Chemist I, Drug Product Laboratory

Description:

JOB DESCRIPTION

Job Title: Chemist I, Drug Product Laboratory

Reports To: QC Laboratory Manager

Department: Quality Control

Summary:

Under the direction of QC Laboratory management, Chemist I is an entry-level professional role focused on acquiring foundational laboratory skills and experience. The individual learns to perform routine analytical testing of pharmaceutical products in accordance with site policies, departmental procedures, compendial methods, and cGMP regulations. Participates in programs to achieve departmental objectives, records and reports results, and notifies management of unusual results for evaluation.

Essential Duties and Responsibilities:

The essential functions of this position may include, but are not limited to:

1. Learning to perform routine analytical testing of in-process, finished product, and stability samples following approved specifications and Standard Operating Procedures (SOPs). This may include but is not limited to moisture testing, pH testing, Content Uniformity testing, the use of HPLCs, and other wet chemistry testing.
2. Perform USP Compendial testing and other Compendial testing as required.
3. Acquires proficiency in wet chemistry testing, Empower chromatography software, LIMS software, and general laboratory skills.
4. Completes testing with a high degree of efficiency, reliability, and accuracy.
5. Learns to maintain the QC Laboratory, including daily calibration of standard equipment, and audit readiness.
6. Records and reports test data correctly and accurately within company guidelines.
7. Performs assigned work in a timely and safe manner, conforming to regulatory, company, and compendial requirements.
8. Actively assumes responsibility in learning and adhering to sit standard SOPs and federal regulations.
9. Acquires knowledge of company and departmental policies pertaining to cGMP, cGLP, safety, health, security, and departmental operation. Complies with company and departmental regulations, policies and guidelines while performing duties of the job.
10. Recognizes problems within the scope of the job and promptly communicates them to management.
11. Performs other duties as required.

Knowledge Necessary to Perform the Job:

1. Basic understanding of quality control principles and chemistry.
2. Ability to effectively communicate status of testing to management.

Competency:

To perform the job successfully, an individual should demonstrate the following competencies:

Analytical:

Collects and evaluates data; analyzes information skillfully by applying good scientific judgement; maintains accurate / concise records with attention to detail.

Technical Skills:

Ability to operate analytical balance, computer, HPLC, pH meter, Karl Fischer, Specific Gravity, and other modern analytical equipment. If skills need developed, work with trainers and management to develop and maintain those skills.

Oral/Written Communication:

Listens carefully and gets clarification where needed. Able to express complex ideas in a clear, concise manner. Capable of explaining technical issues to non-technical personnel. Completes documents / logs clearly and accurately.

Ethics/Professionalism:

Works with integrity and ethically maintains confidentiality. Projects a professional and courteous business demeanor.

Organizational Support:

Supports organization’s goals and values. Follows policies and procedures.

Adaptability:

Ability to deal with frequent changes to schedules, delays, or unexpected events.

Attendance/Punctuality:

Maintains regular and punctual attendance.

Initiative:

Meets challenges with resourcefulness. Proactively identifies and resoles issues which have the potential to affect analytical operations or schedules.

Quality:

Produces analytical work of high quality. Observes company quality policies and procedures.

Safety and Security:

Observes safety and security procedures. Responsible for meeting department safety objectives and follow on-going safe operating procedures consistent with the job requirements.

Requirements:

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or abilities required of the position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:

Bachelor’s degree in Chemistry or a related scientific field. 0-2 years of prior laboratory or relevant professional experience is preferred but not required. An equivalent combination of education, training, performance, and experience may be considered.

Language Ability:

Ability to read and understand applicable compendial methods, SOPs, general business periodicals, professional journals, technical procedures, and/or government regulations.

Math Ability:

Ability to add, subtract, multiply, and divide in all units of measure using whole numbers, common fractions, and decimals.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions; interpret an extensive variety of technical instruction in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

To perform this job successfully, an individual should have basic computer skills with knowledge of Word, Excel, Access, Outlook and ability to use internet tools.

Work Environment and Physical Demands:

The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in this work environment is usually moderate. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts and working with general laboratory chemicals with proper safety equipment. The employee is occasionally required to stand, walk, sit; use fingers to handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include ability to adjust focus and ability to distinguish colors.