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Warehouse Associate, Columbus - Flex
Macy's
Columbus, OH
…paid holidays. Grow your career with continuous learning and leadership development. Plus, build community by joining one of our Colleague Resource Groups and make a difference through our…
Added 19 mins ago
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Instructor, Alternative Teacher Certification (Part Time)- Adjunct Pool
United States
- Part-time
i. Review, evaluate, and revise program curricula and practices to assure compliance with professional standards, state-mandated guidelines and requirements of business/ industry, and…
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Field Supervisor/Mentor Alternative Teacher Certification (Part Time)- Adjunct Pool
United States
- Part-time
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Added 42 mins ago
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(USA) Store Manager - Supercenter
Walmart
NEW ROADS, LA
- $110,000 to $170,000 USD / year
…highperformance culture integrating and including Academy associates in leadership and store meetings and activities that supports associateengagement in the overall facility engaging the…
Added 42 mins ago
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(USA) Asset Protection Operations Coach
Walmart
SAN ANTONIO, TX
- $65,000 to $100,000 USD / year
Provides supervision and development opportunities for hourly associates by hiring training and mentoring of associates assigning duties settingclear expectations providing associate…
Added 43 mins ago
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Emerging Store Manager - SC
Walmart
SHAWNEE, OK
- $85,000 to $120,000 USD / year
This position is a developmental leadership role designed to prepare associates for potential Store Manager opportunities within the Walmart US
Added 43 mins ago
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(USA) Overnight Stocking Coach
Walmart
COLUMBUS, OH
- $65,000 to $100,000 USD / year
Provides supervision and development opportunities for hourly associates by hiring training and mentoring of associates assigning duties settingclear expectations providing associate…
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(USA) GM Coach
Walmart
CHEBOYGAN, MI
- $65,000 to $100,000 USD / year
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(USA) Overnight Stocking Coach, Non-Complex, Management
Walmart
CARTHAGE, TX
- $65,000 to $100,000 USD / year
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(USA) Personal Shopper Lead - Sam's
Sam's Club
LITTLETON, CO
- $25 to $33 USD / hour
…programs by training and providing resources to meet store associate needs assigning dutiesproviding feedback communicating goals and ensuring associate coverage at the ecommerce pickup…
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(USA) Front End Coach
Walmart
TALLAHASSEE, FL
- $65,000 to $100,000 USD / year
Provides supervision and development opportunities for hourly associates by hiring training and mentoring of associates assigning duties settingclear expectations providing associate…
Added 44 mins ago
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(USA) Overnight Stocking Coach, Non-Complex
Walmart
ARVADA, CO
- $65,000 to $100,000 USD / year
Provides supervision and development opportunities for hourly associates by hiring training and mentoring of associates assigning duties settingclear expectations providing associate…
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(USA) Fashion Coach
Walmart
MOUNT VERNON, IL
- $65,000 to $100,000 USD / year
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(USA) Coach/Ops Mgr Trainee
Walmart
COTTAGE GROVE, MN
- $31.25 to $38.46 USD / hour
Provides supervision and development opportunities for hourly associates by hiring training and mentoring of associates assigning duties settingclear expectations providing associate…
Added 44 mins ago
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Human Resource Office/Training Manager (Fashion, Grocery, Import, Regional, Returns, Sam's, Wm.Com)
Walmart
WESTAMPTON, NJ
- $72,050 to $108,000 USD / year
Communicate with or to individuals or groups verbally andor in writing eg customers suppliers associatesImplement the business plan for area of responsibility by communicating goals and…
Added 46 mins ago
Assistant Store Manager
Staples Canada
Norridge, IL
Full-time hours, generous paid time off, career development program and weekly pay
Added 53 mins ago
Program Manager Project Delivery OE
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Westerville, OH
In support of the North America growth agenda, the Program Manager. Manages the implementation of large, complex new business start-up projects. Supports Business Development by de-risking…
Added 1 hour ago
Admissions Representative
South University
Virginia Beach, VA
Bachelor’s degree in business or a related field and one year of successful admissions or sales experience, OR associate’s degree and three years of successful admissions or sales…
Added 1 hour ago
Admissions Representative
South University
Virginia Beach, VA
Bachelor’s degree in business or a related field and one year of successful admissions or sales experience, OR associate’s degree and three years of successful admissions or sales…
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Software/Web Developer (SharePoint) – TS/SCI required
GD Information Technology, Inc.
United States
Advance how our customers operate while you advance your career. Join GDIT as a Software/Web Developer (SharePoint) Associate and build an impactful career in enterprise IT, collaborating…
Added 1 hour ago
Program Manager of Peer Tutoring
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United States
The Program Manager will work in collaboration with the Associate Director of the Peer Tutoring Program to provide leadership, strategic direction, and operational oversight for the Peer…
Added 1 hour ago
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Actuary – Value-Based Care
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Remote, United States
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…models for VBC arrangements, analyze savings opportunities and program/vendor value, provide analytical support during external vendor negotiations, and partner with Medicare/Marketplace…
Added 1 hour ago
Rare Disease Key Account Manager - Rheumatology-Nephrology - Northeast
Amgen
Boston, MA
…centers, and sites of care to grow the overall rare disease business in the assigned accounts and market. The KAM diagnoses account-level barriers and executes targeted strategies that…
Added 1 hour ago
Key Account Manager - Neurology (Rare Disease) - Northeast
Amgen
Boston, MA
…centers, and sites of care to grow the overall rare disease business in the assigned accounts and market. The KAM diagnoses account-level barriers and executes targeted strategies that…
Added 1 hour ago
Account Manager/Specialty Account Manager -KRYSTEXXA (Rare Disease) - Boston N, MA
Amgen
Boston, MA
Develops a comprehensive and effective territory business plan aimed at achieving and exceeding annual sales goals established by commercial leadership.

Amgen

Sr Specialist Quality Compliance

West Greenwich, RI, United States

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Job details

Posting language: English
Posted: Nov 1, 2026

Original job description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission - to serve patients living with serious illnesses - drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. J

Sr Specialist QA - Compliance

What you will do

Let’s do this. Let’s change the world. In this vital role, you will provide site-level leadership for inspection readiness across both manufacturing facilities, driving a sustained state of readiness for regulatory inspections, corporate and internal audits, and customer audits. You will lead the development and execution of readiness strategies, establish clear governance and accountability, and influence cross-functional partners to identify and address risks before they affect inspection outcomes. As a primary site coordinator, you will oversee inspection logistics including schedules, rooms, escorts, subject matter expert support, document retrieval, communications, and daily inspection management while adapting plans and resources as inspection priorities evolve. This role requires sound judgment, decisive action, and the ability to pivot quickly in a dynamic environment, align leaders and teams under time-sensitive conditions, and escalate emerging issues with clear recommendations.

Key Responsibilities:

Partner across functions to maintain a continuous inspection-ready state for a multi-product GMP manufacturing operation.
Develop, maintain, and continuously improve site inspection readiness programs, tools, trackers, playbooks, and governance processes.
Coordinate cross-functional readiness plans for upcoming Health Authority inspections and major audits, including mock inspections, war-room preparation, document review, and interview readiness.
Support inspection and audit strategy for new product introductions to ensure new processes, facilities, systems, documents, and personnel are inspection ready prior to implementation and filing-related activities.
Ensure inspection-related commitments, actions, and deliverables are clearly assigned, tracked to completion, and escalated as needed.
Facilitate cross-functional alignment on inspection narratives, site presentations, supporting data packages, and response coordination.
Support preparation and maintenance of core inspection readiness content, including site overviews, facility maps, product flow summaries, SME rosters, document inventories, and inspection support tools.
Coordinate document management and retrieval processes to support efficient and controlled responses during inspections and audits.
Monitor readiness of quality systems and operational processes that are commonly scrutinized during inspections, including deviations, CAPAs, change control, risk management, complaints, training, validations, document management, and data integrity controls.
Identify gaps, risks, or weak points that may affect inspection outcomes and work with functional owners to drive timely remediation.
Facilitate and manage monthly management review
Support site self-assessments and gap assessments against cGMP requirements, internal standards, and regulatory inspection trends.
Develop and sustain close working relationships with internal stakeholders and external business partners, to ensure aligned and effective audit and inspection support.
Ensure lessons learned from prior inspections, audits, commitments, and industry enforcement actions are incorporated into site readiness activities.
Track regulatory commitments and support timely follow-up to ensure inspection observations, actions, and commitments are completed and sustainable.
Provide compliance support during inspections, including schedule management, room coordination, request tracking, communication support, and facilitation of cross-functional issue resolution.
Support drafting, coordination, and review of inspection responses and related action plans, as applicable.
Escalate significant quality, compliance, supply, and inspection readiness risks to site quality and senior leadership.
Support continual improvement initiatives that strengthen site quality culture, inspection readiness capability, and execution discipline.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a collaborative leader with these qualifications.

Basic Qualifications

High school diploma / GED and 12 years of regulatory compliance experience OR
Associate’s degree and 10 years of regulatory compliance experience OR
Bachelor’s degree and 6 years of regulatory compliance experience OR
Master’s degree and 4 years of regulatory compliance experience OR
Doctorate degree and 2 years of regulatory compliance experience

Preferred Qualifications

Bachelor’s Degree in Life Sciences or Engineering
7+ years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, data analysis, project management, and quality systems
Experience leading or coordinating inspection and audit activities, including managing information requests, preparing subject matter experts, supporting interviews, and coordinating inspection responses.
Experience with leading and/or participating in key roles to prepare for, execute and/or respond to outcomes from Health Authority inspections
Experience in auditing and/or defending processes, procedures and decisions during Health Authority inspections
Strong working knowledge of cGMP requirements and quality systems commonly assessed during inspections, including deviations, CAPAs, change control, training, validation, document management, and data integrity.
Demonstrated ability to work autonomously, present data in an organized and logical manner and an ability to communicate effectively
Demonstrated ability to identify compliance risks and readiness gaps, lead cross-functional remediation, and ensure actions are completed and sustained.
Experience managing staff and/or leading cross-functional teams, projects and/or programs
Thorough working knowledge of EU and US Good Manufacturing Practices (cGMPs)
Previous exposure to bulk drug substance manufacturing and quality assurance processes
Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

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. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

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More about this job

Skills

Regulatory compliance
Leadership
Inspection
Internal auditing
Logistics
Good manufacturing practices
Presentation skills
Document management
Quality control systems
Risk management
Communication skills
Quality assurance
Pharmaceutical industry
Data analysis
Project management
Auditing
Work independently
Manage quantitative data
Quality assurance methodologies
Problem solving
Compensation and benefits
Sales

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