Senior QA Materials Compliance Specialist (Biologics)

Bristol Myers Squibb; Ireland; On-site; EUR 60,000 - 90,000; Full time

Job summary

BMS Cruiserath Biologics in Ireland is seeking a Senior Specialist, QA Compliance Materials Management to lead material qualification documentation and QA disposition, ensuring cGMP compliance across biologics manufacturing processes.

The role requires a BSc in science with 3+ years in QA within biologics/pharmaceutical environments, strong communication and time-management skills, and the ability to work both independently and in a matrixed team. A competitive package awaits.

Qualifications

• BSc in Science or related discipline with a minimum of 3 years’ QA or related experience in a Biologics or Pharmaceutical environment.
• A clear understanding of cGMP requirements for manufacturing and/or systems and compliance.
• Knowledge of material qualification and SAP would be a distinct advantage.
• Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix to meet accelerated timelines.
• Excellent communication and presentation skills are essential.
• Excellent time management and organizational skills along with a proven ability to multi-task.

Responsibilities

• Preparation, review and approval of Material Qualification Documentation.
• QA disposition of raw materials, level 1 & level 2 consumables.
• Authoring, review and approval of QA-related procedures.
• QA review, assessment and approval activities for Biologics Manufacture, including change controls, deviations/investigations, supplier investigations, CAPAs, supplier change notifications (SCN), TSE certificates and related documentation.
• Be a core team member of the QA Compliance Materials Management team engaging in other support activities as required.
• Support establishment of Operational Excellence initiatives (5S / Std Work / LSW / Kaizen / Problem Solving).

Skills

QA Compliance

cGMP

Material qualification

SAP knowledge

Communication skills

Time management

Education

BSc in Science or related discipline

Tools

SAP

Job description

BMS Cruiserath Biologics in Ireland is seeking a Senior Specialist, QA Compliance Materials Management to lead material qualification documentation and QA disposition, ensuring cGMP compliance across biologics manufacturing processes.

The role requires a BSc in science with 3+ years in QA within biologics/pharmaceutical environments, strong communication and time-management skills, and the ability to work both independently and in a matrixed team. A competitive package awaits.