QC Bioanalytical Specialist

MSD Ireland; Swords; On-site; CAD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a QC Bioanalytical Specialist to join its dynamic team. This role involves leading laboratory investigations, supporting analytical testing, and ensuring compliance with industry standards. As a subject matter expert, you will collaborate across departments to drive continuous improvement and uphold cGMP practices. If you are passionate about innovation in healthcare and have a strong background in laboratory techniques, this opportunity allows you to make a significant impact while working in a supportive and inclusive environment. Join us in our mission to invent solutions that enhance patient care.

Qualifications

• 4-7 years of experience in the pharmaceutical industry.
• Experience with laboratory testing and relevant analytical techniques.
• Knowledge of Six Sigma and Lean methodologies.

Responsibilities

• Lead technical laboratory incidents and investigations.
• Support routine analytical testing using various assays.
• Ensure compliance with SOPs and cGMP regulations.

Skills

HPLC

PCR

ELISA

Problem Solving

Communication Skills

Technical Writing

Education

Bachelor’s degree in Natural Science

Bachelor’s degree in Chemical Engineering

Bachelor’s degree in Biological Engineering

Tools

Empower 3

LIMS

SAP

Job description

Job Description

An amazing opportunity has arisen for a QC Bioanalytical Specialist at our Biotech Dublin site. The role reports to the QC Bioanalytical Manager. The QC bioanalytical analyst will lead laboratory investigations and serve as the subject matter expert for change controls on site. Strong communication skills are essential for collaboration across departments and working on various projects. The QC Bioanalytical team primarily handles testing of Raw Materials, Chemistry, Bioassay, DNA, and Stability samples.

What You Will Do

Bring energy, knowledge, innovation, and leadership to:

1. Lead technical Laboratory Incidents, Investigations, and Problem Solving.
2. Support routine analytical testing using assays such as HPLC, CE, UV, Compendial, PCR, and ELISA on Release, In-process, Raw Materials, and Stability samples.
3. Lead local change controls and act as a laboratory SME for network-wide changes impacting the lab.
4. Author, review, and approve technical documents including Protocols, Reports, and Procedures.
5. Participate in and lead Continuous Improvement and Laboratory Transformation projects.
6. Support Divisional, Regulatory, and EHS audits as an SME on site.
7. Play a key role in troubleshooting and escalation processes.
8. Calibrate and maintain designated laboratory instruments.
9. Adhere to practices aligned with pharmacopoeias, specifications, regulations, and industry standards.
10. Ensure all training is current for relevant job functions.
11. Maintain data integrity and compliance with SOPs, specifications, and cGMP regulations.
12. Uphold cGMP standards at all times.
13. Participate in safety programs and maintain good housekeeping and hygiene within the lab.

Qualifications and Experience

To excel in this role, you will need:

1. Bachelor’s degree or higher in Natural Science, Chemical Engineering, or Biological Engineering.
2. 4-7 years of experience in the pharmaceutical industry.
3. Experience with Laboratory testing and relevant analytical techniques.
4. Experience in technical writing (Investigations, Procedures, Change Controls).
5. Project participation and leadership experience.
6. Experience participating in audits as an SME.
7. Knowledge of Six Sigma, Lean methodologies, GMP practices, ICH guidelines, and pharmacopeial requirements.
8. Experience with laboratory software such as Empower 3, LIMS, SAP.

We are committed to 'Inventing for Life', keeping the patient at the heart of our work, and striving to find solutions for healthcare needs. We value diversity and inclusion, believing that diverse ideas foster innovation.

If you are ready to invent solutions, impact healthcare, and inspire your team, please apply today.