Senior Associate- Quality Assurance Validation

1 month ago

Holly Springs, United States BioSpace, Inc. Full time
Job Details

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate- Quality Assurance Validation (QAV)

What you will do

Lets do this Lets change the world

The Quality Assurance Senior Associate is a vital role for ensuring quality and compliance are built into the new Amgen North Carolina (ANC) facility from the start. The initial focus of the role will be to provide quality support of the commissioning & qualification and process qualification of the facility, utilities, computer systems and equipment. You will collaborate cross-functionally to ensure project timelines and milestones are met. Once the site is operational, this role will continue to provide validation support, as well as quality support for all non-manufacturing functions (such as Facilities/Engineering, Supply Chain, Quality Control) and their associated processes, changes, deviations, CAPAs, and capital projects.
  • Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site, as well as periodic reviews and other core day-to-day- tasks. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance.
  • Perform quality review and approval of documents to support facility commissioning and qualification, according to project timelines.
  • Provide quality support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies, as required.
  • Review and approve controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports, Work Instructions, Forms, etc.
  • Provide quality assistance on quality records including deviations/CAPAs, change controls and work orders ensuring adherence to procedural requirements and confirming assessments and evaluations of different stakeholders are complete and accurate.
  • Ensure that all activities & related documentation for facilities, equipment, materials, and processes comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
  • Support on-site audits and inspections.
  • Support continuous improvement initiatives.
  • In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
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 flexible, and driven individual with these qualifications.

Basic Qualifications:
  • High school/GED + 4 years Quality and/or Operations experience OR
  • Associates + 2 years Quality and/or Operations experience OR
  • Bachelors + 6 months Quality and/or Operations experience OR
  • Masters degree
Preferred Qualifications:
  • Understanding of regulatory requirements, trends, and industry standards.
  • Experience/knowledge in commissioning/qualification/validation, including computer-systems validation.
  • Excellent written and verbal communication skills.
  • Ability to work in a team matrix environment and build relationships with partners.
  • Great attention to detail and high degree of accuracy in task execution and GMP documentation.
  • Ability to complete tasks autonomously, providing updates to senior management, identifying potential issues, and following assignments through to completion.
  • Proven capability and experience applying GMP requirements in an operational and Quality Control setting.
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, well 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, including remote and hybrid work arrangements, where possible


Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, 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 and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

  • Senior Associate Quality Assurance Specialist

    3 weeks ago

    Holly Springs, United States Amgen Full time

    About AmgenAt Amgen, we're driven by our mission to serve patients living with serious illnesses. Our shared purpose guides everything we do, from researching innovative medicines to delivering them to those who need them most.We've been a leader in the biotech industry since 1980, helping pioneer treatments for some of the world's toughest diseases. With a...

  • Quality Assurance Senior Associate

    19 hours ago

    Holly Springs, United States Randstad Life Sciences Full time

    Job DescriptionJob DescriptionTitle: Quality Assurance Senior AssociateDuration: 1 YearLocation: Holly Springs, NC 27540Pay Rate: $35/hr on W2  Job Details:The role will support the inspection, sampling, and testing of raw materials that are received at the Company’s North Carolina site. This role will ensure that raw materials received for use in our...

  • Senior Associate Quality Assurance

    4 weeks ago

    Holly Springs, United States Amgen Full time

    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. With our focus on four...

  • Quality Assurance Specialist

    3 weeks ago

    Holly Springs, United States BioSpace, Inc. Full time

    About the RoleAmgen, a biotech pioneer in oncology, inflammation, general medicine, and rare diseases, seeks an experienced Quality Assurance Specialist to lead commissioning and qualification efforts at its North Carolina facility. As a Senior Validation Associate, you will ensure quality and compliance are built into the new site from the start,...

  • Quality Assurance Manager

    3 weeks ago

    Holly Springs, United States National Guard Employment Network Full time

    About National Guard Employment Network">We are a leading organization dedicated to serving patients living with serious illnesses. Our mission is to develop innovative medicines that take care of others, while also caring for the professional and personal growth and well-being of our employees.">Job Description">The Senior Associate I in Quality Assurance...

  • Quality Assurance Engineer

    15 hours ago

    Holly Springs, United States Intellectt Inc Full time

    We are seeking a highly skilled Quality Assurance Engineer to join our team at Intellectt Inc.The ideal candidate will have experience with quality assurance, validation, and regulatory compliance.Responsibilities:Develop and execute quality assurance procedures and validation protocols.Analyze data and present conclusions to ensure compliance with cGMP...

  • Validation Lifecycle Expert

    2 weeks ago

    Holly Springs, United States Validation & Engineering Group Full time

    Responsibilities:Design and execute validation plans for computerized systems within biotech labs and manufacturing environments.Perform risk assessments to prioritize system validation based on impact to patient safety, product quality, and regulatory compliance.Prepare and maintain detailed documentation for validation activities, including validation...

  • Quality Systems Manager

    3 weeks ago

    Holly Springs, United States Amgen Full time

    About Amgen: A Leader in BiotechFor over four decades, Amgen has been dedicated to improving the lives of people around the world. We've pioneered treatments for serious diseases, such as cancer and rare disorders, and continue to innovate through cutting-edge research and development.We're passionate about serving patients, and our commitment to excellence...

  • Associate Quality Assurance

    1 month ago

    Holly Springs, United States ApTask Full time

    About Client: The client is one of the world's largest independent biotechnology companies, focusing on the discovery, development, and manufacturing of innovative human therapeutics. The company's areas of expertise include oncology, hematology, cardiovascular disease, inflammation, bone health, and neuroscience. It has developed a wide range of biologic...

  • Validation Lifecycle Management Expert

    4 weeks ago

    Holly Springs, United States Validation & Engineering Group Full time

    **Job Description:**We are seeking a highly skilled Computer Systems Compliance Specialist to join our team at Validation & Engineering Group. The ideal candidate will possess a strong understanding of biotechnology industry regulations and compliance principles.Key Responsibilities:Design and execute validation plans for computerized systems in biotech labs...

  • Senior Associate Quality Assurance

    4 weeks ago

    Holly Springs, United States VetJobs Full time

    Job Description ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set,...

  • Quality Assurance Specialist

    11 hours ago

    Holly Springs, North Carolina, United States Volt Full time

    Job Summary: We are seeking a highly skilled Quality Assurance Specialist to join our team at Innova Solutions. The ideal candidate will have extensive experience in analytical method validation, technical documentation, and quality risk assessments.

  • Quality Assurance Specialist

    3 weeks ago

    Holly Springs, United States Food Lion Full time

    Company OverviewAt Food Lion, we value our associates as our most important assets. Our goal is to provide a meaningful career full of variety and challenges, where each associate contributes to the overall success of the company.SalaryWe offer an estimated salary range of $45,000 - $65,000 per year, depending on experience and qualifications.Job...

  • Quality Assurance Specialist

    3 weeks ago

    Holly Springs, United States Food Lion Full time

    Company OverviewAt Food Lion, we recognize the importance of our Associates in driving our success. We strive to provide a fulfilling work experience and reward performance and commitment.We are committed to the professional development of our Associates through on-the-job learning opportunities and training.The ideal candidate will be passionate about...

  • Quality Assurance Specialist

    3 weeks ago

    Holly Springs, United States Food Lion Full time

    Company OverviewAt Food Lion, we value our associates as the driving force behind our organization's success. We strive to provide a fulfilling work experience and reward performance and commitment through various learning opportunities and training programs.Estimated Salary$45,000 - $55,000 per yearJob DescriptionWe are seeking a part-time Quality Assurance...

  • Quality Assurance Specialist

    3 weeks ago

    Holly Springs, United States Oxford Global Resources Full time

    Job Overview:Oxford Global Resources is seeking a Quality Assurance Specialist to perform tactical work and review various documents, protocols, and reports to ensure compliance with regulatory requirements.About the Role:Review and approve manufacturing records, change controls, investigations, and analytical dataReview and approve test methods and method...

  • Associate Quality Assurance

    1 month ago

    Holly Springs, United States ADVANCED BIO-LOGIC SOLUTIONS Full time

    Description: Note: Candidates must live within 30 miles site in Holly Springs, NC Job Details: The role will support the inspection, sampling, and testing of raw materials that are received at the North Carolina (ANC) site. This role will ensure that raw materials received for use in our cGMP manufacturing plants meet all specification requirements and...

  • Part-Time Quality Assurance Specialist

    3 weeks ago

    Holly Springs, United States Food Lion Full time

    **Why Work at Food Lion?**We are committed to creating a workplace culture that values diversity, equity, and inclusion. Our goal is to attract and retain top talent from a wide range of backgrounds and perspectives.As a PT Quality Assurance Associate, you will have the opportunity to make a meaningful contribution to our organization while developing your...

  • Quality Assurance Specialist

    13 hours ago

    Holly Springs, United States The Steely Group Full time

    Job DescriptionThe Steely Group is seeking a detail-oriented and organized Quality Assurance Specialist to join our team. In this role, you will be responsible for performing routine sampling and testing in a GMP Manufacturing facility.Main Responsibilities:Assist with environmental monitoring performance qualificationsExecute routine sample collection for...

  • Senior Quality Assurance Manager

    4 weeks ago

    Blue Springs, Mississippi, United States TRIGO Global Quality Solutions Full time

    Job Overview:A Team Lead Position is available at TRIGO Global Quality Solutions in Blue Springs, MS. This role ensures customer satisfaction by providing quality services and support. The ideal candidate will provide leadership and guidance to site personnel while maintaining a positive atmosphere.Responsibilities:Establish and maintain relationships with...