Senior Clinical Research Associate
Remote, United States · remote
Salary not posted
Work Schedule 12 hr shift/nights Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through to commercialization. How You Will Make an Impact A successful person will perform Environmental Monitoring tasks in support of Steriles production within classified areas. The individual is encouraged to follow the 4i Values that are held in high regards by the company when completing their work. The four values are integrity, innovation, intensity, and involvement. The job function includes aseptic technique which requires the individual to gain knowledge of aseptic gowning as well as working in cleanrooms in order to monitor the area while sterile products are filled and manufactured. Typical shift hours are 6p-6a on a 2-2-3 rotating schedule. A Day in the Life Perform analyses including instrumental and automated methods using prescribed procedures and techniques. Generate valid data, report results on appropriate database compared to established specifications while adhering to GMPs. Compare laboratory results with specifications for acceptability and determine if repetition or OOS is required. Maintain equipment and troubleshoot instrumentation problems, procedural problems or production problems. Review and understand SOPs and analytical procedures as needed. Schedule activities to meet target dates for customer needs. Follow all job-related safety and other training requirements. Performs tasks as assigned by area supervision or designee. Able to withstand extended periods of standing and/or walking and bending. Qualifications: *Must be Legally authorized to work in the United States without sponsorship. *Must be able to pass a comprehensive background check to include drug screening. Education Bachelor’s degree in a biology/ related field is preferred. An associate's degree in a science related field, preferably Biology, is minimally required. Experience 1+ years related experience performing chemical tests with chromatographic, spectroscopic, or other analytical techniques, working knowledge of EMPOWER is a plus. 2 years of experience preferred. Knowledge, Skills, and Abilities Knowledge of MS Excel, Word, and Access and is familiar using each program. Excellent problem solving and critical thinking skills are a plus when performing this job. Organization and detailed planning skills are seen as major pros for this job function. Strong attention to detail and ability to follow standard procedures As our supported area of the company is a fast paced environment a person who enjoys a constantly evolving environment will do well. Good knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs are a plus. Good interpersonal and communication skills (both oral and written). Ability to apply mathematical operations
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Remote, United States · remote
Salary not posted
Florida, US · onsite
Salary not posted
Mason, OH; Minnetonka, MN · hybrid
$106k–$125k