Job Description
QA Manufacturing Compliance Specialist (Biologics)
Job Department: Quality Assurance
Reports to: Quality Operations Manager
About the Role
Our client, a leading pharmaceutical company, is seeking a QA Manufacturing Compliance Specialist to join their biologics team. This role ensures all products meet quality standards for marketed and investigational drug products. If you are passionate about quality assurance in biologics, this opportunity is for you.
Key Responsibilities
- Ensure products meet regulatory, company, and user requirements.
- Oversee compliance within Operations, ensuring adherence to site policies and procedures.
- Monitor aseptic product processing and conduct intervention observations.
- Lead and assist in investigations related to non-compliance.
- Review batch records, manufacturing logs, and operational documentation.
- Perform line clearance and raw material checks.
- Support stability programs and manage finished product status.
- Manage quality logs and conduct daily walk-arounds in manufacturing areas.
- Drive continuous improvement in compliance processes.
Requirements
- Degree in science, quality, or engineering.
- Minimum of three years' experience in a GMP-regulated quality or operations role.
- Experience in biologics manufacturing and aseptic processing is a plus.
- Strong regulatory knowledge.
Key Competencies
- Attention to detail and strong adherence to procedures.
- Problem-solving skills and adaptability.
- Results-driven and committed to quality.
- Strong communication and interpersonal skills.
- High integrity and work ethic.
Ownership and Accountability
- Commitment to the AbbVie Vision and Strategic Imperatives.
- Ability to work independently with a Right First Time approach.
- Manage day-to-day quality operations, ensuring cGMP, HPRA, and FDA compliance.
Leadership and Decision-Making
- Support cross-functional projects.
- Influence operational quality actions and maintain compliance.
- Serve as a compliance SME and handle daily quality issues, escalating major concerns when needed.
Environmental, Health, and Safety (EHS) Responsibilities
- Adhere to EHS policies and best practices.
- Report EHS incidents and participate in safety training.
- Wear appropriate PPE as required.
Why Join Us in Sligo?
County Sligo offers a vibrant community and exceptional quality of life, combining beautiful natural landscapes with a rich cultural heritage—ideal for both career growth and personal enjoyment.