Chemistry Analyst II

Position Summary:

Conduct analytical chemistry testing at varied complexities using various wet chemistry and instrumentation techniques with emphasis on chromatographic analyses for raw material, stability and finished good products to ensure product compliance and providing laboratory technical support product deadlines. Providing technical support and coaching to junior analysts and ensuring routine testing and release of pharmaceutical products is met. Provides support on instrument and method validation work. Supports sample submission, tracking and testing. Aid in performance of non-conformances and investigations that occur in the laboratory. Ensuring on the maintenance of a cGLP laboratory and keeping up with regulatory requirements.

Essential Functions:

• Produces analytical work with varied complexities in accordance with all applicable Standard Operating Procedures and approved analytical methods.


• Conducts routine laboratory analysis of pharmaceutical raw materials, bulk formulated products, and finished goods.


• Proficient in the use of analytical techniques and works independently to perform complex chemical and physical analyses on all products and materials, this includes pH, color and clarity, FTIR, UV-VIS, Accusizer, HPLC, USP monograph testing and use of software programs for analysis.


• Interprets and documents all test results, calculations, observations and completes report summaries.


• Utilization of Enterprise Resource Planning (ERP) for daily workflow.


• Utilization of a Quality Management System (QMS) for trainings and document review/ improvements


• Perform instrument maintenance and Troubleshoot equipment failures.


• Produces analytical reports, which are accurately documented and with procedural integrity for all work performed.


• Assists Laboratory Leads to complete instrument, method protocols and method development work for analytical testing and product validations.


• Recognizes non-conforming results and reports them promptly to Quality Control Management.


• Works with Quality Control Management or designees to complete Laboratory Investigation Reports CAPA Investigations, Issue Reviews, Deviations and Nonconformances.


• Works as an effective team member to meet departmental objectives, sharing knowledge with the team members and across the laboratory.


• Helps train new and junior analysts to receive appropriate training and information necessary to conduct their activities in a safe and professional manner.


• Provides technical troubleshooting support, knowledge transfer and training/coaching to the other junior analysts.


• Promotes and maintains a safe, healthy working environment and work area by instructing and enforcing compliance with established safe work practices and procedures.


• Practices Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) in a pharmaceutical laboratory environment.


• Performs general maintenance and calibration of laboratory equipment, works with vendors, and ensures lab efficiencies and organization are maintained.


• Responsible for disposing of any waste in a safe manner and maintains cleanliness of the lab.


• Assists QC management in writing and revising department policies and procedures.


• May perform other duties as assigned.

Education and Experience:

• A Masters Degree in an applicable scientific field with 1 year experience

OR

• A Bachelor’s degree in an applicable scientific field with a minimum of 2 to 3 year relevant experience.

OR

• An Associates degree in a scientific field with a minimum of 3 to 4 year relevant experience.

OR

• May consider candidate with a high school diploma with minimum of 5 to 8 years relevant experience.


• Proficient in the use of analytical techniques.


• Prior experience with HPLC and GC, preferred.


• Experience working with Microsoft excel, Access and Word.


• Experience using a Laboratory Management system.


• Experience with cGMP 21CFR 11/210/211/820 Quality systems


• Experience with United States Pharmacopeia (USP), preferred.


• Investigational writing and risk assessment experience, preferred.

Knowledge, Skills and Abilities:

• Strong attention to detail with the ability to follow standard operating procedures.


• Able to adapt and respond quickly in a fast-paced environment.


• Ability to work independently to perform routine chemical and physical analyses.


• Able to communicate in a professional manner and interact with management, clients, and vendors on routine basis.


• Excellent organizational, verbal, and written communication skills.

• Must be organized and flexible with an ability to handle multiple work assignments.


• Required basic laboratory skills and techniques including pipetting, solution and sample preparation, weighing, etc.