Associate Quality Specialist

Locus Biosciences is seeking a full-time Associate Quality Specialist. This individual will directly report to the Associate Director of Quality and will be responsible for leading, supporting and ensuring continued suitability of the Quality Management System (QMS) with a primary focus on design control, validation, risk management, supplier management, process control, post-market surveillance, complaint handling, CAPA, auditing, change control, document control and training.

Responsibilities will include:

• Ensure that the Quality System is compliant with domestic and international quality system regulations.

• Promote awareness of the Quality System and provide training to individuals across the organization on quality management principles, tools, techniques and best practices.

• Support the implementation of corporate policies and procedures relating to quality, design control, risk management, project management, process development, supplier management and FDA/ISO compliance.

• Engineer solutions to address product and process quality issues. Work as part of a team to drive forward continual improvement initiatives and address compliance challenges.

• Initiate and coordinate the inspection and testing of raw materials, work-in-process, finished goods and environmental conditions.

• Design and develop forms, instructions and sampling procedures for recording, evaluating, and reporting quality and reliability data.

• Write, Coordinate and support the Corrective / Preventive Action (CAPA), Deviation, and Change Control systems.

• Support the document control and training system.

• Support the investigation, reporting, and resolution of customer complaints.

• Conduct supplier audits and partner with suppliers to address Requests for Supplier Corrective Action Report (SCAR).

• Coordinate and support the annual audit program; manage, schedule, perform and report on internal, external and supplier audit activity. Compile and report quality metrics. Assess and report post-market surveillance data in accordance with regulatory requirements.

Candidate must possess:

• Bachelor’s Degree in Biology, Chemistry, Life Sciences or Engineering with one year of experience in a quality role supporting clinical research, pharmaceutical development or IVD development; OR

• Associate’s Degree in Biology, Chemistry, Life Sciences or Engineering with three years of experience in a quality role supporting clinical research, pharmaceutical development or IVD development

• Note: An advanced degree in Biology, Chemistry or Life Sciences accepted in lieu of professional experience.

• Thorough understanding of quality philosophies, principles, systems, methods, tools and standards

• Excellent communication skills

• Excellent writing skills

• Strong organizational skills Associate Quality Specialist

• Ability to handle multiple projects simultaneously

• Exhibits self-reliance in managing personal workload and schedule of deliverables

About Locus Biosciences

Locus Biosciences is a clinical-stage biotechnology company developing CRISPR-enhanced precision antibacterial products (crPhage™) to address critical unmet medical needs in bacterial infections and microbiome indications in oncology, immunology and neurology therapeutic areas. The Locus platform combines CRISPR-Cas3, which permanently degrades target DNA within a bacterial cell, with bacterial viruses called bacteriophage to specifically kill target pathogens while leaving non-target bacteria (i.e., the rest of the patient’s microbiome) unharmed. Locus completed its first human clinical trial in early 2021, with a crPhage product targeting Escherichia coli bacteria in the urinary tract. Locus also recently announced strategic collaborations with Johnson & Johnson, BARDA, and CARB-X to develop crPhage products targeting respiratory infections, E. coli urinary tract infections, and Klebsiella pneumoniae infections, respectively. For more information about Locus visit https://www.locus-bio.com/