The Quality Assurance Associate II will report directly to the QA Lead or Director.
This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for the Quality review and product release of manufacturing production records, including verification of raw materials used, verification of calculations and critical process steps, and evaluation of Quality Control testing.
Must have thorough understanding and working knowledge with Quality Control principles and concepts such as (i.e.: Bioburden/ Endotoxin Testing, RODI testing, pH, Conductivity etc.).
Thorough knowledge of ELISA assay qualification and testing.
Must have thorough understanding of Good Documentation Practices (GDP), identification and review and approval of deviation investigations and Out of Specifications (OOS) results, able to perform root cause analysis and generate corrective actions to improve processes/systems.
· Perform batch record review; to include review of production records, quality control records such as (i.e.:
monthly RO/DI, weekly Environmental Monitoring records), and weekly/monthly logs.
· Thorough knowledge of ELISA principles in reading test results.
· Subject Matter Expert for Repligen Quality Management Systems and product line.
· Oversees Quality System processes including complaints, non-conformances and deviations.
· Manages daily schedule and communicates with peers for completion of tasks associated with product release.
· Generation, review and approval of quality investigations.
· Ability to lead quality meetings with multi-functional departments/individuals.
· Identification and escalation of Out-of-Specifications (OOS) results.
· Label Verification.
· Ability to identify product.
· Ability to identify, detect and escalate quality related trends.
· Mentor and develop Quality Associate I personnel.
· Attend daily Tier II meetings.
· Assist with the maintenance of the Repligen Quality Management Systems, as assigned.
· Bachelor’s degree in Biological Science or other science related discipline.
· Minimum 2-5 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.
· Lead/Internal auditor certification preferred.
· Experience and knowledge of IT software platforms that support Quality Management Systems.
· Understanding of Good Documentation Practices preferred.