Kelly Services Scientist, Biological Quality Control in Fort Dodge, Iowa
Kelly Science and Clinical is the world’s most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.
We are seeking a Scientist, Biological Quality Control for one of our clients, a leading global animal health company that delivers innovative products and services to improve the health of pets and farm animals around the world.The Bio Quality Control group is responsible for performing bio-analytical methods (immunological, in vivo, microbiological, molecular biological, or virologic) for various Bio QC tests on raw materials, in-process, release, or stability samples in compliance with 9CFR, EU and VICH regulatory guidelines, Outlines of Production and Special Outlines.
The incumbent will initiate, execute, and complete assays as per approved procedures and within Quality and Compliance guidelines.
The Sterility area also performs and maintains the area disinfection schedule as appropriate to the room Level.
The incumbent is responsible for timely communication with managers to inform them of testing, compliance and/or scheduling issues, adhering to company policies, maintaining a safe work environment through Site safety KPIs, and following appropriate GMP documentation.
Additional duties are based upon the incumbent’s level and experience. This position will perform all testing, cleaning, and aseptic assessments as required by area procedures, i.e.: working Supervisor.
A bachelor’s Degree in a relevant scientific discipline OR equivalent experience in lieu of degree
2-3 years relevant work experience (lab/manufacturing/supervisory)
Business and/or technical knowledge developed through education or past experience.
Thorough understanding of bacterial culture maintenance, aseptic technique, and good
Thorough understanding of scientific concepts and principles and complex lab techniques. Ability to manage portions of major projects with supervision or minor projects independently.
Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Develop/validate methods and processes. Performs and documents work following established methods, SOP’s and/or GXP. Good understanding of applicable regulations and impact to project and/or business.
Able to interact with regulatory agencies. Comprehensive understanding of processes in immediate area and familiarity of processes in other areas. Makes routine decisions with limited guidance from supervisor.
Recognizes and reacts to the significance of data/results. Able to effectively communicate procedures, thoughts and ideas in a clear concise and appropriate manner within and outside of own department. Communicates with cross-functional groups.
Documents and reviews lab results/data as required by applicable SOP’s and methods. Organizes data generated for inclusion in reports.
Write and revise SOP’s, methods, and protocols. Works and interacts mainly within own group to complete tasks assigned.
Able to train others on methods and routine lab work.
Cooperates and shares information with other groups and departments to accomplish goals. Contributes original suggestions and acts independently to find answers and solutions.
Ability and willingness to jump into the laboratory to help with ALL process and cleaning duties to ensure daily tasks are completed as required.
Maintain inventories of reagents and supplies. Operate and maintain calibrated standard equipment. Maintain a clean and orderly lab.
Conduct testing: Sterility, Mycoplasma, Potency, and numerous miscellaneous testing per method.
Maintain disinfected and sanitized area by following specific room cleaning procedures.
Perform testing using a significant portion of the existing laboratory assays.
Prepare reagents and materials
Communicates schedule, test status and concerns.
Write Laboratory Investigations or deviations, and area reports, as needed.
Writes change controls as needed.
Review and approve results and test sheets for compliance to regulations.
Enter results into SAP and/or complete second verification.
Revise pre-existing Standard Methods and SOPs.
Create New Standard Methods, SOPs, Protocols.
Trains others on methods & procedures.
Coordinate projects within group or department with little supervision using strategic planning.
Coordinate projects with different departments with little supervision using strategic planning.
Analytical thinking and problem-solving resolution.
Understands complex situations, issues, or systems. Evaluate the impact of changes.
Supervise small group of people, conduct routine performance discussions, maintain scheduling through adversity.
Understand the complex nature of supervising and running a laboratory with outside limiting factors.
You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.
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 ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
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.
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