Quality Control Analyst II

About this role:

The Quality Control Analyst II will perform testing for molecular diagnostics product programs through lot release assays. This position will take on complex laboratory and documentation tasks, including the creation of in-depth reports and execution of highly involved testing protocols. The QC Analyst II performs all activities according to approved written procedures. In addition, QC Analyst II may be assigned the responsibility of compliance functions within the laboratory, such as released product quality monitoring, equipment IQ, OQ, PQ and calibration activities, reference standard inventory control, cleaning and method validation and transfer activities. The QC Analyst II may be required to write or revise SOPs, analytical procedures, analysis reports, validation documents, etc.

What we offer:

• Join the fast-growing team with all the opportunities to build together
• Amazing team to work with
• Seegene pays 100% of Health insurance/Life/STD/LTD premium for the employee and 70% for dependents. Other voluntary insurance is also available.
• Generous 401k, no vesting period, no waiting period
• Generous vacation and corporate holidays
• Various employee discounts and perks

Job Responsibilities:

• Implement new analytical methods for molecular assay products
• Author, review and approve laboratory procedures, including equipment use and maintenance, analytical method verification/qualification/transfer and/or validation protocols and reports
• Execute analytical methods associated to method verification, qualification, transfers and/or validations, including use of bio-specimens
• Analyze data, review, report and communicate results
• Ensures availability of materials and equipment required to implement analytical methods in QC
• Support instrument qualification and associated change controls
• Assess analytical method performance and investigate assay trends
• Participate in laboratory investigations including unexpected results or out of specification root cause analysis and implement solutions
• Identifies and implements corrective/preventive actions (CAPA)
• Recommend, review and assess proposed changes to analytical methods and QC equipment through CAPA and Change Control as required
• Support phase-appropriate QC capabilities, business processes, and procedures
• Maintain current knowledge of regulations and policies to ensure that the QC function remains in compliance with applicable company requirements and global regulations
• Partner with Research & Development and Quality Assurance to deliver analytical strategy for products
• Work closely with Research &Development and Quality Assurance to transfer/verify/qualify/validate analytical methods in the Quality Control Laboratories

Minimum/Required Qualifications

• Bachelor’s degree in a scientific field (biochemistry, molecular biology, etc.)
• 1+ years’ experience in quality control
• Ability to travel up to 10% of the time domestic and international

Additional/Preferred Qualifications

• Understanding of FDA Design Controls and Risk Management
• Assay as a medical device product experience
• Strong GMP laboratory skills
• Molecular assay experience

Desirable Characteristics/Attributes

• Ability to work in a fast-paced and dynamic environment that will require management of multiple competing priorities
• Ability to work independently, able to take ownership of a given assignment
• Leadership, collaboration, and organizational skills
• Excellent technical writing, communication skills, and project management skills
• General laboratory investigation, OOS, and root cause analysis experience is required.
• Team player and good interpersonal skills
• Working knowledge of document management and lifecycle
• Knowledge of product testing, data analysis, and reporting
• Advanced knowledge of product testing, data analysis, and reporting
• Advanced laboratory skills (e.g., run tests on molecular diagnostics system as well as basic skills for pipetting, weighing, aliquoting, etc.)
• Working knowledge of regulations and inspection/audit readiness
• Advanced knowledge of QMS (CAPA deviation change control, laboratory investigation)
• Knowledge of executing methods for qualification, transfers and validation, preferred
• Self-motivated
• Detailed oriented

You can apply for this position via LinkedIn using the button below or by completing the application form at the bottom of this page.