Quality Control Analyst II Sample Management

Description

Position at Seagen

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines.

As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells.

Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission.

By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world.

Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary :

This position supports daily sample management operations to ensure samples are available for Quality Control to test (received from or sent to the correct internal and external locations) and ensurecomplete chain of custody ismaintainedin accordance with standard operating procedures (SOPs) in a cGMP compliant QC laboratory.

This position is dedicated to one QC site but mayprovide backup to other QC sites.

Principal Responsibilities :

Perform routine sample management activities, including sterile sample aliquotting and proper storage and disposal of samples

Perform sample receipt and prepare outgoing shipments

Coordinate with external contract testing laboratories for sample submission and testing

Complete and review chain of custody documentation, temperature data, and LIMS entries

Archive chain of custody documents and other QC documentation as needed

Perform routine maintenance on sample management laboratory equipment, such as cleaningBSCs, refrigerators, and freezers

May create advanced testing templates in LIMS

May be subject matter expert for sample management in audits and regulatory agencyinspections

Assist the LIMS team in system troubleshooting and process improvements

Perform periodic inventory of product samples and product reference materials

Maintain close communication and interaction with QC lab leads and manufacturing staff to ensure on-time distribution of samples

May set up elements in systems integrated with LIMS to auto-report stability data (.,Discoverant)

Evening, weekend, and / or on-call work may be required

May assist in equipment management including but not limited to reviewing equipment logbooks, reviewing tasks in maintenance management system, and coordinating with Facilities forscheduling maintenance and repairs

Apply the principles of good manufacturing practices (GMP) on a daily basis

Create and revise standard operating procedures (SOP’s), work instructions, and otherdocuments as needed

Identify, participate in, and / or lead continuous improvement projects

Author and own deviations, CAPAs, and change controls as needed

Train other personnel

Maintain training to current standards and procedures on all assigned curriculums

Fully comply with company health and safety procedures and practices.

Expected Qualifications :

2+ years relevant experience

Bachelor’s degree or associates degree and 2+ years in relevant field

Be highly organized with an attention to detail

Ability to keep order of multiple projects / tasks

Preferred Qualifications :

Experience authoring and / or revising Standard Operating Procedures

GMP experience

Experience with a LIMS or other sample / inventory management system

The hiring pay range for this position is $70,000 - $90,000 per year based on skills, education and experience relevant to the role.

Other components of total compensation include a competitive equity grant at the time of hire and an annual bonus.