Description
We are currently seeking qualified professionals for various contract positions with our established corporate clients in the Austin, TX area. While these roles are temporary, they offer a valuable opportunity to gain experience and potentially transition into a permanent position within these reputable organizations.
Kelly Services proudly provides comprehensive health benefits to all contract employees, allowing you to focus on your performance and career development during the engagement. After the contract concludes, you will have the option to reassess your career goals and explore potential internal opportunities.
If you are interested in learning more about these exciting opportunities and how Kelly Services can support your career aspirations, please don't hesitate to contact me to schedule a brief informational call at your convenience. Thank you for your time and consideration.
PAY: $25/hr (DOE)
DURATION: 12 months
LOCATION: On-Site – Austin, TX (Hybrid, 3 days in office, 2 remote following training)
SCHEDULE: M-F 8-5pm
Description:
Individual will work in our client's global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries. Interface with internal customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, public, manufacturing sites, technical support, commercial organization and PV regarding client product complaints. Responsible for product complaint documentation, investigations and identification of potential adverse events and potentially reportable events. Responsibilities may include creation and submission of regulatory reports, creation of customer communications and interface with various third parties.
Responsibilities:
•Assure complaint records meet global requirements.
•Product complaint documentation, investigation, and review of all non-medical complaint content. Responsible for reviewing medical complaints that involve a non-medical quality related problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.
•Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing, and good documentation. Responsible that complaint files meet all regulatory requirements.
•Identification of potentially reportable events and notification to appropriate functional groups and management.
•Interface with Third Party Manufacturers, health care professionals, general public, internal customers, AbbVie functional areas and regulatory agencies.
Qualifications:
•Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
•Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
•Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
•Solid written/verbal communication and organizational skills.
•Knowledge and application of computer systems for word processing and complaint management.
•Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
Education/Experience:
•A Bachelor Degree required. Preferred degree in technology or scientific background (MLT, LPN, RN).
•0-3 years' work experience in a cGMP related industry or in a clinical setting is preferred
• 1 year quality and/or complaint handling experience.
What are the top 3-5 skills requirements:
• Detail oriented
• Microsoft Excel Knowledge and Experience – sorting, filtering are a must
• Adaptive to change
• Self-starter/independent worker
• Taking initiative to improve/create efficiency
#P2
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.
Apply on company website
Find Connections via Linkedin
