Job Title : Research Associate II

Location : Tucson, AZ

Type: Contract, Potential for extension or conversion to permanent

Overview

This is a role in Stability & Surveillance (S&S) in Oncology Assay Development (OAD) organization. The team is responsible for real-time stability testing to support expiration dating of company reagents, as packaged under recommended storage conditions, to ensure that label claims are met throughout a product’s shelf life. The stability team members work closely across various Pathology Customer Area (RTD) functions, including Tissue procurement & Histology (BAM), Medical Office, Development, Lifecycle, Investigation & Resolution, Manufacturing, Quality, Regulatory, and Global Organizations.

This individual will primarily perform the supporting (Tissue Qualification) activities necessary for monitoring of the commercial products as packaged under recommended storage conditions over a period. Activities may include tissue qualification & block search process; stability testing to confirm that products meet specifications; data management; participating in evaluating and reporting results; generating required documentation/procedures/technical reports in support of daily activities. Additional tasks/projects may be assigned based on team needs. This individual will mainly interact with internal stability team members, Pathology/ Medical office, and Tissue (Bio-specimen) Management; interactions with other cross-functional groups will be dependent on special circumstances or assignments.

Requirements

Education/Experience:

• Bachelor’s Degree in Science required

• Degree in Biology, Biochemistry, Chemistry , Molecular Biology, Microbiology preferred

• 2 years of relevant job experience required

• Background in immunohistochemistry, histology/pathology, pharmaceutical chemistry, analytical chemistry, biology, biochemistry, or biomedical engineering preferred

Knowledge, Skill or Ability:

• Laboratory experience, familiarity (hands-on experience) with laboratory techniques is strongly preferred (pipetting, making dilutions )

• Ability to follow Quality System regulations, including Design Control, Stability protocols, Scientific study design

• Ability to work independently, independent thought process and take directions well

• GDP (Good Documentation Practice), Good record-keeping, and GLP (Good Lab Practice)

• Must have the ability to adhere to design control procedures in compliance with FDA and ISO guidelines

• Good organization skills, Good Communication skills, Time Management skills, Attention to details required

• Skilled at using Microsoft Word, power-point and Excel

• Good Technical writing (writing protocols and reports) and Oral presentation skills preferred

• Experience from the medical device and/or pharmaceutical industries is preferred

• Project management experience is preferred

• Quality Control background is preferred

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.