Chemist

Chemist

*Please note on application which shift/s you'd be available to work*

The position is responsible for testing Cleaning, Raw Material Water, In-Process and Finished Product samples as well as Chemistry Documentation review. Leads the support for validation projects and coordinating methods validation/verification/transfer from customers. Supports new NPD project activities. Audit and review analytical testing, reagent preparation, instrument calibration and validation testing performed in the Chemistry Laboratory. 

·        Completely, accurately and precisely prepares all laboratory reports and/or test scripts and documents in accordance with cGDP and cGMP requirements

·        Author and perform method validation/verification/transfer and instrument validation protocols.

·        Write standard operating procedures for new equipment and/or processes. 

·        Coordinate testing with Validation and NPD to provide chemical testing support.

·        Review and approve Documentation for the release of product.  Review Standard Operating Procedure revisions and report forms to increase efficiency of chemists and maintain cGMP and GLP’s. 

·        Guide and author Chemistry Out of Specification (OOS) investigations and non-routine events.  Investigate for the root cause of the OOS.  Help to maintain a cGMP laboratory.

·        Audit and review all laboratory and chemist procedures and work product including:  In- process, cleaning samples, finished product, raw material and water testing; notebook, validation and expiration studies; reagent and standard preparation and instrument usage logs.

·        Assist with and conduct studies as requested by the Lab Supervisor/Manager

·        Work independently and make quality decisions based on SOP requirements with minimal supervision.

·        Complete tasks as required (in a timely manner), compliant with cGMP, regulatory and corporate requirements and conform to Health, Safety & Environmental responsibilities. 

·        Documents all work to cGMP and corporate standards with few errors.

·        Proficient and regular data reviewer for analyses following written procedures and is capable of reviewing data for projects not based on written procedures like cleaning verification method development or validation.

·        Demonstrates multi-tasking ability and the ability to prioritize the work for multiple projects or materials on a weekly basis.

·        Coordinates and performs assigned projects and is capable of organizing and leading projects involving several parts or several associates.

·        Compares data to specifications, recognizes and reports (to supervisor) atypical data and demonstrates the ability to observe and communicate trends in data and develop/contribute to “continuous improvement” plans.  Acts on data trends with limited supervisory review.

·        Proficient in multiple laboratory techniques and demonstrates an in-depth understanding of one or more core laboratory techniques such as HPLC. The individual will perform these techniques on a routine basis.

·        Demonstrates analytical problem solving skills including troubleshooting laboratory and instrumental problems with little supervision.  Demonstrates high levels of initiative and thinking to resolve problems.  Able to resolve problems which require some independent judgment.  Proactive in taking appropriate action to resolve routine problems and helps other staff take appropriate action.

·        Demonstrates high ethical standards

·        Evaluates and implements new analytical technology of strategic.

·        Other duties as assigned.

top requirements:

1)      Perform analytical testing and calculations on raw materials, in-process bulk material, finished product and cleaning samples.

2)      Experience with various analytical instruments, such as HPLC, UV/Vis, Balances, Densitometer, Autotitrator, pH meter, Conductivity Meter, Total Organic Carbon Analyzer (TOC), Osmometer, Viscometer, Karl Fischer, Particle Counter and Polarimeter in a Quality Control Lab setting.

3)      Prepare test reports and perform cGMP documentation and peer review of documentation.

4)      Write and revise test methods and SOPs.

5)      Knowledgeable with analytical test method transfer/verification/validation and can author protocols and summary reports.

Education or Equivalent:

 

·        Bachelor of Science in Chemistry or Sciences or equivalent

 

Experience: 

 

·         3+ years’ experience in a cGMP and/or pharmaceutical manufacturing environment

 

Knowledge/Skills Requirements:  

 

·        Perform analytical testing and calculations on in-process bulk material, finished product, cleaning and customer samples.

·        HPLC, UV/Vis, Balances, Densitometer, Autotitrator, pH meter, Conductivity Meter, Total Organic Carbon Analyzer (TOC), Osmometer, Viscometer, Karl Fischer, Particle Counter, Malvern, Polarimeter, Microscope.

·        High level of attention to detail.

·        Excellent documentation skills.

·        A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.).

·        Strong problem solving and analytical skills.

·        Ability to work independently on multiple projects.

·        Works well in a team environment.

·        Possess and demonstrate excellent verbal, written and interpersonal communications skills.

·        Works well under pressure and able to prioritize workloads with little or no supervision.

·        Must be able to interact effectively with a variety of individuals and personalities within and between departments.

·        Perform independent work related to projects and/or routine activities.

·        Must be proactive and willing to take initiative and responsibility.

·        Should be familiar with cGMP and safe work practices.

·        Demonstrated ability to read, write, and speak clear English