Sr. Quality Associate I, QC

Grifols, S.A; Clayton (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Grifols, S.A. is seeking a Sr. Quality Associate to support the Fibrinogen Transfer Project within the QC Biochemistry MD&V group. The role emphasizes immunology and tissue culture assays, test method development and validation, and contribution to regulatory submissions.

Experience with GMP environments is preferred; strong communication and data analysis skills are essential as is proficiency with instrument qualification and software validation.

Qualifications

• PhD in Biochemistry or Chemistry with minimal experience (Quality Associate II)
• MS in Biochemistry or Chemistry with 2 years relevant experience (Quality Associate II)
• BS in Biochemistry or Chemistry with 4 years relevant experience (Quality Associate II)
• PhD in Biochemistry or Chemistry with 1 year relevant experience (Quality Associate III)
• MS in Biochemistry or Chemistry with 3 years relevant experience (Quality Associate III)
• BS in Biochemistry or Chemistry with 5 years relevant experience (Quality Associate III)
• PhD in Biochemistry or Chemistry with 2 years relevant experience (Senior Quality Associate)
• MS in Biochemistry or Chemistry with 4 years relevant experience (Senior Quality Associate)
• BS in Biochemistry or Chemistry with 6 years relevant experience (Senior Quality Associate)

Responsibilities

• Support immunology and tissue culture assays in QC Biochemistry
• Develop, validate, transfer, and replace test methods
• Assist in assay automation to improve efficiency
• Prepare protocols and reports for regulatory submissions
• Write test procedures and validation reports
• Interpret data and contribute to investigations
• Participate in experimental design under senior staff guidance
• Ensure GMP-compliant documentation and software validation

Skills

Immunology

Immunochemistry

Biochemistry

Test method development

Validation studies

Instrument qualification

Regulatory submission docs

MS Word

Excel

JMP

Education

PhD Biochemistry

MS Biochemistry

BS Biochemistry

Tools

Instrument qualification software

Spreadsheet validation

Job description

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.

Hours: First Shift - Monday to Friday 8:00 am to 4:30 pm

Sr. Quality Associate

The primary area of responsibility will be the to support the Fibrinogen Transfer Project.

Experience with biochemistry and biology assays is strongly preferred. As a member of the Quality Control Biochemistry Methods Development & Validation group, the incumbent will perform or assist in the following:

• Biochemistry test method development, validation, transfer, and replacement
• Assay troubleshooting
• Instrument Qualification
• ICH test method validation status of test methods, and compliance issues related to QC Laboratories.

The incumbent will perform and implement validation studies for assay methods and prepare protocols and reports for such studies that are suitable for review by regulatory agencies.

The incumbent will assist in the replacement or transfer of test methods for improving assay performance and providing laboratory efficiency through assay automation of test methods currently utilized for product release/specification testing.

Documentation will include but is not limited to, writing test procedures, test method validation reports, method development reports, and investigation reports.

Skill requirements

• The incumbent must have hands on experience to support immunology and tissue culture assays for the QC Biochemistry laboratory and must have hands on experience in test method development and validation including preparing protocols and reports for such studies that are suitable for review by regulatory agencies.
• The incumbent must have assisted in the replacement of test methods for improving assay performance and providing laboratory efficiency through assay automation of test methods currently utilized for product release/specification testing.
• The incumbent must have demonstrated experience in the preparation of detailed technical reports including but not limited to test procedures, test method validation reports, method development reports, regulatory submission documents, and investigative reports.
• The incumbent is expected to participate in the design of experiments and interpretation of data obtained in the course of an investigation under the direction of QC Biochemistry MD&V senior staff and to strive to provide creative solutions to problems that may arise during an investigation.
• Experience within a GMP environment is strongly preferred.
• The individual’s scientific area of expertise should provide an understanding of immunology and/or immunochemistry and of analytical methods including ELISA, spectroscopic techniques, and tissue culture methods.
• The incumbent must have hands on experience with instrument qualification, software validation, and spreadsheet development and validation.
• Experience with protein analysis, purification, and characterization will be considered a plus.
• The incumbent must have strong oral and written communication skills, with the ability to effectively communicate ideas to people with varying degrees of technical understanding is essential.
• A strong working knowledge of statistical data analysis is preferred.
• Strong computer skills are essential, especially with MS Word, JMP, and Excel

Education Requirements

• The Quality Associate II (M06) requires a minimum of a PhD Biochemistry or Chemistrywith minimal experience. MS in Biochemistryor Chemistrywith a minimum of 2 years relevant experience. BS in Biochemistryor Chemistrywith a minimum of 4 years of relevant experience.
• The Quality Associate III (M07)requires a minimum of a PhD Biochemistryor Chemistryand 1-year of relevant experience. MS in Biochemistryor Chemistrywith a minimum of 3 years relevant experience. BS in Biochemistryor Chemistrywith a minimum of 5 years of relevant experience.
• Senior Quality Associate (M08) requires a minimum of a PH.D in Biochemistry or Chemistry and 2 years of relevant experience. MS in Biochemistry or Chemistry, and 4 years of relevant experience. BS in Biochemistry or Chemistry, and 6 years of relevant experience.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.