Job Description

Job Purpose: The purpose of this position is to support quality control testing and research and development activities as needed by conducting routine laboratory testing for raw materials, in-process materials, finished product, and stability samples in accordance with approved analytical methods.

Essential Duties and Responsibilities:

• Conduct routine laboratory testing for raw materials, in-process materials and samples, finished product samples, and stability samples in accordance with approved analytical methods.
• Conduct and execute laboratory work and testing using best-practice analytical techniques and follow laboratory GDP and cGMP requirements
• Accurately analyze and interpret data using appropriate specifications and test methods.
• Accurately peer review notebooks and verify raw data to support sample release, including data generated in electronic software systems.
• Accurately enter data using appropriate reporting systems and release forms.
• Supplemental Functions:
• Relies on instructions and pre-established guidelines to perform job functions.
• Performs other similar duties as required.
• Works under supervision.

Job Specifications and Qualifications:

Knowledge & Skills:

• Strong analytical skills, problem-solving ability, and attention to detail.
• An understanding of cGMP regulations pertaining to laboratory controls and knowledge of USP standards.
• Ability to read, understand, review, and update Standard Operating Procedures, Forms, and Specifications and assist in designing new procedures as necessary under management guidance.
• Ability to perform testing for laboratory investigations for OOS and atypical QC test results under management guidance.
• Ability to effectively communicate within Chemistry Laboratory Staff and Management.
• Acknowledge and identify continuous improvement opportunities in all work activities.
• Ability to effectively use a multitude of resources to perform job functions accurately.

Education/Experience:

• BS or MS in Chemistry, Biochemistry, or related field required with 0-3 years of pharmaceutical experience preferred. Experience outside of pharmaceuticals in chemistry quality control or R&D will be considered for the highly qualified candidate.
• Experience with conducting analysis by FT-IR, UV/Vis spectroscopy, and wet chemistry techniques is required.
• Experience in more advanced techniques such as HPLC and GC is preferred.

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 lbs.), standing, sitting and walking throughout the facility.
• 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.
• This position requires safety glasses and other non-specified personal protective equipment to be worn as necessary.

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