Chemistry Analyst

Chemistry Analyst

Must successfully pass background and drug screen

Summary:

The Chemistry Analyst is responsible for the accurate and efficient execution of laboratory tests via HPLC/UPLC instruments. Candidates in this position will collect and present data in a well-reasoned and accurate manner and maintain the laboratory environment according to cGMP guidelines.

Essential Duties/ Responsibilities:

Preparation of pharmaceutical samples to determine potency primarily using HPLC analytical methods and some wet chemistry techniques.
Provide accurate test results on a timely basis.
Maintains control of test samples during the testing lifetime. This includes storage, transport, testing, and disposal.
Reports any Deviations and/or Nonconformities to Management.
Engages in laboratory Quality Event investigations when applicable.
Identify risks to efficiency and safety and provide feedback to management.

Education:

Bachelor's degree (B.S./B.A.) in Chemistry, Biology, Biochemistry, or a related field (required). BS in Chemistry/Biochemistry from a certified ACS program (preferred).

Experience:

0-3 years of experience in an analytical laboratory setting.
2+ years of experience using HPLC or ICP-MS to determine assay/potency results.
2+ years of experience testing heavy metal analysis using ICP-MS.
Experience with basic wet chemistry tests and methods such as titrations.
Highly organized and able to manage multiple tasks in a fast-paced environment.
A fast learner, self-starter, mature, personable, and relates well to people at all levels.
Strong knowledge of a variety of analytical instrumentation.
Hands-on experience with a variety of analytical instrumentation that includes but is not limited to HPLC, ICP-MS, and FTIR (preferred).
Has knowledge and understanding of ISO/USP standards and guidelines (preferred).
cGMP laboratory experience (preferred).
Efficiency using Chromeleon or Total Chrom software (preferred)

Requirements - Intermediate Level:

Controlled substances knowledge(DEA).
Familiar with performing method validations following a protocol, technical writing for SOPs, Validation Protocols, or reports.
Hands-on experience developing methods for HPLC assays/potency tests, and developing methods for ICP-MS heavy metal tests.
Proficiency with stability-indicating methods using forced degradation studies.
Experience with ICP-MS and HPLC maintenance, troubleshooting, and instrument qualifications.
Knowledge of USP & ISO standards, guidelines, and validation requirements per USP and other regulatory agencies.
Capable of training Chemists.
Able to transfer methods between departments.
Infinity Laboratories is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.