24 days old

Quality Assurance Engineer

Kelly Services
Los Angeles, CA 90006
Quality Assurance Engineer

6 month contract

Up to 56 an hour

Los Angeles, CA

This will be a Quality Assurance Associate position supporting site Critical System, Engineering and Facilities

This position will be part of the QA organization primarily responsible for the Critical Systems, Facilities, and Engineering support for the Los Angeles Facilities.

The incumbent will provide quality assurance decisions to daily operations and assure compliance with current GMP, GDP, GLP, and company procedures. The incumbent will identify and assess regulatory compliance and quality risks in activities and processes according to regulatory agency guidelines and Takeda Quality practices.

The incumbent will help evaluate, plan, develop, and lead improvements and compliance projects relating to areas of responsibility. The incumbent will provide support to investigations in addition to review and approval of OOL, OOS, OOT, and deviations. The incumbent will also provide quality assessments, reviews, and approvals for changes in accordance with internal procedures and ensure compliance with the regulatory requirements.

The incumbent will review and approve document changes and represent quality in project groups and support/lead continuous improvement initiatives.

The incumbent will provide technical knowledge and/or support investigation teams in troubleshooting / problem solving activities as applicable. Provide recommendations for decisions of systems and results of moderate complexity. The incumbent should be a self-led individual that works under only very general supervision to meet deadlines/goals.

Partner with manufacturing or areas of responsibility to ensure sound quality decisions are made.

Provide oversight to ensure a GMP area is maintained for the Critical Systems, Facilities and Engineering area.

Performs review and approval of Level 1 and Level 2 Deviations/CAPAs as assigned.

Provide guidance on Product Impact Assessments

Perform review and approval of insignificant change controls to ensure change packages are accurate and meet requirements set forth.

Review and approve as required, CTPs and SOPs. Review or draft memos, reports, protocols, and other appropriate documentation as they pertain to department operations and procedures.

Identify areas for improvements to mitigate recurring non-conformances and drive continuous improvement.

Lead or support ongoing daily department activities across all shifts for Critical Systems and when required assist other Quality areas in the successful performance of these activities.

Be directly involved in and lead multiple process/product improvement projects. These projects may be executed through CAPA, QWT, Kaizen, or other focus groups, design of experiments, studies, data generation and analysis, report preparation, presentations, and/or change control.

Assist in department with audit ready status efforts in understanding FDA, Shire, and other regulatory and quality requirements. Maintain a high level of expertise in current regulatory requirements and serve as a resource for compliance to these requirements.

Drive Lean principles such as 5S throughout daily work activities.

Demonstrated track record of managing multiple tasks and projects concurrently and driving projects to completion in a timely manner.

Strong organizational skills and ability to plan and suggest resolutions to technical problems.

Strong understanding of critical laboratory, manufacturing and facility processes

Be able to recommend different technical strategies and analyses during investigations.

Capable of applying decisions-making to problem-solve technical, compliance, or operational problems as assigned.

Represent department through technical presentations, projects, and other department initiatives as assigned.

Working knowledge of regulatory guidance i.e. CFR and USP.

Computer literate and competent with an effective knowledge of word processing and spreadsheets (such as Microsoft Office). Capable of performing data analysis through various applications software.

Thorough knowledge of quality system processes.

Strong leadership skills.

Demonstrate Shire Leadership behaviors -positive, accountable, results driven, and excellent manager of self and others

Good verbal and written communication skills.

Success working with multifunctional, global teams.

Good interpersonal, influencing, and negotiation skills required.

Be able to provide technical review of investigations.

Be able to work independently and with limited supervision.

Typically requires bachelor's degree in engineering, chemistry, biological science, or other related technical field. 3+ yrs of related experience.

Must be able to lift, push, pull and carry up to (25lbs).

In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.

No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

Will work in a cold, wet environment

Must be able to work multiple shifts, including weekends.

Some travel may be required.

Must be able to work overtime as required.

May be required to work in a confined area.

Some Clean Room and cool/hot storage conditions.

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**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. 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 is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Posted: 2020-11-11 Expires: 2020-12-12

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Quality Assurance Engineer

Kelly Services
Los Angeles, CA 90006

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