QC Scientist II
About the Job
Provides moderately complex analyses in a chemistry or microbiological environment within defined procedures and practices. Performs analytical methods for moderately complex testing on raw materials, samples, stability, production intermediates, environmental monitoring, sterility tests, growth promotion, microbial limits tests, and/or and antimicrobial effectiveness tests. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results; recommends solutions.
What will you do?
Verifies and processes analytical data. Facilitates development of quality products through participation and representation on group and department level project teams.
Conducts moderately complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods.
Leads the validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and traditional wet chemical testing. Determines which methods will be used.
Reports or makes determination out-of-specification or unexpected results and analytical and product problems to reach resolution.
Maintains and troubleshoots analytical instrumentation as needed. Performs audits on equipment periodically to verify proper calibration and use.
Develops documentation processes. Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. Interacts with clients directly.
Leads, prepares, and files regulatory documents in support of internal projects. Provides communications with outside departments, corporate sites, agencies, and clients.
Coordinates and assists or leads, prepares and files with writing of SOPs, policy manuals, and other instructional documents.
Cleans and organizes 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 the necessary compliance status required by company and facility standards.
Bachelor’s degree preferred in physical science, preferably in Chemistry or Biology. Associate degree in a chemistry or biology related displine required.
Requires a minimum of 3 years of experience. Performing tests or analyses for pharmaceutical raw materials, finished products, or microbiological samples. Experience with common office software and chromatographic data acquisition systems preferred.
Skills and Competencies:
Problem Solving Skills
Communication Skills (Oral and Written)
Good knowledge and understanding of chemistry and analytical instrumental technologies. Good knowledge of qualitative and quantitative chemical or microbiological analysis. Good knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry. Good problem solving skills and logical approach to solving scientific problems. Proficiency with HPLC, GC, LC/MS and Dissolution techniques.Good presentation skills to present information to customers, clients, and other employees. Ability to read, analyze, and interpret technical procedures and governmental regulations. Ability to write standard operating procedures, simple protocols, and reports. Ability to respond to common inquiries or complaints from customers or regulatory agencies. Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance and correlation techniques.
Equivalent combinations of education, training, and relevant work experience may be considered if you at least have an Associate's degree.
Manages assigned asks with little oversight and takes initiative (i.e. problem solves unprompted). Provides technical guidance to others.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged, periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.