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Company

Original Job Post

AGC Biologics · 6 days ago

Quality Assurance Associate, Senior

Bothell, WA

Full-time

Onsite

Senior Level

$84K/yr - $115K/yr

7+ years exp

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BiotechnologyIndustrial

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Responsibilities

Support Regulatory inspections

Perform and/or lead inspection readiness activities

Maintain inspection readiness through inspection preparedness program and periodic readiness verification

Execute against plan (training, document readiness, response preparation and readiness)

Author, Review, and Approve SOPs, company Policies, and other GMP documents

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

Maintain compliance documentation and licensing

Establish a calendar to provide visibility to compliance documentation requirements

Generate and provide required documentation to clients and Regulatory authorities

Participate and lead Improvement initiatives aimed to add efficiency to the Quality processes.

Develops and leads large and/or multiple programs, initiatives, and activities for the function or broad organization with moderate resource requirements, risk, and/or complexity.

Analyzes and evaluates issues and makes decisions within general parameters under little supervision.

Contributes to development of best practices for functional area.

Communicates moderately complex concepts and interacts with others to inform and direct action.

Acts as a resource for less experienced team members and colleagues.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

CGMPQuality systemsGMPGCPComputerized toolsAudit trackingQuality processesComplianceProject managementIndependent problem-solvingCommunicationNegotiationProblem-solvingMulti-taskingLeadershipTeamworkPersuasion

Required

BS/BA degree and 7+ years of relevant experience.

Strong understanding of cGMP’s and concepts in several quality systems.

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 quality processes and compliance.

Demonstrated ability to multi-task and work on several projects and problems

Ability to work under only general direction

Ability to independently determine and develop approach to solutions

Analyzes multiple sources of information and evaluates several alternative solutions before confirming correct path.

Explains complicated information and effectively lays out variations of alternatives to consider.

Works across teams effectively.

Applies understanding of how the team relates to other closely related areas to improve efficiency of own team.

Leads others to solve complex problems; uses sophisticated analytical thought to exercise judgment and identify appropriate solutions.

Explains difficult or sensitive information and works to build consensus and is building a skill set to persuade others.

Company

AGC Biologics

Glassdoor

2.8

AGC Biologics is a global Contract Development and Manufacturing Organization with a commitment to deliver the highest standard of service.

Founded in 2001

Bothell, Washington, USA

1,001-5,000 employees

http://www.agcbio.com/

H1B Sponsorship

AGC Biologics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (1)

2022 (7)

2021 (5)

2020 (3)