Quality Assurance Specialist / Senior Specialist

Location
98011, Bothell
Posted
Sep 27, 2018
Ref
P18-179
Required Education
Bachelors Degree
Position Type
Full time

Job Description:

Alder BioPharmaceuticals is seeking an experienced and highly motivated individual to contribute to their growing Quality Assurance department. This broad-based role provides a unique opportunity to participate in CMC lifecycle management and late stage commercialization efforts. The position has cGMP responsibilities for supporting product disposition of biologics (cell banks, drug substance, drug product and investigational product) manufactured for Alder BioPharmaceuticals at Contract Manufacturing Organizations (CMOs). This position requires an experienced candidate able to communicate effectively with internal personnel and multiple CMOs (vendor management experience preferred). This position has the potential for travel to CMOs, including domestic and international, and will be filled at a level commensurate with experience.

Specific responsibilities will include:

  • Assess product quality, safety, purity, identity, potency and strength as it relates to quality standards and regulatory requirements
  • Review Cell Bank, Drug Substance, Drug Product and Packaged Product batch documentation; prepare and track lot disposition packets
  • Identify discrepancies; work with CMO and internal cross functional team to resolve issues and identify corrective actions
  • Perform risk based evaluations in support of product evaluations
  • Participate in SME-based teams to resolve technical Quality related issues
  • Prepare and evaluate change controls, Quality investigations and CAPAs
  • Participate in campaign preparation activities, including review and approval of CMO master batch records and other applicable documentation
  • Collaborate with multiple CMOs, Technical Operations, Manufacturing, Manufacturing Logistics, Quality Control, Regulatory, and Clinical functions
  • Support audit and vendor qualification programs
  • Write SOPs and assist with Quality systems development, maintenance, and improvement
  • Support development, maintenance, and improvement of department key performance indicators
  • Perform trending of quality related metrics to ensure continuous quality improvements
  • Other duties as assigned

Qualifications:

  • BS or BA Degree in Life Science
  • 5+ years in Pharmaceutical/Biotech Quality Assurance
  • Excellent working knowledge of cGMP requirements, FDA and ICH guidelines and industry best practices for biologics and parenteral applications
  • Strong understanding of Quality Systems
  • Experience in product lot review and disposition processes
  • Direct experience with plant operations, pharmaceutical manufacturing, manufacturing control strategies and analytical testing a plus
  • Experience executing high priority process improvement initiatives
  • Experience with CMOs, the successful candidate will have excellent written and oral communication skills, a flexible attitude with respect to work assignments, and the ability to proactively handle multiple tasks simultaneously
  • Team player with the ability to work collaboratively with other functions gaining their cooperation in dealing with issues
  • Must possess confidence and be able to effectively communicate internally and with personnel at multiple CMOs (vendor management experience preferred) and interact with various levels of staff and management
  • Must have the ability to handle multiple responsibilities, tasks and projects simultaneously including shifting priorities
  • Strong computer skills, particularly with Microsoft Office Suite and Adobe Acrobat