▷ Only 24h Left Senior Specialist, QC Quality Systems

6 days ago

Dublin Pike, Ireland Bristol-Myers Squibb Co Full time

Join to apply for the Senior Specialist, QC Quality Systems role at Bristol Myers Squibb.

The Role
BMS Cruiserath Biologics is seeking to recruit a Permanent Senior Specialist, QC Quality Systems (Lead Investigator), reporting to the QC Quality Systems Team Lead. The QC Quality Systems Specialist will be part of a team responsible for supporting the Quality Control team with Investigations and Change Controls.

Key Duties And Responsibilities

Lead and manage QC Investigations assigned

Facilitate root cause analysis and problem solving sessions

Complete the generation of associated investigation reports

Determine and create CAPA's, Effectiveness Reviews, and Supplemental Tasks as required

Present investigations at IRB to senior management

Lead and coordinate the initiation, implementation, and closure of QC Change Controls

Ensure the timely completion of all activities related to these quality systems

Collate metrics/KPI's and generate associated dashboard read‐out

Communicate with BMS local and global stakeholders

Lead huddles, meetings, conference calls and provide read‑outs

Participate in the OpEx strategy and support process improvements

Participate in internal and external audits

Support additional QC analytical services activities, as required

Qualifications, Knowledge and Skills Required

Proficiency in communication and collaboration at a variety of levels

Proven success working well in a team environment with flexibility to react to changing business needs

Demonstrated problem solving, project management ability

Excellent time management and organizational skills

Excellent technical writing skills

Previous investigations experience is an asset

Ability to research and have an excellent understanding of new areas/tasks/assays under investigation promptly

Education minimum of a B.Sc. Biochemistry or related discipline

At least 3 years' experience, in a GMP laboratory setting ideally within a biologics laboratory

A minimum of 1 year experience with demonstrated effectiveness using quality systems (investigations/change controls – Trackwise/Infinity) in an FDA and EMA regulated environment

Knowledge of biologics QC testing (Separations, Bioanalytical, Microbiology or Raw Materials) is desirable

Why you should apply

You will help patients in their fight against serious diseases

You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees

You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical assurance, 27 day annual leave, life assurance and on‑site gym

Seniority level
Associate

Employment type
Full‑time

Job function
Quality Assurance

Industries
Pharmaceutical Manufacturing

Read more: careers.bms.com/working-with-us

BMS is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or veteran status.

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