QC Particulate Scientist II

Nature and Scope

The QC Particulate Scientist II will demonstrate proficiency in advanced techniques and expertise with particle isolation, manipulation and particle forensics supporting product investigations, process evaluation, examination of customer complaint CRU, source particle characterization and mitigation programs, and R&D container closure studies and will play a supporting role in method development, creation and certification of test sets, and routine analyses for product release by USP <788> & <790>.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Tracking/documentation of incoming samples.
• Prepare laboratory reagents for particulate analysis
• Operate analytical instruments (ie: SEM/EDS, FTIR, Flow Microscopy)
• Perform USP <788> & <790> analyses.
• Perform forensic analysis on unknown particulate samples.
• Perform verification of sulfur treatment on incoming glass
• Document all data generated from analyses following GDP.
• Assist with data entry for analysis and trending.
• Support the creation and certification of test sets
• Order and track laboratory supplies.
• Clean and disinfect laboratory spaces/work areas.
• Assist in the characterization of particulate matter.
• Perform routine analysis of final dosage forms and stability samples.
• Assist in the IQ/OQ/PQ of new laboratory equipment (e.g., new particulate matter systems)
• Assist in the performance of investigations.
• Maintain laboratory equipment (e.g., particulate systems, SEM/EDS, FTIR, Flow Microscopy).
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelor’s degree in a scientific discipline required.
• Minimum of 3 years in a Quality laboratory environment required.
• Aseptic processing experience preferred.

Physical Environment and Requirements

• Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.

Expected Salary Range:

$79,900-86,000

The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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