Quality Assurance Specialist Job Listing at Kelly Services in San Diego, CA (Job ID 10137579)

Description

Job Title: Quality Assurance Specialist
Location: San Diego CA
Duration: Possible temp to perm after 3 months
Pay: $43.00/HR 
Shift: MON-FRI 8AM - 4:30PM 

Position Overview:
The San Diego Clinical and Specialty Services (CSS) Quality Assurance Specialist I supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements.


Education and Experience:
• Bachelor's degree required or equivalent relevant work experience.
• 5-7 years of relevant work experience in a GMP environment, or comparable pharmaceutical knowledge and experience.
• JD Edwards or comparable ERP systems preferred.
• Minimum of 3 years of customer service experience.
• Proficient knowledge of MS Office software and query-based systems activities (e.g., Pivot Tables, VLOOKUP's, Excel Formulas, building presentations in PowerPoint, etc.).

Knowledge/Skills Requirements:
• Receives instruction, guidance and direction from others
• Uses existing procedures to solve routine problems
• Proactive to address work issues at the individual level
• Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
• Mathematical and scientific reasoning ability
• Ability to identify aberrant data and potential quality/compliance concerns escalating to management
• Ability to work effectively under pressure to meet deadlines
• Sufficient skills and knowledge in the use of computers and associated computer technology (Microsoft Office Software = Outlook, Word, Excel, OneNote, PowerPoint)
• Computer technology relates to both the hardware and software used in performing common computing tasks. (JDE, TrackWise, Smartsheets).
• Proficient in Adobe Acrobat
• Proficiency in all QS I items
• Proficient in JDE
• Able to create Certificate of Analysis independently
• Inspection of bulk drug and finished product
• Adhere to GMP standards routinely with limited errors and limited guidance
• Able to help with investigations
• Able to communicate to other teams about requirements
• Perform effective rapid response
• Subject Matter Expert in JDE related to MMQC processes
• Inspection of all incoming material types
• Investigation and Deviation writing proficient
• Authoring/Updating documents related to MMQC
• Approval of GSA jobs
• Independent release of labels for use
• Approve label prints
• Approve external label request forms
• Verify variable data
• Perform effective rapid response
• Subject Matter Expert in JDE related to label release
• Investigation and Deviation writing proficient
• Authoring/Updating documents
• Assist with DME training for new associates
• Reviewing/approving Deviations and Complaints
• Perform effective rapid response
• Attend/prepare for BRMs
• Client comment resolutions with assistance
• Drive effective rapid responses
• Complaint assessment
• Presentation of Quality items to clients and ELT
• Assist with other site/global quality items
• Authoring/Updating documents
• Train QS I and II associates
• Reviewing / approving engineering studies
• Review/ approval of Periodic reviews and requalification
• Reviewing /approving change controls and change actions
• Perform effective rapid response
• Presentation of Quality items to clients
• Assist with other site/global quality items

Why Kelly?
Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering & scientific talent and services since 1965. And Engineering & Scientific job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.

As a Kelly Services employee, you will have access to numerous perks, including:

• Exposure to a variety of career opportunities as a result of our expansive network of client companies 
• Career guides, information and tools to help you successfully position yourself throughout every stage of your career
• Access to more than 3,000 online training courses through our Kelly Learning Center
• Weekly pay and service bonus plans
• Group-rate insurance options available immediately upon hire*

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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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