QC Manager/Senior Manager of Sample Management, Stability, and Critical Reagents Group

Location
Redmond, WA
Posted
Jun 11, 2022
Ref
REQ-04932
Discipline
Quality, Quality Control
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time

Just is seeking a motivated and creative QC Senior Manager or Manager of Sample Management, who desires a significant opportunity to improve worldwide access to biotherapeutics, to lead a fast-paced, collaborative, and multidisciplinary team within our QC organization. The successful candidate will have leadership, sample management, critical reagents, and experience overseeing stability programs in a regulated laboratory as well as exceptional attention to detail. The ideal candidate is highly organized and works well both independently and in teams.

Responsibilities:

  • Oversee the daily activities of the group
  • Develop compliant policies and procedures for chain of custody/sample management
  • Develop a robust critical reagents program
  • Create stability protocols, manage stability studies for DS and DP, provide results to clients, and author stability summary reports
  • Play a key role in deployment of a LIMS system
  • Coordinate external testing for cell banks and unprocessed bulk samples
  • Provide hands on training to staff on efficient and compliant sample handling and management
  • Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing, and team milestones are achieved
  • Author SOPs as well as guidance and policy documents
  • Identify gaps, design collaborative solutions, and implement improvements
  • Oversee QC laboratory investigations, deviations, OOS, and CAPAs as it pertains to sample management, stability, and critical reagents

Requirements:

  • 8 to 10+ years of cGMP experience and a BS in Biology, Biochemistry or related field
  • Demonstrated leadership abilities
  • Experience with late stage or commercial biologics products
  • Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA)
  • Extensive knowledge of GDPs and cGMPs as they relate to chain of custody, critical reagents, and sample management
  • Experience with the operation, deployment, and administration of laboratory information management systems (LIMS).
  • Excellent communication and organizational skills
  • Experience with Microsoft Office (Word, Excel, PowerPoint)
  • Experience with ERP or relational databases


Middle Management