Main responsibilities will be to work in coordination with Allston Mfg, QA, MSAT, QC, QS and QRM to review documents, search in TW, follow-up with SMEs, system owners and reconcile the legacy QRM log, work with Doc Control to archive QRM documents as needed. Provide project management support for risk review schedule and other activities as applicable.
Project management role, supports development and coordinates execution of risk review schedule for the site. Record retention, archiving tasks, confirm that legacy risk assessment took place. Locate the report. Link to any quality system related to the assessment. As applicable, define list of open mitigations as applicable and status.
The QA Specialist Temp. will be in a supporting role for the Quality Risk Management Program at the Allston Landing Facility. This position will report to the AD QRM, Quality Compliance. He/she will work closely with the site subject matter experts, Quality Risk Management ensuring that the status of QRM legacy documents are defined and reconciled while following FDA, EU and other global GMP guidance and regulations
Skills:- Project management, operational excellence (Opex) experience
- Document controls, record retention tasks using Livelink
- Trackwise Access
- Access to Allston Risk Livelink and Sharepoint (can be granted)
- Good advanced Trackwise query experience
- Site knowledge of departments, systems, individuals
- Ability and time to follow up with people and track down information quickly
Education:Bachelor's Degree with 2 years of pharmaceutical/biotechnology industry experience.
Ability to collaborate cross-functionally
Demonstrated exemplary oral and written communication skills
Detail orientated and ability to follow standard operating procedures is essential
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Last updated on Mar 29, 2016