Title: QA Associate II
Location: Bothell, WA
Start date: ASAP
Pay Rate Range: $30-35

The successful candidate will perform review of documents, records and procedures supporting disposition of clinical or commercial cGMP products and participate in cGMP operations, as assigned.
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Contributes to the completion of specific programs and projects.
Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Uses ability as a skilled specialist in accordance with company policies and procedures to complete complex tasks in creative and effective ways.
Normally receives no instruction on day-to-day work, general instructions on new assignments.
Individual contributor with no people management responsibilities.

Principal Responsibilities:
Perform QA role to support cGMP production and testing operations
Provide QA in plant support to support manufacturing operations
Review executed batch production records to ensure compliance with approved procedures and cGMP expectations. Communicate and resolve discrepancies
Compile or assist with managing lot files
Review/Approve Direct Material (i.e., raw material, other) testing to ensure data accuracy, conformance to specifications and documentation standards
Lead/Assist labeling efforts of materials (i.e., raw materials, other) for production
Work with internal cross functional teams to resolve issues and identify corrective actions
Review and Approve deviations, CAPA, and change controls. Monitor responsible open quality system records to closure
Review cGMP Controlled Documents such as master batch production records, test methods, specifications and manage implementation of required changes to meet cGMP and internal standards
Write and review Standard Operating Procedures as needed
Assist with the reporting and/or presentation of department metrics
Participate in audits: internal, external (vendor, partner), and regulatory inspections
Other duties as requested.

Qualifications:
Bachelor s degree in a scientific discipline or equivalent with 2 years or more relevant industry experience in a cGMP/FDA regulated environment such as Manufacturing, QC or QA
Knowledge of cGMP and applicable FDA/international regulations
Direct experience with plant operations, pharmaceutical/biotechnology manufacturing and analytical testing a plus
Experience working with clinical and/or commercial products
Detail oriented team player with effective planning, organization, and execution skills
Excellent communication skills with internal and external personnel essential
Ability to work effectively at a fast pace with cross functional departments
Innovative, proactive, and resourceful: committed to continuous improvement
Ability to anticipate and mitigate challenges
Experience with quality management systems (QMS), electronic documentation management systems (EDMS) and inventory management systems
Strong computer skills (i.e., Word, Excel)
Ability to work occasional weekends, holidays or overtime, as needed
Ability to lift up to 25 Pounds and gown into manufacturing plant
Ability to travel domestically and/or internationally up to 10% of time

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.