Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Grifols Diagnostic Solutions in San Diego is seeking a Quality Intern for the summer. The Quality Intern will work with various groups within the Quality department to gain an understanding of compliance, complaints, internal audits, non-conformances, quality events, corrective and preventive actions, design change controls, quality control procedures, record reviews, and new product development review of protocols, reports and risk.

To succeed in this role, we are seeking individuals who recently finished (<6 months) with an undergraduate degree or degree near completion in any applicable Quality related field along with a minimum of 2+ years university experience.

Responsibilities

• Accessions, tests, and documents results for critical biological samples used in daily QC testing.

• Performs routine release testing utilizing blood typing gel methods or conventional immunohematology techniques cGMP.

• Performs blood typing methods of low to moderate complexity using instrumentation such as Sysmex Blood Analyzers, Grifols manual and/or automated blood typing gel platforms such as the DG Reader Net, Erytra or Eflexis. Performs analytical chemistry methods such as purity by titration and BCA methods utilizing UV/Vis Spectroscopy.

• Work with and assist Quality Assurance (QA) Compliance to gain an understanding of the change control process and to ensure site compliance to procedures and Regulations (ISO 13485, MDSAP and IVDR).

• Work with and assist QA Complaints team to learn procedures for receipt, review and reporting of complaints for assays and instruments.

• Assist and train on how to handle product non-conformances, quality events and corrrective and preventive actions.

• Assist and train on performing internal audits.

• Assist and train on performing quality control procedures, quality reviews of batch records, manufacturing documents, etc.

• Participate on new product development core teams, including interactions with personnel from other departments. Gain knowledge of standards and guidelines required to perform verification and validation studies.

• Work with risk assessment software to gain an understanding of how to perform risk analysis per ISO 14971.

• Attend meetings as needed.

• Provide a presentation at the end of the internship, including work performed, knowledge gained, and recommendations for future internships.

Knowledge, Skills, and Abilities

• Excellent oral and written communication skills

• Proficient with Microsoft Office Suites

• Strong ability to demonstrate time management, organization and prioritizing tasks

• Ability to work independently on multiple simultaneous projects and be flexible to changing priorities

• Strong attention to detail

• Basic knowledge of GMP/QSR requirements is a plus.

• Basic computer skills

Education

• Recently finished (<6 months) undergraduate degree or degree near completion in any applicable Quality related field

• Minimum of 2+ years university experience

Experience

Technical writing skills are a plus

Occupational Demand

Work is performed in an office environment with exposure to electrical office equipment. May occasionally enter Bio Risk Area. Exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

Pay Scale

The estimated pay scale for Quality Intern role based in San Diego, California is $20 per hour. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Req ID: 526568

Type:

Job Category: Quality