2535 External Quality Associate I
Duties:
We are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
A high-level of initiative, energy, and motivation are key role requirements, as well as organizational skills and the ability to motivate others.
The External Quality Associate 1 reports to the External Quality Manager and is responsible for supporting Quality Systems related to operations, product specification change controls and batch release processes.
This position requires interaction with multiple levels in Quality, Regulatory Affairs, Manufacturing, Supply Chain, Materials Management, and Contract Manufacturing Operations.
The Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
These individuals build and maintain the Company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Skills:
Create and/or revise product specification documents, following MAA, BLA, CTA, IND and/or IMPD filings, in the Company’s controlled document management system (Veeva).
Initiate and set-up change control workflows for product specification revisions in Veeva and the Company’s quality management system (TrackWise).
Coordinate TrackWise and Veeva change control workflows for review and approval of product specification revisions.
Monitor and ensure document implementation timelines.
Monitor backlog in associated trackers.
Generate custom Certificates of Analysis to support lot release, new market applications, annual product reviews, and/or market renewals.
Ensure all individual training and group-specific guidelines are kept current.
Provide assistance with training new staff.
EXPERIENCE
Minimum 3-5 years of experience in a Quality, Compliance, and/or Regulatory setting.
Strong attention to detail, organization and communication skills.
Ability to maintain organization of a large volume of data in a systematic manner.
Proficiency with computer systems (Microsoft Office Suite).
Proficiency with eQMS (TrackWise), LIMS, Oracle EBS, eCDMS (Veeva) and Office365 preferred.
Education:
Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical engineering, chemical or biological sciences) is required.
Advanced degree preferred.