QC Chemistry Analyst – Biotech Quality & Compliance

Grifols Shared Services North America, Inc; Dublin; On-site; EUR 47,000 - 68,000; Full time

Benefits offered by this job

A highly competitive salary package

Group pension scheme - Company matches

Private medical insurance for the emp

Ongoing career development

Internal promotion focus

Education and professional development

Wellness and social initiatives

Job summary

Grifols is seeking a Quality Control (QC) Chemistry Analyst to work at the Grifols Worldwide Operations facility in Ireland. The role covers analysis of raw materials, in-process and finished products, with emphasis on protein and excipient characterization.

The candidate will ensure GMP compliance, participate in transfers and CAPAs, and support QA audits. A 2+ year background in analytical chemistry is essential.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry or closely related scientific field.
• Requires a minimum of 2 years of related experience.
• Knowledge of a wide array of analytical techniques/instruments including HPLC, Spectrophotometry and Electrophoresis.
• Knowledge of specific product analysis (e.g. IC, AA, GC, Flame-photometry and Kjeldahl techniques) desirable
• Knowledge of raw material analysis (e.g. Karl-Fischer, FT-IR and NIR techniques) desirable
• Experience with investigating Out of Specification and Out of Trends.
• Experience in method transfer and verification/validation desirable.
• Knowledge of analytical techniques for biologics or protein-based therapeutics desirable.
• Excellent verbal and written communication.
• Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
• Strong organizational, analytical and problem-solving skills.

Responsibilities

• Carry out raw material, in-process and finished product chemistry and immunochemistry analysis.
• In-process and finished product QC including protein and excipient analysis including analytical techniques such as Spectrophotometry, Immuno-electrophoresis, HPLC, GC, AA and Flame-photometry.
• Raw material QC including Karl-Fischer, FT-IR and NIR techniques.
• Ensure laboratory processes, equipment and services are installed, qualified and maintained appropriately.
• Participate in the verification, validation and technical transfer of analytical testing procedures.
• Ensure that all cGMP, company specifications and procedures are followed.
• Investigate Out of Specification (OOS) and Out of Trend (OOT) results as required.
• Participate in and responsible for QC related CAPA’s.
• Adhere to QC documentation system and prepare document change requests as required.
• Develop, improve and implement QC procedures, processes and systems.
• Support projects and continuous improvement initiatives within the Quality department and other functional areas.
• Participate in international project teams relating to QC and wider quality activities and travel maybe required.
• Adhere to safety standards to ensure a safe working environment while ensuring the laboratory is kept clean, tidy and safe at all times.
• Prepare for and support regulatory and internal inspections/audits.
• Provide hands-on guidance and training when needed.
• Ensures work area is maintained in a state of compliance and audit readiness.
• Flexibility and willingness to carry out shift work when required.

Skills

HPLC

Spectrophotometry

Electrophoresis

OOS investigation

OOT investigation

Method transfer

Biologics analysis

Communication

Team collaboration

Education

Bachelor's degree in Chemistry/Biochemistry

Job description

Grifols is seeking a Quality Control (QC) Chemistry Analyst to work at the Grifols Worldwide Operations facility in Ireland. The role covers analysis of raw materials, in-process and finished products, with emphasis on protein and excipient characterization.

The candidate will ensure GMP compliance, participate in transfers and CAPAs, and support QA audits. A 2+ year background in analytical chemistry is essential.