection learnings, and implementing effective solutions
Partner with the Inspection Readiness Support Team to advance study health, quality, and inspection readiness initiatives
Serve as a subject matter advisor on inspection readiness and support selected internal audit activities
Maintain inspection readiness SharePoint resources, inspection documentation repositories, and access management
Support the Inspection Readiness & Operational Quality Senior Manager in strategic and operational activities
Mentor and develop student interns

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 Manager, Inspection Management

Location

United States , Cambridge

Salary:

130800.00 - 209400.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

BS/BA, MS or PhD and a minimum of 10, 8, 6 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.
Knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable international GxP regulations, guidelines and local legislation.
Knowledge of relevant FDA, EU, guidance for computerized systems is a plus.
Experience with inspection coordination and logistical planning for regulatory authority inspections.
Experience with work in the Regulatory Intelligence area.
Experience developing responses to regulatory authority inspection findings.
Experience working with CROs, vendors, and relationship management.
Leadership skills with ability to effectively organize and execute tasks
Ability to interact effectively with all levels within the organization.
Ability to work both independently and in a team environment.

Job Responsibility

Build and maintain strong and productive relationships with key stakeholders within R&D to support the successful and compliant execution of Moderna regulatory inspection activities.
Maintain in-depth knowledge of governmental regulations affecting GCP, GVP, GLP in the drug development process.
Plan, and coordinate GCP, GVP, GLP, GCLP regulatory authority inspections (routine, directed or submission driven) and the pre-inspection request process.
Coordinate and manage inspection readiness and preparation activities such as inspection management trainings, mock inspection interviews, mock inspections, site risk assessments and clinical site inspection preparation visits in preparation for regulatory authority inspections.
Provide guidance and direction in development of responses to observations resulting from inspections of Moderna’s R&D programs.
Ensure any critical and major inspection findings have appropriate Corrective and Preventative Actions (CAPA) and are tracked to completion and verification of effectiveness.
Lead and manage post-inspection lesson’s learned sessions, ensuring all actions are tracked to completion.
Contribute to and maintain inspection management plans, trainings, and strategies for the R&D Quality inspection management program.
Review and provide input into study team inspection preparation activities, storyboards, etc.
Collaborate with industry through benchmarking of regulatory activities that may influence regulatory inspection activities and strategies.

What we offer

Best-in-class healthcare coverage, 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 planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras

Fulltime

Engineering Manager – F&E Readiness

Amgen Dun Laoghaire (ADL) is developing a next-generation, technologically advan...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related discipline)
Experience (typically 5+ years) in engineering roles within a cGMP biopharmaceutical manufacturing environment
Experience in developing strategies for new product introduction and new technology deployment
Strong knowledge of, Equipment lifecycle management, Maintenance and reliability systems, GMP compliance, validation, and regulatory expectations
Proven ability to lead, build and develop teams, including working cross-functionally and managing complex stakeholder environments
Project management, problem-solving and decision-making capability
Excellent communication and technical writing skills

Job Responsibility

Act as the F&E representative within the capital project team, ensuring site requirements are embedded in facility and equipment design
Provide technical input and review of design deliverables (layouts, P&IDs, URS, specifications, automation strategies, maintenance concepts)
Ensure alignment with Amgen global standards, corporate blueprints and site operational requirements
Partner with Global Engineering, CQV, Automation, Quality and Operations to ensure a fully integrated and operable facility design
Identify and mitigate operability, maintainability and reliability risks early
Define and develop the F&E readiness strategy, including: Maintenance strategy and asset lifecycle plans
Spare parts and criticality assessments
Reliability and performance frameworks (OEE, predictive maintenance)
Establish systems to ensure equipment reliability and lifecycle ownership aligned with site expectations
Drive implementation of predictive and preventative maintenance philosophies from design through operation

What we offer

competitive salary
comprehensive Total Rewards Plan including health, financial and career development benefits

New

Inventory Clerk

We are looking for a detail-oriented Inventory Clerk to join our team in Frankli...

Location

United States , Franklin

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Previous experience in inventory control, shipping and receiving, or materials handling within an office, laboratory, or regulated environment
Working knowledge of inventory tracking practices, asset inventory processes, and physical inventory accuracy standards
Strong attention to detail with the ability to maintain precise documentation and follow chain-of-custody requirements
Comfortable using computer systems for data entry, shipment logging, and inventory record maintenance
Ability to manage materials with special storage or transportation conditions, including temperature-sensitive items
Effective communication skills and the ability to coordinate with multiple stakeholders in a team-based setting
Availability to work onsite in Franklin, Indiana five days per week with flexibility for an early start when needed

Job Responsibility

Receive incoming materials from internal departments, sponsors, and outside partners, ensuring each item is documented correctly upon arrival
Open, inspect, and verify shipments against supporting records to confirm quantities, condition, and required handling instructions
Enter inventory details into computer systems to maintain accurate tracking, traceability, and chain-of-custody documentation
Pull, organize, and prepare sample inventory for testing activities while following proper handling procedures for temperature-sensitive materials, including dry ice shipments
Coordinate outgoing shipments by packaging, organizing, and releasing materials for domestic delivery in alignment with schedule and documentation requirements
Communicate inventory issues, discrepancies, or receiving challenges to project coordinators and other team members to support timely resolution
Maintain orderly storage areas and help monitor material movement so inventory remains accessible, accurate, and audit-ready
Work closely with onsite team members during training and daily operations to provide coverage and ensure continuity of material management processes

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

Fulltime

Pharmacy Intern

You’ve invested a lot of time and energy in your education. Now you want the cha...

Location

United States , Tampa

Salary:

20.00 - 23.75 USD / Hour

CVS Health

Expiration Date

August 04, 2026

Requirements

Accepted into, or actively enrolled in, an ACPE accredited college or school of pharmacy
Must possess, or be in the process of obtaining, valid intern and/or technician licensure as required
Regular and predictable attendance, including nights and weekends
Ability to complete required training within designated timeframe
Attention and Focus: Ability to concentrate on a task over a period of time
Ability to pivot quickly from one task to another to meet patient and business needs
Ability to confirm prescription information and label accuracy, ensuring patient safety
Customer Service and Team Orientation: Actively look for ways to help people, and do so in a friendly manner
Notice and understand patients’ reactions, and respond appropriately
Communication Skills: Use and understand verbal and written communication to interact with patients and colleagues

Job Responsibility

Applying didactic learning from pharmacy school into real-world practice to become ready for a Pharmacist role
Completing a comprehensive training roadmap designed to show you first-hand what it’s like to be part of a pharmacy team while gaining an overview of store, district, and regional operations
Assisting the pharmacy team to ensure that pharmacy operations run smoothly, our patients’ prescriptions are filled promptly, safely, and accurately, and we are providing caring service that exceeds patient expectations
Learning to operate as part of the pharmacy team through consistent application of Standard Operating Procedures (SOPs), best practices, and effective communication
Demonstrating empathy and genuine care, and contributing to a safe and inclusive culture where all people feel valued and empowered
Living our purpose by following all company SOPs at each workstation to help our Pharmacists and Technicians manage and improve patient health
Following pharmacy workflow procedures at each pharmacy workstation (i.e., production, pick-up, drive-thru, and drop-off) for safe and accurate prescription fulfillment
Contributing to positive patient experiences showing empathy and genuine care
Offering to counsel, fielding medical questions, and soliciting information on a patient’s medical history to provide optimal care, when appropriate under the direct supervision of a licensed pharmacist
Taking telephonic prescriptions from the prescriber, and calling the prescriber to clarify prescriptions or facilitate medication changes, where allowed by state regulation

What we offer

Dental
Vision
Wellness resources
Employee discounts
Access to certain voluntary benefits
Other programs

Parttime

Alterations Customer Service Representative

The Alterations Customer Service Representative (CSR) is a critical role for the...

Location

United States , Rockville

Salary:

17.00 - 18.00 USD / Hour

David's Bridal

Expiration Date

Until further notice

Requirements

High school diploma or equivalent degree
1-2 years prior retail experience in an apparel or specialty store environment
Prior sewing experience is helpful
Prior experience with computerized POS (Point of Sale) system

Job Responsibility

Welcome all customers with genuine, and friendly enthusiasm over the phone, virtual chats and in person, communicates clearly and concisely adapting style to suit customers by problem solving, excellent phone skills and resolving conflict
Use all systems to manage the customer flow to deliver five-star customer experience
Meet all service vows including, Prepare, Welcome, Meet Needs & Be There for all customers, includes all operational checklist task and meeting customers emotional and practical needs
Responsible for providing an exceptional service experience to multiple customers at one time and contributes to the store achievement of Five-Star Customer Service
Proactively address customer concerns with confidence
Effectively communicate how alterations can play an important role in perfecting the dress for her event in partnership with Alterations
Promote all alterations services and personalization options
Maintain store-standards (clean, organized, promotional readiness, store recovery) to support a flawless shopping experience
Maintain high dress code standards as required by the Dress Code policy
Greet and escort all alterations customers to and from alterations for appointments

What we offer

Rewarding Environment and Competitive Pay
Team Bonus
Dayforce Wallet – Get Paid Early
Generous Team Member Discount After First Pay Period
Vision Care
Supplemental Insurances- Critical Illness, Hospital Indemnity and Accidental Injury
401K Program
Discount for Identity Theft Protection
Discounts for Home and Auto Insurance
Discounts for Mobile

Parttime

Lead Cashier

Experience a place of energy, passion, and excitement. A place where the joy of ...

Location

United States , Culver City

Salary:

17.50 - 26.00 USD / Hour

Ulta Beauty

Expiration Date

Until further notice

Requirements

High school diploma is preferred
2 years of relevant work experience or equivalent combination of education and relevant work experience preferred
Proven ability to delegate, multi-task, and problem-solve
Demonstrated knowledge and passion for guest service and a competency for selling
Experience addressing guests concerns and questions promptly and professionally to deliver exceptional customer service
Demonstrated experience in exceeding sales goals and training new hires
Proficient with basic technology (e.g., Point of Sale system and Apple devices)
Excellent written and verbal communication
Strong collaboration and interpersonal skills
Ability to work independently and as part of a team

Job Responsibility

Contribute to meeting or exceeding the store's goals related to retail and service sales, omni-channel, guest loyalty (including credit), and retail shrink as set by Ulta Beauty for the store
Ensure that each guest receives exceptional service by providing a guest-friendly environment, which includes greeting and engaging each guest, personalizing service to their needs, and recommending Ulta Beauty products and/or services
Courteously handle sales, refunds, and exchanges
Ensure each guest receives exceptional service by pairing them with an associate to perform makeup applications, skincare analysis, and product demonstrations to drive sales and the guest service experience
Book appointments for and support the execution of services and in-store events that deliver an unrivaled guest experience while delivering on sales goals
Take ownership over the replenishment, organization, and maintenance of all cashwrap displays, supplies, and impulse fixtures to ensure guest-readiness at all times
Maintain prompt, regular attendance
Contribute to an inclusive environment that supports teammates, peers, and the internal and external guests served
Support the leadership team by completing cashier chat ins and chat outs as well as associate exit inspections as needed
Take the initiative to stay informed regarding new and existing industry trends, products, and services during work time, and be knowledgeable about the ingredients and benefits of these trends, products, and services to better serve guests

What we offer

Paid time off
Health insurance
Dental insurance
Vision insurance
Life insurance
Disability benefits

Parttime

Senior Engineer

We are currently recruiting for a Senior Engineer to join a tier-one joint ventu...

Location

United Kingdom , Plymouth

Salary:

300.00 - 480.00 GBP / Day

Randstad

Expiration Date

July 10, 2026

Requirements

Heavy Civils / Marine Expertise: A strong background as a Senior Engineer or experienced Section Engineer on major infrastructure schemes (e.g., docks, marine, piling, or heavy concrete structures).
Security Clearance: Ability to obtain or currently hold relevant UK security clearance (due to the defence nature of the facility).
Technical Qualification: A degree or HND/HNC in Civil Engineering or a related engineering discipline.
Site Ready: A valid CSCS card, SMSTS, and First Aid at Work certificate.
Precision & Quality Focused: Proven experience managing quality control, ITPs, and accurate as-built records within highly regulated environments.

Job Responsibility

Managing and overseeing setting out, dimensional control, and engineering accuracy for major marine and heavy civil packages.
Supervising and mentoring site engineers, direct labor, and specialist subcontractors to ensure safe and efficient delivery.
Enforcing impeccable safety, quality, and environmental standards, including the review and writing of RAMS and Inspection Test Plans (ITPs).
Coordinating temporary works requirements, managing the design interface, and resolving technical queries (RFIs) on site.
Tracking progress against the master schedule, managing daily site records, and collaborating with the project management team on short-term programming.

What we offer

Lodging allowance

Fulltime

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Inspection Readiness Manager

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