The major responsibility of the Quality Control Chemist is to perform physical and chemical testing on raw materials, packaging component, in-process, finished products, stability samples, cleaning verification, cleaning validation, process validation following Analytical Methods, Protocols, Procedures (SOPs) and company policies. He/she follows and maintains adherence to current industry standards (cGMPs, GLPs, etc.) to meet production and customer demand. Qualified candidates will be expected to work either independently or as a team to achieve company goals and initiatives. The Quality Control Chemist will report to the Quality Control Laboratory Group Lead and efficiently conduct all duties and responsibilities assigned and or delegated by the Head of Quality Control, Laboratory Manager or the Site Head of Quality.

Essential Duties and Responsibilities:

• Perform analytical testing of raw materials, in-process, finished product and/or stability samples, cleaning verification, cleaning validation, and process validation following Analytical Methods, Protocols, Procedures (SOPs) and company policies
• Testing includes, assay, related substance, dissolution, residual solvents, viscosity, pH, Water content, Specific Gravity and other tests according to the analytical methods, USP, procedures in a regulated laboratory environment
• Analyze samples using appropriate instrumentation such as HPLC, UPLC, GC, Dissolution apparatus, UV, IR, Karl Fisher (KF), pH, Viscometer etc.
• Perform instrument calibration such as HPLC, UPLC, GC, Dissolution apparatus, UV, IR, Karl Fisher (KF), pH, Viscometer etc.
• Maintain data within a laboratory notebook in a legible, organized, and compliant manner, and transcribes or enters data into necessary records in an accurate and timely manner
• Process and report the analysis results using the instrument specific data processing software
• Reviews generated data in a timely manner and elevates any Non-Conformance, Out of Specification, or other Deviation to Laboratory Management promptly for further investigation
• Performs investigative testing or other functions to assist with laboratory investigations
• Follow all SOPs, Safety Guidelines and good housekeeping practices to ensure compliance with cGMP and Housekeeping requirements
• Identify and troubleshoot problems with instrumentation and analytical preparations
• Maintain lab work area in a neat and orderly fashion
• Assists in execution of training and acts as a mentor to less-experienced analysts
• Works in support of production and development projects and may require weekend, off-shift work, or overtime as necessary to complete high priority work assignments
• Works with computers as well as laboratory software, or proprietary software as needed
• Other duties may be assigned

ADDITIONAL RESPONSIBILITIES:

• Responsibilities for the appropriate documentation and disposal of unused laboratory samples and expired reagents
• Maintain and demonstrate a high level of personal and professional integrity and Report any suspicious activity to laboratory management
• Assists Laboratory Management on special projects and assignments
• Additional responsibilities may be assigned by Laboratory Management as needed

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential Duty satisfactorily. The requirements listed are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Safety Requirements:

• Ensure adherence to all personal protective equipment
• Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources

Competencies/Skills:

• Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.
• Strong organizational skills and the ability to multitask
• Demonstrated ability in working independently and as part of a team
• Must be able to work in a cross-functional environment interacting with other internal departments and external vendors
• Excellent communication (oral and written) and interpersonal skills
• Ability to meet attendance standards. All full-time employees are required to work a 40-hour week. At times it may be necessary to work additional hours in order to accomplish the required tasks to meet deadlines.
• Must have a teamwork attitude

Education and/or Experience:

• Minimum B.S. Degree in Science Field Chemistry Degree Preferred.
• 1 or more years of experience in an analytical laboratory in pharmaceutical or related field of analytical chemistry
• Experience in testing raw materials, in-process, finished products and/or stability samples such as assay, related substance, dissolution, residual solvents, viscosity, pH, Water content, Specific Gravity and related testing in an FDA regulated laboratory environment required
• Basic understanding of cGMPs and compendia procedures where applicable (i.e., USP, NF, BP, etc.) required
• Excellent communication (oral and written) and interpersonal skills
• Demonstrated technical expertise in laboratory instruments, i.e. HPLC, UPLC, GC, UV, Karl Fisher.
• Experience in instrument calibration i.e. HPLC, UPLC, GC, Dissolution apparatus, UV, IR preferred
• Experience with Empower or related lab software preferred
• Prior experience in a pharmaceutical (cGMP) laboratories setting is required

Language Skills:

• Ability to read and comprehend instructions in the English language through verbal and written methods.
• Ability to write or speak in the English language and communicate information effectively in one-on-one and in a group of employees within the organization.

Mathematical Skills:

• Ability to interpret data utilizing intermediate math operations; perform complicated analytical calculations and statistical analysis

Reasoning Ability:

• Ability to apply common sense understanding to carry out multi-step instructions
• Deal with standardized situations with occasional variables

Physical Demands:

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear.
• Frequently lift and/or move up to 25 pounds.
• Specific vision abilities required by this job may include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Physical Demands:

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear.
• Frequently lift and/or move up to 25 pounds.
• Specific vision abilities required by this job may include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment:

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Noise level in the work environment is usually moderate but may be loud at times