- Bachelor's Degree
- Master's Degree
- Communication Skills
- Root Cause Analysis
- Quality Systems
- Dental Insurance
- Health Insurance
- 401(k) Matching
- Vision Insurance
- Disability Insurance
Our client is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of their dedication to building and empowering their internal teams, our client is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, they deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. They forge exceptionally strong partnerships with their clients, and they never lose sight of their pledge to deliver a reliable and compliant drug substance supply, Right, On time. They are seeking a Quality Assurance Associate to join their team in Bothell, WA.
The QA Associate IV (Systems Specialist IV) is responsible for ensuring compliance with applicable regulatory guidelines and requirements. This role requires attention to detail, organization, multi-tasking, and ability to interact with people who might be junior or senior to the incumbent.
Support with Regulatory Inspection Readiness.
Maintain inspection readiness through inspection preparedness program and periodic readiness verification.
Execute against plan (training, document readiness, response preparation and readiness).
Maintaining the Quality Systems in compliance with cGMP, FDA and ICH applicable regulations.
Provide support to other functional areas for dealing with Deviations, CAPA, Change Control, Complaints and Recalls.
Create and update SOPs, company Policies and other GMP documents.
Management of the internal audit program.
Creation and management of the execution of the internal audit schedule.
Train internal auditors.
Support the program to pro-active management of clients to ensure confidence in Quality systems including:
Establish Quality Agreements with clients consistent with Global standard.
Ensure communications with client are maintained consistent with Quality Agreement and positive client experience.
Support required client audits and provide observation responses consistent with timeline commitments.
Compliance Documentation and Licensing.
Establish a calendar to provide visibility to compliance documentation requirements.
Generate and provide required documentation to clients and Regulatory authorities.
Other duties, as assigned.
BA/BS in Biology, Chemistry or similar Science education. MS degree preferred.
8+ years QA or related experience working in a regulatory environment or position (GLP, GCP or GMP) with a minimum of 5 years of experience in Quality Systems within Biopharmaceutical industry.
Prior supplier auditing experience required.
Strong understanding of cGMP’s and concepts in several quality systems.
Demonstrated ability to work on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Demonstrated knowledge of GMP, GCP and both US and foreign regulations (EU, IPAC, ICH) is required.
Strong oral and written communication skills.
Ability to negotiate needed actions and manage difficult interactions effectively.
Knowledge of computerized support tools and software for audit tracking and reporting.
Demonstrated knowledge of root cause/trend analysis/risk analysis.
Demonstrated thorough knowledge of quality processes and compliance.
Demonstrated ability to act as a functional expert.
Demonstrated ability to multi-task and work on several QA projects and problems.
Ability to work under only general direction.
Ability to independently determine and develop approach to solutions.
Benefits are available to eligible VanderHouwen contractors and include coverage for medical, dental, vision, life insurance, short and long term disability, and matching 401k.
VanderHouwen is an award-winning, Women-Owned, WBENC certified professional staffing firm. Founded in 1987, VanderHouwen has been successfully placing experienced professionals throughout the Pacific Northwest and nationwide. Our recruitment teams are highly specialized in either Technology and IT, Engineering, or Accounting and Finance career markets. Our recruiters value building meaningful, professional relationships with each candidate as well as developing honed knowledge of companies' staffing needs and workplaces. Partner with us to land your next exciting career.
VanderHouwen is an Equal Opportunity Employer and participates in E-Verify. VanderHouwen does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by applicable local, state or federal civil rights laws.”