Job Purpose: The purpose of this position is to support quality control testing and research and development activities as needed by conducting laboratory testing for raw materials, in-process materials, finished product, and stability samples in accordance with approved analytical methods.
Essential Duties and Responsibilities:
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Conduct routine and complex laboratory testing for raw materials, in-process materials and samples, finished product samples, and stability samples in accordance with approved analytical methods.
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Conduct and execute laboratory work and testing using best-practice analytical techniques and follow laboratory GDP and cGMP requirements
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Accurately analyze and interpret data using appropriate specifications and test methods.
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Accurately peer review notebooks and verify raw data to support sample release, including data generated in electronic software systems.
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Accurately enter data using appropriate reporting systems and release forms.
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Mentor and train Chemists as needed to support laboratory operations.
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Assist in troubleshooting equipment, analyses, etc.
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Support and contribute to investigation documentation, as needed.
Supplemental Functions:
- Relies on instructions and pre-established guidelines to perform job functions.
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Performs other similar duties as required.
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Works under supervision.
Job Specifications and Qualifications:
Knowledge & Skills:
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Strong analytical skills, problem-solving ability, and attention to detail.
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Sound understanding of cGMP regulations pertaining to laboratory controls and thorough knowledge of USP compendia standards.
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Ability to read, understand, review, and update Standard Operating Procedures, Forms, and Specifications and assist in designing new procedures as necessary independently, subject to management guidance.
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Ability to perform testing and lead root cause analysis for laboratory investigations for OOS and atypical QC test results, subject to management guidance.
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Ability to effectively communicate within Chemistry Laboratory Staff and Management, as well as other departments.
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Acknowledge and identify continuous improvement opportunities in all work activities. Initiate and follow through to implement, track, and achieve on-time completion of testing to support sample release to meet business needs and demands.
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Ability to effectively use a multitude of resources to perform job functions accurately.
Education/Experience:
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BS or MS in Chemistry, Biochemistry, or related field required with 2-5 years of pharmaceutical experience preferred. Experience outside of pharmaceuticals in chemistry quality control or R&D will be considered for the highly qualified candidate.
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Experience with conducting analysis by FT-IR, UV/Vis spectroscopy, and wet chemistry techniques is required.
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Highly skilled in advanced techniques such as HPLC, GC, and ICP testing, needing little or no guidance and supervision.
Working Conditions / Physical Requirements:
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This position requires bending, typing, lifting (up to 40 lbs.), standing, sitting and walking throughout the facility.
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This position encounters the following environmental factors: hazardous materials including HPLC solvents, chemical reagents, acids, and other non-specified hazardous materials that are project specific.
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This position requires safety glasses and other non-specified personal protective equipment to be worn as necessary.
