Quality Control Analyst - Biotechnology

Job Overview

We are seeking a meticulous Quality Analyst to join our team. The ideal candidate will be responsible for ensuring the quality of our products meets industry standards and customer expectations.

Responsibilities

• Perform routine and non-routine analytical and/or microbiological assays to support raw materials, in-process samples, product release, and stability studies, following established SOPs
• Support a continuous operational schedule by supporting weekend laboratory operations (Analytical, Microbiology, Raw Materials).
• Maintain up-to-date training records, adhere to the testing schedule, and ensure the timely completion of all assignments to support the seamless operation of QC activities and uphold the department's commitment to meeting project timelines and quality metrics
• Assist in the maintenance of laboratory equipment and inventory, including the preparation of reagents and samples to ensure smooth laboratory operations
• Ensure data are reviewed timely; qualify as a data reviewer to ensure timely and efficient data availability.
• Perform role-specific operational assignments (e.g., raw material processes including SAP transactions, environmental monitoring, in-process testing, etc.).
• Contribute to the revision and updating of controlled documents, including SOPs, work instructions, and test methods, to ensure continuous improvement and compliance with current industry standards and regulatory requirements
• Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance.
• Actively participate in continuous improvement efforts by identifying and suggesting enhancements to methods and laboratory processes, particularly those related to efficiency and reliability.

Qualifications

• B.S. in chemistry, biology, or biochemistry, or related scientific field.
• Pharmaceutical/Biotech industry experience with 4 years in a GMP Quality Control function or equivalent, relevant industry experience
• Experience in method transfer and/or analytical method implementation; solid understanding of method lifecycle management and phase-appropriate approach is desirable
• Demonstrated technical writing skills, with preference for technical writing of investigations
• Proficient in data analysis and interpretation, with excellent attention to detail to inform decision-making
• Solid problem-solving skills and experience in conducting investigations and implementing CAPA

If you are passionate about maintaining high-quality standards and driving continuous improvement, we encourage you to apply for the Quality Analyst position.

Job Types: Full-time, Contract

Pay: From $40.00 per hour

Schedule:

• 10 hour shift
• Day shift
• Monday to Friday
• Night shift
• Weekends as needed

Application Question(s):

• Are you willing to work weekend?

Education:

• Bachelor's (Preferred)

Experience:

• Quality assurance: 4 years (Preferred)
• Microbiology: 4 years (Preferred)
• GMP: 4 years (Preferred)
• Manufacturing: 4 years (Preferred)

Work Location: In person

Salary : $40