Quality Associate I - Repligen

The Quality Assurance Associate I will report directly to the QA Manager.

This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role

is responsible for the Quality review of manufacturing production records, including verification of raw materials used, verification of calculations and critical process steps, and evaluation of Quality Control testing.

Must be familiar with Quality Control principles and concepts such as (i.e.: Bioburden/ Endotoxin Testing, RODI testing, pH, Conductivity etc.).

Must be familiar with Good Documentation Practices (GDP) and able to perform root cause analysis, assist with deviations and identification of corrective actions/ Process improvements.  

·   Perform batch record review (hard copied and electronic batch records); to include review of production records, quality control records such as (i.e.:

monthly RO/DI, weekly Environmental Monitoring records), and weekly/monthly logs.

·   Identification of process deviations.

·   Identification of Out-of-Specifications (OOS) results.

·   Label Verification.

·   Assist with the maintenance of the Repligen Quality Management Systems, as assigned.

·   Bind and file completed batch records and other administrative activities, if necessary.

·  Associate's degree in Biological Science or other science related discipline.

·  0-2 years’ experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent.

·  Ability to communicate with multiple departments and associates.

·  Shares timely information with peers on daily progress.

·  Ability to contribute to project teams.

·  Focus and attention to detail is critical.

·  Understanding of Good Documentation Practices preferred.