QA RA Compliance Specialist

Job Title: QA RA Compliance Specialist Location : Saint Petersburg, FL - ONSITE Duration: 6 months with possible extensions Pay: $30.00 / HR Shift: MON-FRI 8AM - 5PM OR 9AM - 6PM. Position Overview: u2022 Coordinate, Track, and Trend Change Controls issued for the facility. Ensuring change controls meet the initial requirements for implementation and reviewing completed change controls to ensure all actions have been appropriately completed. u2022 Provide initial regulatory impact assessment on all change controls as required. u2022 Liaise with customers to ensure customer requirements are satisfied. u2022 Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required u2022 Prepare and submit all federal, state and local permits in timely manner u2022 Interact with Customers and gather information as needed to support registration activities u2022 Assist in the preparation of standard operating procedures (SOPs) associated with job function; review and approve SOPs requiring the regulatory function participation under direction of the Group Leader u2022 Assist in regulatory/health authority audits collecting information as requested u2022 Collaborates with Subject Matter Experts (SME)s, management and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation, following up on issues and a working jointly towards resolution u2022 Prepare APRs in accordance with site procedures and timelines. u2022 Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure. u2022 May author other types of quality system documents as directed or assigned by QA management. u2022 Other duties as required in support of Catalent Pharma Solutions high performance, such as but not limited to, assisting site management in driving and enforcing cGMPs; mentoring other individuals within the organization in compliance; participating in Internal Assessments; facilitating routine compliance and CAPA Review Board meetings, including follow up actions; facilitating and conducting training. u2022 Assist in complying with any other company and /or departmental objectives as directed by the Group Leader u2022 Assist in other special projects as assigned Education or Equivalent: u2022 Bacheloru2019s Degree in Science or related field required (Chemistry, Microbiology or Biology); u2022 A minimum of 3 years related experience in the pharmaceutical manufacturing industry. u2022 Strong background working with Change Controls and management of change control processes. u2022 Prior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred). u2022PathWise Certification preferred. Knowledge/Skills Requirements : u2022 Prior regulatory affairs, quality control or quality assurance experience is a must. u2022 Working knowledge of US application regulations and cGMPs, and FDA Guidance for both. u2022 Excellent organization skills and extreme attention to detail are a must. u2022 Excellent oral and written communication skills. u2022 Motivated, self-started, team player. u2022 Able to reflect a strong quality work ethic. u2022 Proven ability to multi-task and demonstrate diplomatic skills. u2022 Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint, Access). u2022 Working knowledge of cGMPs and/or OSHA regulations required. 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: 2026-04-04