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 :
The QA Specialist is responsible for Quality oversight of facilities, utilities, and warehousing operations at the North Creek manufacturing facility.
In conjunction with the area management, the position is responsible for ensuring that activities remain in compliance with FDA and ICH guidelines, global regulatory expectations and international cGMPs.
The Specialist will serve as a quality point of contact and quality subject matter expert for Real Estate and Facilities, Manufacturing, and Materials Management to ensure cGMP compliant operations at the site.
Works under consultative direction toward predetermined goals and objectives and contributes to those goals and objectives.
Assignments are largely establishedin accordance with schedules and deliverables and are often self-initiated.Principal Responsibilities :
Review / Approve Deviations, CAPAs, and Change Controls related to facility, utilities, automation, and warehouse (WHSE).
Monitor open quality system records to closure
Review / Approve Facilities, Utilities, Automation, Warehouse records to ensure compliance with approved directives / specification, site procedures and cGMP expectations
Review / Approve quality system documents such as SOPs, Work Orders, others as needed
Provide Quality oversight of facility related programs including calibration and maintenance, facility / utility monitoring, pest control
Provide select Quality oversight of WHSE activities (shipping, receiving, materials storage and issuance)
Provide MQA (Manufacturing Quality Assurance) support as needed (area walk-throughs, other as assigned)
Provide close cross communication and collaboration with Customers and site MQA on site activities (., warehouse activities, pest control and facility maintenance shutdown)
Assist with reporting and / or presentation of department metrics
Participate in audits : internal, external (vendor, partner), and regulatory inspections
Other duties as requested
Required Qualifications :
Bachelor’s degree in a scientific discipline or equivalent with 8 years or more relevant industry experience in a cGMP regulated environment such as Quality Assurance, Facilities, Manufacturing
Knowledge of cGMP and applicable FDA / international regulations
Experience with clinical and commercial operations, pharmaceutical / biotechnology manufacturing, maintenance / calibration, and automation systems knowledge a plus
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 site / functional departments
Innovative, proactive, and resourceful : committed to continuous improvement
Experience with quality management systems (QMS), electronic documentation management systems (EDMS), ERP and maintenance systems (., MAXIMO or other)
Experience supporting audits and regulatory inspections
Ability to lift up to 25 pounds
Preferred Qualifications :
Knowledge and experience with US / EU GMPs, ICH and other applicable international regulations
Experience with the production facilities, utilities, and automation of pharmaceutical industry (biologic)
Experience working with calibration and maintenance preferred
Excellent communication skills and proven ability to work well with internal and external teams
Experience with electronic documentation management systems preferred
Ability to prioritize work and handle multiple assignments, while maintaininga high level of quality
The hiring pay range for this position is $98,000 - $127,000 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.
Quality Assurance Specialist (Facilities/WHSE)
The Specialist will serve as a quality point of contact and quality subject matter expert for Real Estate and Facilities, Manufacturing, and Materials Management to ensure cGMP compliant operations at the site. The QA Specialist is responsible for Quality oversight of facilities, utilities, and ware...
Quality Assurance Shop Floor Specialist, Night Shift
The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump). Conduct Quality on the Floor activities including quality walk-throughs of the production, testing and warehouse locations. This role directly supports Jum...
Quality Assurance Document Control (QADC) Associate Specialist
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and ...
Quality Assurance Shop Floor Specialist, Night Shift
Conduct Quality on the Floor activities including quality walk-throughs of the production, testing and warehouse locations. GMP quality operations for the Bothell Manufacturing Plant (Jump). This role directly supports Jump’s release for infusion (RFI) timeline from the date of manufacture and will ...
Quality Assurance Specialist
As a Quality Assurance Specialist, you'll play a vital role in upholding our commitment to quality and making a positive impact on patient care. As a Quality Assurance Specialist, you'll be responsible for maintaining and enhancing our Quality Management System (QMS). Shape the Future as a Quality A...
Specialist, Quality Assurance Document Control, Label Issuance, Cell Therapy
The Quality Assurance Document Control (QADC) Labeling Specialist supports the cGMP Document Control operations for the BMS Jump site, including the coordination, issuance, reconciliation, and management of production labels and records. This may require the use of relational databases and reporting...
Quality Assurance Specialist
As a Quality Assurance Specialist,. A minimum of 3 years of experience in pharmaceutical Quality Assurance, with direct experience in Quality Management Systems. Quality Management System performance metric preparation and reporting. Compile, contextualize, evaluate, and present Quality Systems data...
Quality Assurance Specialist - IT
Follow established procedures for executing test scripts against firm applications.Make suggestions for improving QA procedures, scripts, and processes.Develop and write test plans and scripts for tracking defects and fixes in product development, software application development, information system...
Quality Assurance Specialist
As a Quality Assurance Specialist,. A minimum of 3 years of experience in pharmaceutical Quality Assurance, with direct experience in Quality Management Systems. Quality Management System performance metric preparation and reporting. Compile, contextualize, evaluate, and present Quality Systems data...
Quality Assurance Specialist
A minimum of 3 years of experience in pharmaceutical Quality Assurance, with direct experience in Quality Management Systems (Veeva experience preferred). Quality Management System performance metric preparation and reporting. Compile, contextualize, evaluate, and present Quality Systems data and me...