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Chemist III
Job Description
Sirius Staffing is seeking a Senior Chemist for a Direct Hire role in Charles City, Iowa. Please contact Sirius today for more information in regard to this position.
Salary:
70-80k
Responsibilities:
• Follow all FDA, ICH, cGMP, cGLP, DEA, and internal SOP requirements as they relate to Phase III and commercial GMP laboratory operation.
• Adhere to all OSHA and company safety requirements and practices.
• Perform a wide variety of chemical analyses for release of raw materials, in-process, intermediates, finished goods, and stability.
• Support/maintain laboratory programs such as calibration/preventive maintenance, IQ/OQ/PQ.
• Perform in-depth out-of-specification or out-of-trend laboratory investigations of non-compliant or aberrant results.
• Support the implementation and training efforts for new laboratory instrumentation or software.
• Perform data review of QC data as necessary.
• Independently perform troubleshooting of laboratory equipment.
• Strong working knowledge of HPLC, UPLC, GC, and GC-HS.
• Working knowledge of wet chemistry.
• Write controlled documents such as reports, test procedures, SOPs, etc.
• Evaluate the validity of test results.
• May assist in training employees within the department. Topics may include, but are not limited to, instrumentation, analytical concepts, or equipment troubleshooting.
• Perform and document method transfer from Analytical Development. May perform method evaluation experiments as necessary.
• Handle, analyze, and dispose of hazardous samples and waste.
• May need to provide off-shift coverage as required.
• Maintain laboratory solutions, inventory, and notebooks utilizing a LIMS.
• Coordinate and communicate project status with a proven ability to handle various assignments and organize workload to meet timelines.
• May interact with outside vendors and other departments. • Extensive knowledge and proven ability to use a wide assortment of the analytical instrumentation available at the facility.
• Proven ability to handle various assignments and organize workload to meet timelines.
• May act as departmental subject matter expert (SME). All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.
Qualifications/Skills:
• Working knowledge of analytical instrumentation (GC, HPLC, and UPLC).
• Working knowledge of MS, NMR, XRPD, IC, and ICP-OES preferred.
• Strong chemistry theory.
• Proven ability to handle various project loads with strong attention to detail.
• Ability to work in a fast-paced, deadline-driven work environment.
• Effective communication skills (oral, written).
• Ability to work independently with little or no direct supervision.
Education, Experience & Licensing Requirements:
• BS/BA in Chemistry/Biology or related science field required
• Advanced degree (MS, PhD) in Chemistry/Biology or related science field preferred
• Minimum of 6-7 years (with a BS) or 5-6 years (with an advanced degree) of direct laboratory experience with chromatographic techniques in an industry-related setting. Preferably in pharmaceutical manufacturing.
• Strong cGMP experience.
• Experience testing against USP and EP compendia
Sirius Staffing is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to characteristics such as race, color, national origin, religion, gender, age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity, or any other status protected by law.
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About Charles City, IA
Discover exciting job opportunities in the vibrant area around Charles City, Iowa! Nestled in the heart of the Midwest, this charming town offers a welcoming community, stunning parks like Wildwood Park and the unique chance to explore the iconic Floyd County Museum. With a rich culture that includes renowned art galleries like the Mooney Art Collection and engaging performances at the historic Charles City Community Theater, there's no shortage of inspiration here. Embrace the chance to join this thriving region that celebrates its local flavors, from the delightful cuisine at North Iowa's Old School BBQ to the popular Charles City Farmers Market. Start your career journey in this dynamic area and unlock a world of growth and opportunity!