Specialist QA - Deviation/CAPA Site SME

Juncos, PR, US
Oct 30, 2020
Required Education
Bachelors Degree
Position Type
Full time
Are you looking for a meaningful new opportunity to test and growth your Quality Assurance skills? We have an immediate need for a SPECIALIST QUALITY ASSURANCE. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our Amgen Manufacturing Limited Operations in Juncos, Puerto Rico.

The Role

The Quality Assurance Specialist is responsible for day to day quality system oversight in a dynamic environment that produces commercial drug substance, drug product and combination products at the Amgen Manufacturing, Limited facility. Responsibilities within the role will include provide Quality Management System (QMS) process subject matter expertise for Deviation and CAPA management. Ensuring the investigations and prescribed corrective and preventative actions are complete and robust following the established processes to assure the safety and quality of Amgen products.

  • Quality Management System (QMS) Subject Matter Authority (SME)
  • QA Specialist serves as AML SME for Deviation and Corrective Action Preventive Action processes within the Amgen QMS.
  • Represents Amgen Manufacturing, Limited (AML) at Global Amgen networks and Collaboration Groups to fulfill the role of QMS "Site SME"
  • Provides as Certified Instructor for trainings related to the QMS processes from the area of expertise.
  • Quality Oversight
  • Ensures the Quality Management System processes are executed in accordance with established standards and procedures.
  • Provides direction and decision making for Quality system records and reports such as Deviations, Corrective Actions/Preventive Actions (CAPAs) and CAPA Efficiency Verification.
  • Reviews and approves records and reports. May serve as record or report owner.
  • Collaborates cross functionally and across the Amgen Enterprise / Network to ensure the Quality Management System processes are implemented, maintained, and executed in accordance with established procedures and applicable regulatory expectations.
  • Continuous Improvement
  • Serves as a team member with cross-functional colleagues on improvement initiatives, regulatory inspection readiness activities, and internal audits.
  • Will work directly with regulatory agencies during on-site inspections.
  • Collaborates with cross functional staff and colleagues to achieve the objectives of the company in a safe and compliant manner.
  • Communicate effectively with all levels of the organization.
  • Assess, develop, measure and interpret process performance indicators or metrics to monitor the health of the QMS process.

Basic qualifications:

Doctorate degree


Master's degree and 3 years of Quality and/or Operations experience in GMP regulated environment


Bachelor's degree and 5 years of Quality and/or Operations experience in GMP regulated environment

Preferred Qualifications
  • Educational background in Life Science or Engineering
  • Availability for Non Standard shifts
  • Validated expertise in Quality Systems such as Non Conformance, CAPA, and Change Control
  • Experience in electronic systems such as: Maximo, ARMS, Trackwise, LIMS and SAP
  • Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background Technical proficiency)
  • Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development
  • Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements
  • Validated experience as Quality Contact for complex projects involving packaging, inspection, and new products
  • Validated experience in Commissioning and Qualification
  • Strong organizational skills, including ability to follow assignments through to completion
  • Enhanced skills in leading, influencing and negotiating
  • Demonstrate ability to interact with regulatory agencies
  • Solid word processing, presentation, database and spreadsheet application skills
  • Strong communication (both written and oral), facilitation and presentation skills
  • Validated skill in working independently and to effectively interact with all levels throughout the organization
  • Advanced data trending and evaluation
  • Ability to evaluate compliance issues

The benefits

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer an outstanding benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site childcare and fitness facilities - you will find us passionate about your well-being too

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.