Southport, NC
Full-time

Full Job Description

Cygnus Technologies, a Maravai LifeSciences company, is seeking a Quality Assurance Associate to join our growing team. This role is responsible for supporting Quality Operations function, including the review and release of batch records for products, control of documentation, initiate deviations, NCMRs, CAPAs, OOSs and complaints. This role ensures compliance with company policies and procedures and applicable domestic and international standards and regulations.

Responsibilities

Responsible for reviewing and approving batch records.
Responsible for initiating and collaborating on Quality Events (e.g. Deviations, NCMRs, CAPA and OOSs) to ensure appropriate investigations are completed in a timely manner.
Conduct quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness. Use of quality tools, such as 5-Why's, FMEA's, Cause and Effect Diagrams, Process Mapping, etc.
Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations.
Work with various functions, including Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT, etc. to continuously improve the Quality Management System.
Perform other duties, as assigned

Qualifications

Minimum, Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.).
Quality professional with a minimum of 0-5 years relevant experience in a life science industry.
Knowledge of ISO 9001 standards (or ISO 13485) and of cGMPs regulations (e.g. 21 CFR 210, 211 or 21 CFR 820)
Strong and effective verbal and written communication skills.
Strong interpersonal, teamwork and customer interfacing skills.
Strong problem-solving skills and analytical skills applied to investigations.
Self-motivated and able to organize and prioritize multiple tasks.
Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization.