Raw Materials Quality Senior Specialist - Site Based, Redmond & Seattle, WA

Evotec•Redmond, WA

8d•Onsite

About The Position

We are seeking a GMP focused Raw Material Quality Senior Specialist to support QC operations for late stage and commercial biologics manufacturing. In this role, you will be a key contributor to ensuring the quality, consistency, and regulatory compliance of raw materials across our Seattle and Redmond GMP facilities. You will play a critical role in new raw material onboarding, impact assessment and process change implementation in response to supplier, material, compendial, and guideline changes —all essential to our path toward commercialization. This is a role for someone who is both scientifically sharp and operationally disciplined, who can think creatively while executing flawlessly in a regulated environment. The Raw Material Quality Senior Specialist will provide implement user requirements, risk assessments, and raw material specification documents through coordination across internal functions and suppliers in support of our GMP manufacturing operations at the Seattle and Redmond, WA GMP facilities. These efforts support GMP manufacturing activities for biotherapeutic products.

Requirements

BS in Chemistry or related field with 5+ years relevant Quality experience in GMP biopharmaceutical or biotechnology industry.
Materials science background and understanding of chemical compatibility and extractables/leachables requirements.
Strong understanding of cGMP, FDA, and EMA regulations for raw materials and relevant ICH, ISO, and USP/EU/JP compendial guidance.
Experience supporting regulatory compliance inspections and responses.
Understanding of process equipment and operations needs to manufacture biotherapeutics and supporting analytics to qualify and release raw materials.
Comprehensive understanding of biologics regulatory requirements, risk management principles, investigation process, and science-based decision making.
Ability to interpret, assess, and effectively communicate impact of raw materials and associated results on process data.
Strong focus on quality and attention to detail as well as effective time management and organizational skills.
Key competencies in verbal and written communication, data analysis, judgement and decision making, and building teams.
Strong computer skills including Microsoft Office Suite (Excel, Word, PowerPoint) and eQMS databases.
Ability to adapt, work in a fast-paced environment, and concurrently manage multiple projects and priorities.
Must demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team.

Responsibilities

Apply knowledge and experience to drive supplier and material onboarding activities and change management in accordance with approved procedures, industry standard and current regulatory requirements.
Investigate internal GMP supplier quality events (e.g., deviations, CAPAs) with escalation of critical issues with potential to affect patient safety, product quality, or supply.
Assess supplier change notifications and initiate/process any follow-up actions necessary to determine impact and ensure compliance.
Support supplier onboarding audits, qualification, and routine performance monitoring audits.
Create, update and obsolete material specifications and procedures as needed.
Initiate and assess change controls for impact to supplier quality management, process impact, and patient safety.
Lead in raw material risk assessments, including assessment of extractables/leachables.
Collaborate Supplier Quality Management, Quality Control, Manufacturing Operations, Technical Operations, Materials Management, F&E, Process Development and EH&S functions to ensure thorough assessment of raw materials and associated investigations in support of product quality and patient safety.
Support audit and inspection readiness, including support and preparation of responses to observations and ensuring response CAPAs are effective.
Drive planning, coordination, and continuous improvement of processes and systems to assure the quality of released raw materials.
Provide communication as to the status of deliverables to customers, management, and stakeholders.
Participate in daily and weekly operational meetings to support raw material supply and issue resolution.