34236-QC Associate, Bioanalytical Sciences-Dublin Contractor

This is a 12-month initial contract.

Purpose:
Under minimal supervision, perform QC activities including reagent/media preparation, GMP documentation review, sample/data management, and analytical testing. Support continuous improvement, compliance, and Right First Time (RFT) initiatives.

 Responsibilities:

• Perform and review routine QC testing (e.g., Cell-Based Potency Bioassays, Immunoassays) with accuracy.
• Review, approve, and archive analytical data per GMP standards.
• Troubleshoot lab issues and communicate with stakeholders.
• Support audits, investigations, and regulatory filings.
• Identify and drive process improvements.
• Train others and provide technical guidance as needed.

Requirements:

• Bachelor’s degree in a science discipline.
• 1-2 years of biopharmaceutical QC or GMP lab experience.
• Knowledge of GMP/regulatory compliance (FDA/EMA).
• Experience with analytical techniques (e.g., cell culture, aseptic technique).
• Strong technical writing (SOPs, investigations) and communication skills.
• Ability to work independently and escalate issues proactively.

Preferred Skills:

• Leadership/coaching experience.
• Project management and organizational abilities.
• Interaction with regulatory agencies.

Work Environment:

• Lab-based role with minimal supervision.
• Follows procedures while applying technical judgment.
• May set project priorities and escalate challenges.