We are seeking a Quality Control Scientist to join our team. This role is responsible for ensuring compliance with Good Manufacturing Practices (GMP) and supporting quality control activities, including method transfers and analytical method implementation. The ideal candidate will have a strong scientific background, technical writing expertise, and analytical problem-solving skills to contribute to investigations and Corrective and Preventive Actions (CAPA).
Key Responsibilities:
- Perform quality control testing in accordance with GMP regulations.
- Support method transfer and analytical method implementation.
- Conduct data analysis and interpretation to ensure accuracy and compliance.
- Develop and review technical documentation, including investigations.
- Identify and implement CAPAs to address quality concerns.
- Collaborate with cross-functional teams to ensure effective problem-solving and compliance.
- Maintain accurate records and ensure proficiency in LabWare LIMS and other relevant software.
- Qualifications:
- Bachelor’s degree in Chemistry, Biology, Biochemistry, or a related scientific field.
- Minimum of 4 years of experience in a GMP Quality Control function or equivalent industry experience in pharmaceutical/biotech.
- Strong understanding of method lifecycle management and phase-appropriate approaches.
- Excellent technical writing skills, particularly in documenting investigations.
- Proficiency in data analysis and interpretation, with strong attention to detail.
- Solid problem-solving skills, experience in conducting investigations, and implementing CAPAs.
- Strong organizational skills and ability to manage multiple tasks autonomously.
- Exceptional communication and teamwork skills, with ability to work effectively in a collaborative environment.
- Preferred proficiency in LabWare LIMS, Excel, Word, and PowerPoint.
- Contract
- Schedule:
- Friday – Monday, 8:00 AM – 6:00 PM (4x10 schedule).
