Analytical Scientist II: Method Dev & QC in GMP Lab

Ampac-Fine-Chemicals-1

Rancho Cordova (CA)

On-site

USD 75,000 - 85,000

Full time

14 days+

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Job summary

Ampac-Fine-Chemicals-1 in Rancho Cordova, CA is seeking an Analytical Scientist II to perform entry-level chemical analysis of pharmaceutical compounds, and to develop and validate analytical methods using HPLC, GC, KF, LCMS, and related techniques. You will write technical reports, perform data review, and support transfer of methods within a GMP environment.

The role is full-time and not remote or hybrid.

Qualifications

Bachelor’s or Master’s degree in Chemistry or related field.
2–5 years in quality control, method development, validation and transfer.
1–2 years in a cGMP environment preferred.
Knowledge of HPLC, GC, KF, LCMS, GCMS and wet chemistry techniques.

Responsibilities

Executes method development, validation, and transfer protocols and procedures to support the analytical team using HPLC, GC, KF, and a variety of other instruments and techniques.
Drafts method validation and transfer protocols for execution in the analytical team
Analysis of bulk chemicals and pharmaceutical compounds which require a comprehensive knowledge of chemistry and laboratory techniques, in a quality GMP environment.
Compilation of data obtained from analytical tests and validation, analysis of the data, and drafting reports summarizing results
Conducts peer review of data including laboratory notebooks, forms and through various laboratory software systems
Conducts peer review of reports before issuance to customers and stakeholders
Drafts methods used for testing in analytical and QC laboratories.
Write Quality Control Reports (QCRs) documenting deviations and laboratory events and assessing corrective and preventative actions.
General housekeeping including maintaining general cleanliness of laboratories and restocking reagents and laboratory consumables.
Develop methods for typical analytical techniques including HPLC, GC, KF and other wet chemistry techniques
With guidance, develop methods for non-standard techniques including various MS techniques, non-standard chromatography and other techniques
With guidance, draft specifications for testing raw materials, in-process control, intermediate and final product compounds
Participate in the change control process, including revision of documentation and tracking approvals
May be responsible for leadership of an on-going or limited scope project.
May be involved in interfacing with customer at times, including communicating results and status.
May participate in integrated product team (IPT) meetings, providing updates on status of methods, specifications, and other analytical activities.