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30 days old

Quality Assurance Associate Uptown, Seattle

Kelly Services
Seattle, WA 98194
**Quality Assurance Associate Uptown, Seattle**


The Quality Assurance (QA) Associate is responsible for assisting with tasks associated with maintaining a quality management system, including conducting cGLP/cGMP/cGCP facility walkthroughs, auditing documentation compliance, assisting in submission of regulatory packages and documentation, and maintaining production records as well as all regulatory affairs functions.


Details


Responsibilities


+ Conduct facility and operations walkthroughs, observations, and process audits to ensure compliance with the Companys SOPs and Policies.

+ Be familiar with 21 CFR part 210 /211, ICH Q7, Q8, Q9 guidelines.

+ Maintain current knowledge of quality assurance-related and regulatory-related government and industry standards.

+ Review/approve key manufacturing, testing, equipment, utilities, facilities documentation including batch records.

+ Help with the investigation and triage of deviations, CAPAs or other Quality Events.

+ Ensure the application and compliance of quality systems within operational functions.

+ Responsible for the review and approval of operational documents, ensuring compliance?to?cGMP and company SOPs

+ Interact with the Quality Control group to resolve review observations

+ Assist the QA team in all Quality Assurance tasks

+ Develop and review quality process related Standard Operating Procedures (SOPs) and controlled forms

+ Communicate operational and personal concerns, and opportunities for improvement to the department leadership.

+ Take responsibility for personal skill development in continuing to learn current trends in pharmaceutical standards and best practices of cGMP

+ Knows, understands, and complies with the companys standard operating procedures and?policies

+ To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures

+ Perform?other related job duties or responsibilities as assigned.

+ Review process documentation and contribute to continuous improvements in safety, quality, and efficiency

+ Assist with preparation and execution of internal and 3rd party audits and other reviews

+ Assist with GXP Validation, Qualification and Verification activities

+ Responsible for the review and approval of operational documents, ensuring compliance?to?cGMP and company SOPs

+ Assist the Quality Assurance Manager with QA governance and quality related client meetings for assigned client projects

+ Assist the Quality Assurance Manager with QA governance and quality related client meetings for assigned client projects


Requirements:


+ A minimum of an Associates degree in a relevant scientific field OR a minimum 2 years of work experience in Quality Assurance, Quality Control, or Regulatory Affairs in a regulated (cGXP) organization.

+ Knowledge of relevant cGMP, ISO 9001, and ICH requirements for document control and quality records preferred.

+ Well-organized and detail-oriented with strong technical skills, excellent written and verbal communication skills, and proven ability to multitask.

+ Strong interpersonal skills and the ability to effectively collaborate with others in a dynamic team environment.

+ Capable of supporting multiple projects simultaneously in a deadline-driven environment.

+ Adaptability, flexibility, independence, and resourcefulness to thrive in a fast-paced, small-company environment.

+ High level of proficiency in Microsoft Word, Excel, and SharePoint.

+ High integrity and ethics.

+ Commitment to quality and timely delivery of results.


Physical Requirements:


+ Sit for extended periods of time (2 or more hours)

+ Standing for extended periods of time (2 or more hours)

+ Occasionally lift or carry up to 20 kg


\#P2


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-02 Expires: 2022-10-03

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Quality Assurance Associate Uptown, Seattle

Kelly Services
Seattle, WA 98194

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