Medical Quality Auditor

Job Description:

We are seeking a Quality Control Analyst III to join our team in Norton, MA.

This is a 08 months contract position with the potential for extension. The role requires flexibility for weekend coverage and will involve working primarily on-site at our facility in Norton, MA, with occasional responsibilities at other client locations.

The Quality Control Operations (QCO) Analyst III Contractor will play a crucial role in supporting the department's efforts to maintain the highest standards of quality and compliance from development through to commercialization.

Key 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.
• 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.
• 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.

Requirements:

• 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;
• Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously;
• Excellent communication and teamwork abilities, capable of working effectively in a collaborative environment;
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.