Senior Quality Assurance Associate

Job Title: Senior Quality Assurance Associate Location : San Diego, CA- ONSITE Duration: 3 months and may lead to temp to hire Pay: $52.00 / HR Shift: MON-FRI 8AM - 4:30PM Requirements: u2022 Bachelors or Masteru2019s degree in a scientific discipline or relevant equivalent knowledge and experience u2022 10+ years Quality Assurance experience in a GMP manufacturing environment or equivalent experience u2022 Six Sigma or ASQ certification preferred Knowledge/Skills Requirements: u2022 Use existing procedures and established literature to solve routine and non-routine problems u2022 Utilize all elements of the quality system to identify, classify and control the status of finished products produced u2022 Based on broad technical skills and QA experience, anticipates and identifies unmet customer needs u2022 Proactive to address work issues at the individual, team and department level u2022 Ability to follow and provide a variety of instructions furnished in written, oral, diagram or schedule form u2022 Ability to identify and provide guidance/mitigation for aberrant data and potential quality/compliance concerns escalating to management u2022 Lead by example according to Catalentu2019s values and culture u2022 Able to lead difficult discussions with customers and drive them to an acceptable resolution u2022 Provides reliable/defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies u2022 Ability to collaborate with peers and demonstrate leadership capabilities in a matrix environment. The San Diego Clinical and Specialty Services (CSS) Quality Assurance Senior Specialist supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). The Senior Specialist provides regulatory expertise to the investigation and deviation management process. Participates in and maintains site audit readiness by working closely with all departments within the business unit. They ensure that testing methods are validated, equipment is calibrated, and results are accurate and reliable. u2022 Ensures that products are manufactured, packaged, tested and released u2022 Performs document generation and review u2022 Participates in CI projects with risk-based approach u2022 Ensures that products are manufactured, packaged, tested and released according to applicable procedures u2022 Perform product release applicable procedures u2022 Lead investigator for deviations and complaints u2022 Performs document generation and review u2022 Participates in CI projects with risk-based approach u2022 Support functions associated with the packaging of clinical and commercial drug material u2022 Perform batch record review u2022 Participates in CI projects with risk-based approach u2022 Lead investigator for deviations and complaints u2022 Performs in-process audits, line clearance, verification of line clearance. u2022 Performs shipment verification u2022 Assesses incoming damaged material u2022 Participate in document generation and review u2022 Performs annual retain inspections u2022 Lead investigator for deviations and complaints u2022 Participates in CI projects with risk-based approach u2022 Reviews/approves model protocol, randomizations u2022 Performs label approval, print requests, label release u2022 Participates in document generation and review u2022 Lead investigator for deviations and complaints u2022 Tracks metrics for label control. u2022 Participates in CI projects with risk-based approach u2022 Reviews and tracks investigations/ deviations and corrective actions u2022 Participating in reported incidents to support quality compliance and business needs u2022 Assist in data compilation and management support of client business and quality review meetings u2022 Participates in CI projects with risk-based approach 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: 2026-03-20