Scientist I, Quality Control, Compendial

About this opportunity :

In this role you will support the daily operations of the Quality Control Department by performing, often complex, compendial testing of raw materials and container closure systems in accordance with cGMP requirements, company policies and procedures as directed by laboratory management.

Responsibilities: 

• Perform, often complex, laboratory analysis of raw material and container closure system samples according to established specifications and procedures using analytical chemistry techniques in accordance with Customer, Company, and cGMP requirements.
• Read and understand test methodologies, study protocols, and Standard Operating Procedures in order to review or execute testing in compliance with necessary policies and procedures. Record/review data in controlled notebooks, data sheets, and electronic systems (i.e. LIMS, etc.) in accordance with cGMP requirements.
• Work on problems ranging from moderately complex to complex in nature where analysis of situations or data requires in-depth review and evaluation of various factors, considerable judgment is required in resolving problems and making routine recommendations. Exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Notify Supervisor of any discrepancy in laboratory testing or general laboratory operations. In case of any observed discrepancies, initiate and follow through with the required quality exception documentation as needed.
• Assume ownership of assigned quality documentation, such as investigations, change controls, and CAPAs, ensuring that documentation is initiated and closed on time, required actions are thorough and meet procedural requirements as well as customer needs.
• Recommend equipment, facility, and process improvements to your supervisor.
• Maintain clear, accurate and traceable documentation records to ensure compliance with Good Documentation Practices (GDP).
• Maintain laboratory and workspace cleanliness by adhering to the 5S method of organization.
• Abide by safe work practices and adhere to general safety rules, performing all duties in a safe manner and never placing yourself or those around you in an unsafe condition. Report all unsafe conditions to your supervisor.

Qualifications:

• A minimum of 4 years, 6+ years preferred, industry related work experience. 
• Bachelor's degree or equivalent in scientific discipline required. Advanced degree preferred.
• Proficient with the ICH requirements for method verification, transfer, qualification, and validation.
• Proficient with USP, Pharm. Eur. and other compendial methods and procedures.
• Advanced knowledge of analytical chemistry principles and techniques using various laboratory apparatus and instrumentation (i.e. UV/Visible Spectrophotometer, Fourier transform infrared (FTIR) spectrometer, total organic carbon (TOC) analyzer, pH meter, Karl Fischer Titrator, Extraction/Separation chemistry, Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS) and Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES), etc.).
• Able to use LIMS and electronic documentation systems (i.e. SmartSolve).
• Proficient in root cause analysis and technical investigation writing and review.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project, etc.)

The starting salary range for this position is between $85,000 and $92,000 annually.