Job Overview:

Under supervision of QC management, the Associate 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.

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 and performance verification on applicable instruments.

• Assists in deviation and investigation activities.

• Follows lab safety procedures.

• Performs other tasks, as assigned.

Qualifications:

• Bachelors in chemistry or related physical/biological science, or equivalent experience.

• 0-2 years’ experience in Pharmaceutical Analysis

• Must understand analytical chemistry.

• Computer literacy and ability to use data acquisition and processing software, such as EMPOWER 3

• Knowledge of cGMP regulations and ICH guidelines

• Ability to read, analyze, and interpret USP/NF methods, SOPs and technical procedures manuals, and batch records.

• Carry out work assignments communicated orally or in writing.

• Health and Safety Awareness

• Demonstrates excellent personal organizational skills.

• Demonstrates effective multi-tasking.

• Knowledge / Experience with electronic Quality Management Systems such as MasterControl

• Knowledge of current federal, local, and international regulations regarding the production, testing and release of drug substances and products.

• Familiarity with Microsoft programs, such as Word, Excel, PowerPoint, Access, Project, etc.

• Ability to always portray an appropriate level of integrity and professionalism.

• Ability to communicate effectively with management, staff, regulators, and client representatives, in both written and verbal forms.

• Ability to complete tasks accurately and according to established timelines.

• Ability to make sound decisions about scheduling, allocation of resources and managing priorities.

• Energetic, self-motivated, 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.

• Ability to work closely with a diverse customer and employee base (internally and externally).

• 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).

All job requirements in the job description provided indicate the level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.

I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodations.