Quality Assurance Specialist

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: u2022 Bacheloru2019s degree required or equivalent relevant work experience. u2022 5-7 years of relevant work experience in a GMP environment, or comparable pharmaceutical knowledge and experience. u2022 JD Edwards or comparable ERP systems preferred. u2022 Minimum of 3 years of customer service experience. u2022 Proficient knowledge of MS Office software and query-based systems activities (e.g., Pivot Tables, VLOOKUPu2019s, Excel Formulas, building presentations in PowerPoint, etc.). Knowledge/Skills Requirements: u2022 Receives instruction, guidance and direction from others u2022 Uses existing procedures to solve routine problems u2022 Proactive to address work issues at the individual level u2022 Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form u2022 Mathematical and scientific reasoning ability u2022 Ability to identify aberrant data and potential quality/compliance concerns escalating to management u2022 Ability to work effectively under pressure to meet deadlines u2022 Sufficient skills and knowledge in the use of computers and associated computer technology (Microsoft Office Software = Outlook, Word, Excel, OneNote, PowerPoint) u2022 Computer technology relates to both the hardware and software used in performing common computing tasks. (JDE, TrackWise, Smartsheets). u2022 Proficient in Adobe Acrobat u2022 Proficiency in all QS I items u2022 Proficient in JDE u2022 Able to create Certificate of Analysis independently u2022 Inspection of bulk drug and finished product u2022 Adhere to GMP standards routinely with limited errors and limited guidance u2022 Able to help with investigations u2022 Able to communicate to other teams about requirements u2022 Perform effective rapid response u2022 Subject Matter Expert in JDE related to MMQC processes u2022 Inspection of all incoming material types u2022 Investigation and Deviation writing proficient u2022 Authoring/Updating documents related to MMQC u2022 Approval of GSA jobs u2022 Independent release of labels for use u2022 Approve label prints u2022 Approve external label request forms u2022 Verify variable data u2022 Perform effective rapid response u2022 Subject Matter Expert in JDE related to label release u2022 Investigation and Deviation writing proficient u2022 Authoring/Updating documents u2022 Assist with DME training for new associates u2022 Reviewing/approving Deviations and Complaints u2022 Perform effective rapid response u2022 Attend/prepare for BRMs u2022 Client comment resolutions with assistance u2022 Drive effective rapid responses u2022 Complaint assessment u2022 Presentation of Quality items to clients and ELT u2022 Assist with other site/global quality items u2022 Authoring/Updating documents u2022 Train QS I and II associates u2022 Reviewing / approving engineering studies u2022 Review/ approval of Periodic reviews and requalification u2022 Reviewing /approving change controls and change actions u2022 Perform effective rapid response u2022 Presentation of Quality items to clients u2022 Assist with other site/global quality items Why Kelly? Kellyu00ae 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 Kellyu00ae 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 Kellyu00ae 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 u00ae 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 worldu2019s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsu2014itu2019s 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, weu2019re obsessed with where it can take you. To us, itu2019s about more than simply accepting your next job opportunity. Itu2019s the fuel that powers every next step of your life. Itu2019s 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 lifeu2014just 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 Californiau2019s 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.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 Kellyu2019s Human Resource Knowledge Center. Kelly complies with the requirements of Californiau2019s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Created: 2026-02-25