Scientific Quality Specialist II Job Listing at Kelly Services in CA (Job ID 9351302)

Description

Location: West Hills, CA
Pay Rate: $42.00
Contract Length: 12 Months

Job Description:             
Quality Specialist II, Post Market Surveillance (PMS) and Stability will provide support in preparation of data analysis, reporting, trending, and documentation review, coordination of complaint and lot qualification data, device history reviews and review and closure of certain categories of complaints. It requires regulatory assessment capability along with MDR/Vigilance reporting. The Post Market Surveillance Specialist may also review and monitor data and document quality, as requested by the manager.

Product Complaints:

• The duties and responsibilities include, but are not limited to the following:
• Review and analyze lot documentation (DHR's) to determine if there are any anomalies that may have related to reported product failures.
• Perform basic product review and failure analysis.
• Prepare risk management plan, facilitate risk analysis and assessment per Risk Management Policy, monitoring and compiling data from adverse events, customer inquiries, complaint records, CAPAs, deviation reports, stability reporting, non-conformance reports, PERs, PCRs, recalls, scientific literature searches, clinical performance, and proficiency testing.

Product Stability:

• Coordinates and performs various stability testing in accordance with stability protocols.
• Ensures stability samples are available and placed in stability chambers at the appropriate time frames to meet the requirements of the stability protocol.
• Ensures stability samples are pulled at the appropriate time frames to meet requirements of the stability protocol.
• Analyzes stability test data utilizing the department stability software program.
• Assists Risk and PMS manager with summarizing stability data for submission into the final stability report.
• Ensures testing and data analysis is completed in a timely manner to meet business and regulatory deadlines.
• Identifies Out of Specification results and notifies manager in a timely manner.
• Notifies manager immediately when adverse stability data trends are identified.
• Ensures stability chambers are maintained and calibrated according to internal and external quality and regulatory requirements.

Product Development Risk Review:

• Document and facilitate product development and change risk reviews.
• Assist with Post Market Surveillance department functions as needed. (Specific duties may vary and will be documented in department records, job assignments and/or project action items).
• Perform computer operations for data entry and provide tracing/trending reports. Abide by corporate policies, procedures and work instructions.
• Assist during FDA, ISO or other third party or internal audits. Other duties as assigned.

Minimum Requirements:

• Bachelor's degree in Biological Sciences or a related field.
• 2 years of experience in a Quality regulated environment.
• Able to create presentations, work with spreadsheets, prepare reports and write procedures utilizing MS Word, Excel and PowerPoint software applications.

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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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 world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's 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

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

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 Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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