Quality Control Analyst II

BioPharma Consulting JAD Group is seeking a Quality Control Analyst II to join our dynamic team MA. The Quality Control Analyst II will be responsible for conducting various analytical tests, maintaining laboratory equipment, and assisting in method development and validation activities, while adhering to Good Manufacturing Practices (GMP).

Key Responsibilities :

• Perform routine and non-routine analytical and / or microbiological assays, with increasing complexity, to support raw materials, in-process samples, product release, and stability studies, following established SOPs
• 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 is submitted timely; may qualify as a data reviewer to ensure timely and efficient data availability.
• Perform role-specific operational assignments (e.g., raw material sampling and testing, environmental monitoring, product 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 ALNY 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.
• Collaborate with QC and cross-functional teams to ensure seamless quality control operations and to support the collective Alnylam goals
• Pursue ongoing training and development to deepen expertise in QC testing techniques and regulatory compliance.
• May assist in data verification for regulatory submissions.
• Participate in inspection readiness activities as well as supporting onsite audits and inspections, as needed.
• Support continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.
• Collaborate with other organizational functions including Manufacturing, Materials Management, and Quality Assurance to ensure alignment with overall business goals.

Skills :

• Pharmaceutical / Biotech industry experience with 2 years in a regulated laboratory setting, Quality Control, or equivalent, relevant experience
• Data analysis experience preferred
• Ability to work under direction, with attention to detail, in an environment where priorities shift
• Good communication and teamwork abilities, capable of working effectively in a collaborative environment
• Knowledge of LIMS, Excel, Word, and PowerPoint is helpful

Requirements

Education :

• B.S. in chemistry, biology, or biochemistry, or related scientific field, with at least 2 years of experience; OR
• Associates Degree, Biotech Certificate, or equivalent considered, with at least 4 years of experience.

Qualifications :

• Strong analytical skills and familiarity with laboratory instruments.
• Excellent written and oral communication skills in both English and Spanish.
• Detail-oriented with a commitment to quality and compliance.
• Experience in a cGMP environment is preferred.
6 days ago