Description
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
- ✓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.
- ✓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.
- ✓Mentor and train Chemists as needed to support laboratory operations.
- ✓Assist in troubleshooting equipment, analyses, etc.
- ✓Support and contribute to investigation documentation, as needed.
Supplemental Functions
- ✓Relies on instructions and pre-established guidelines to perform job functions.
- ✓Performs other similar duties as required.
- ✓Works under supervision.
Requirements
Job Specifications and Qualifications
Knowledge & Skills
- ✓Strong analytical skills, problem-solving ability, and attention to detail.
- ✓Sound understanding of cGMP regulations pertaining to laboratory controls and thorough knowledge of USP and compendia standards.
- ✓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.
- ✓Ability to perform testing and lead root cause analysis for laboratory investigations for OOS and atypical QC test results, subject to management guidance.
- ✓Ability to effectively communicate within Chemistry Laboratory Staff and Management, as well as other departments.
- ✓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.
- ✓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 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.
- ✓Experience with conducting analysis by FT-IR, UV/Vis spectroscopy, and wet chemistry techniques is required.
- ✓Highly skilled in advanced techniques such as HPLC, GC, and ICP testing, needing little or no guidance and supervision.
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.