Job Description
POSITION SUMMARY : Piramal Pharma Solutions' HPAPI Research and Manufacturing facility, located in Riverview, Michigan (Ash Stevens, LLC, hereafter referred to as PPS-Riverview), is seeking a qualified
Analytical Chemist to join our Stability and Reference Standard team. The Analytical Chemist is responsible for providing analytical support to the stability and reference standard programs.
To perform this position 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: - Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
- Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
- Identify and protect the original technical information as part of the company property.
Key responsibilities. - Perform testing on stability samples and reference standards to meet program/client timelines.
- Responsible for ensuring completion of testing and recording the tracking and trending of test results.
- Assist in the preparation of stability protocols and final reports.
- Responds to customer request for information concerning stability studies and reference standards.
- Shipping stability and reference samples to external sites for testing.
- Initiating and completing deviations, CAPAs, and change controls related to the stability and reference standard programs.
- Assist in the maintenance and calibration of laboratory analytical instrumentation including, but not limited to HPLC and GC. Maintain accurate records regarding the maintenance and calibration activities.
- Assist in the maintenance of the QC Laboratory. In addition to routine housekeeping and glassware cleaning, maintains and appropriate inventory of supplies and chemicals.
- Document sample preparation, equipment set-up and test results in Laboratory Notebooks or on the appropriate test record form. Documentation must be complete and verified by a second member of the quality group. In addition, laboratory log sheets, those related to equipment usage, calibration, and maintenance, reference standard inventory, QC chemical inventory, or those related to retention samples will be properly maintained.
Education/Experience. The successful candidate must meet one of the following education/experience combinations:
- Master's Degree and 1-3 years' experience; OR
- Bachelor's Degree and 4-6 years' experience in a related environment.
Job Competencies. - Knowledge of analytical testing and instrumentation
- Excellent organizational and planning skills.
- Strong written, verbal, and interpersonal communication skills.
- High attention to detail.
- Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines.
- Proficiency with Microsoft Office Suite and industry-related software (Agilent ChemStation, etc).
Job Tags
Full time, Work at office,