Kelly Services Research Associate in Fort Collins, Colorado
Research Associate -
4-5 month Temp
24.50 per hour
Purpose and Scope
Under general supervision the analyst perform routine sample analyses, data review, document review, test method development, and test method validation. The analyst uses in-house standard operating procedures and pharmaceutical industry knowledge. The analyst fosters an environment of safety and company culture.
Essential Duties Responsibilities
Apply regulations for drugs and medical devices, including USP, ICH and FDA regulations for cGMP and GLP with minimal guidance.
Adhere to validated test methods, standard operating procedures, and applicable industry guidance. Independently perform routine sample analyses in support of GLP and/or R & D stability protocols.
Analyze samples of drug product, drug substance, and/or excipients.
Assist other departments in analyzing samples, as requested.
Maintain and review laboratory notebooks according to cGMP standards and in-house standard operating procedures SOPs .
Record detailed observations.
Tabulate, analyze, review, and interpret data from analytical tests.
Perform analytical test method development, qualification, and validation.
Perform equipment troubleshooting, maintenance, and minor repairs.
Assist the Quality Control QC laboratory in troubleshooting test method issues.
Write and review technical reports, summaries, protocols, test methods, standard operating procedures, and other documents for product development. Use technical discretion in the execution, and interpretation of experiments that contribute to project strategies.
Participate in required trainings.
Serve as contact for vendors and contract laboratories as needed.
Interact closely with project teams and across departments.
Learn to mentor, train, and coach others.
Provide analytical support to Formulation Development and interact with team members.
Participates in required annual hazardous waste training.
Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes, and transfer of hazardous waste between lab procedure area, satellite accumulation, and storage.
Responsible for daily activities and supervising staff that are hazardous waste generators and/or handlers.
Respond to spills according to the Chemical Spill Response procedure.
Perform other related duties as assigned. Knowledge, Skills Abilities Knowledge
Experienced in the operation of analytical laboratory instruments such as HPLC, GC, FTIR, pH, GC, UV-Vis spectrophotometry, TLC, Karl Fischer titration, rheometry. Experience with sample preparation from a variety of matrices. Working understanding of FDA regulations, USP, NF, ICH, EP, and other pertinent compendia. Experience in the effective writing and accurate review of technical reports, summaries, protocols, test methods, standard operating procedures, and other documents for use in the company or for submission to government agencies. Basic understanding of drug product formulation development Skills Experience with laboratory and wet chemistry techniques e.g. weighing, volumetric glassware, titrations, etc.. Experience in equipment troubleshooting, maintenance, and repairs. Experience with method development and validation. Effective written and oral communication skills. Experience with use of electronic document management systems. Experienced with use of word processing, spreadsheet, and database programs. Experienced with MS Office. Experience with computer systems for sample tracking, laboratory equipment, and raw data handling. Abilities Learn and apply new techniques Attention to detail. Accurate and consistent in data compilation and review. Demonstrate ability to work independently, with other analysts, and handle multiple projects and timelines concurrently.
Why Kelly ® ?
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ® ) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm