Job Title: Quality Control Specialist
About Us
Hiring for a Quality Control Specialist for a GMP Laboratory located in Cork City. Analysts with minimum two-three years experience working with HPLC and other chemistry methods please apply.
*Accommodation available in Cork and Full Working rights needed*
Responsibilities & Duties
- Regulatory Compliance: Ensure strict adherence to cGMP, GLP, and Environmental, Health & Safety (EHS) regulations.
- Testing & Release: Execute all routine Quality Control activities and testing required to support the timely, compliant launch and release of finished products.
- Exception Management: Execute and manage the finished product Exception Program.
- Method & Validation: Prepare and execute method development activities, validation plans, and laboratory protocols.
- Equipment Maintenance: Ensure all laboratory equipment is calibrated, validated, and properly maintained at all times.
- Batch & Document Control: Execute batch record reviews to ensure timely release schedules. Support the document control system and record retention processes.
- SOP Management: Develop, implement, and maintain Standard Operating Procedures (SOPs).
- Safety & Collaboration: Promote and maintain a safe, healthy, and accident-free work environment. Support broader regulatory requirements and perform other related duties as assigned.
Experience & Educational Requirements
- Education: Bachelor of Science (BSc) in a relevant scientific discipline.
- Experience: Minimum of two (2) years of experience in a cGMP facility within a Quality Control role.
- Technical Skill: Hands-on experience operating and troubleshooting HPLC (High-Performance Liquid Chromatography) in a GMP environment is strictly required.
Skills, Knowledge & Abilities
- Technical Knowledge: Strong understanding of Quality Assurance, cGMP, and GLP principles.
- Problem-Solving: Proven ability to evaluate complex quality issues, apply technical knowledge to find solutions, and participate effectively in cross-functional problem-solving teams.
- Execution & Organization: Excellent attention to detail with the ability to handle multiple tasks simultaneously and work independently under detailed instructions.
- Communication & Teamwork: Exceptional oral and written communication skills (English proficiency required). Strong interpersonal skills with a demonstrated ability to build cooperative working relationships.
- Digital Literacy: Computer literate and proficient with standard laboratory software.
