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Job Description
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) 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. Excellent Benefits Package Review our company's Total Rewards Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Holidays 401K Company Match up to 5% Tuition Reimbursement - eligible after 90 days! Employee Referral Bonus Employee Discount Program Recognition Program Charitable Gift Matching Company Paid Parental Leave Career Advancement Opportunities
GROUP/DIVISION SUMMARY
The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization. Location/Division Specific Information Greenville, NC
RELOCATION ASSISTANCE IS NOT PROVIDED
Must be legally authorized to work in the United States
WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE.
Must be able to pass a comprehensive background check, which includes a drug screen.
POSITION SUMMARY
Provides routine analyses in a chemistry or microbiology environment by following standard practices. Performs analytical methods as assigned for testing on raw materials, samples, stability, environmental, production intermediates, and/or human cells. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results.
Key Responsibilities:
Conducts routine chemical and physical testing of active pharmaceutical ingredients, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods. Performs validated test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and traditional quantitative analysis, using HPLC, GC, dissolution, spectroscopy, and/or traditional wet chemical testing. Recognizes and reports out-of-specification (OOS) or unexpected results (UR) and non-routine analytical and product problems. Performs daily instrument calibrations / verifications as needed. Clearly and accurately communicates the results of work by crafting documentation of the testing/analysis and acquired results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. Reports or makes determination of OOS or UR results and analytical problems to reach resolution Participates in writing of SOPs if needed. Cleans and maintains work area, instrumentation, and testing materials. Cleans HPLC and dissolution systems after use. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, ALCOA, Audits and Safety guidelines. Maintains compliance status required by company and facility standards.
Qualifications:
Bachelor's degree in physical science, preferably in Chemistry or Biology preferred. Equivalent combinations of education, training, and relative work experience. 2 years of job-related experience: i.e. performing chemical tests with chromatographic, spectroscopic, or other analytical technique required if you have an Associate degree. Problem Solving and Interpersonal proficiencies (Oral and Written- Legible handwriting) Knowledge of qualitative and quantitative chemical or microbiological analysis and instrumental technologies. Awareness of quality and technical procedures and regulatory requirements in the pharmaceutical industry. Exhibits logical approach to solving scientific problems. Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques. Position requires ordinary ambulatory skills and physical coordination, including dexterity, sufficient to move about office locations. Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
