2nd shift-Chemist, QC

Job Overview:

Under minimal supervision of QC management, the QC Chemist performs physical and chemical testing on raw materials, in-process and finished products, as well as stability samples.  Utilizes established methods and standard operating procedures and laboratory equipment to perform testing of materials.  Prepares high quality written documentation, such as notebooks, logbooks, standard operating procedures (SOPs) and LIMS reports.  Trouble shoots analytical equipment.  Provides training on analytical methods and new technologies.

Responsibilities:

• Performs analytical testing of raw materials, in-process materials, finished products and stability samples.
• Operates laboratory equipment such as balances, pH meters, hardness testers, particle size analysis, LOD, Karl Fischer, Melting Point, etc. in accordance with laboratory SOPs and test methods.
• Effectively performs routine testing using HPLCs, GCs, UV-VIS, FT-IR and ICP-MS equipment in accordance with SOPs and test methods.
• Performs data analysis and evaluation of test results.
• Prepares reports and reviews data.
• Maintains accurate records of test data, maintains laboratory notebooks and logbooks in accordance with company guidelines and GDPs.
• Assists in writing and revising SOPs and tests methods as needed.
• Follows documented procedures: SOPs, test methods, and transfer protocols.
• Performs routine maintenance, calibration, and performance verification on applicable instruments.
• Performs investigation activities and writes deviation and investigation reports.
• Suggests and writes CAPAs.
• Follows lab safety procedures. 
• Perform other duties as assigned.

Qualifications: 

• Bachelors in chemistry or related physical/biological science, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Minimum of 3 years’ experience in Pharmaceutical Analysis 
• Must understand analytical chemistry.
• Demonstrated knowledge of cGMP regulations and ICH guidelines 
• Computer literacy and ability to use data acquisition and processing software, such as EMPOWER 3
• Demonstrate the ability to read, analyze, and interpret USP/NF methods, SOPs and technical procedures manuals, and batch records.
• Demonstrate the ability to define problems, collect data, establish facts, and draw valid conclusions; interpret an extensive variety of technical instruction in mathematical or diagram form.
• Knowledge of basic laboratory practices, methods, and techniques
• Demonstrate the ability to carry out work assignments communicated orally or in writing.
• Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrate the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate solid understanding of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

Physical Demands: 

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).