Summary / Objective
The primary function of a QC Chemist I is to perform qualitative and quantitative chemical and physical analyses at a high level in support of one of the following areas:
· Analysis of raw materials and packaging components
· Analysis of in-process and finished drug products, including stability testing, for primarily high-volume products
Essential Functions
· Follows test methods and completes testing with supervision as needed.
· Learns and applies USP concepts for laboratory testing.
· Develops oral and written communication skills.
· Follows Good Documentation Practices (GDP) for all documentation.
· Demonstrates basic laboratory skills and a foundational understanding of chemical testing equipment and processes.
· Learns and follows basic cGMP (current Good Manufacturing Practices), DEA (Drug Enforcement Administration) regulations, and quality procedures for working in a QC laboratory.
· Compiles results as directed and understands basic concepts related to the evaluation of analytical data and data integrity.
· Identifies basic technical problems and seeks assistance when needed.
· Uses sound scientific principles and demonstrates a basic understanding of laboratory instruments and equipment.
· Specialized
o Technical Support: Performs testing with supervision as needed.
o Instrumentation: Assists with cleanup and maintenance.
o Documentation Review: Understands GDP and 2PV requirements.
· Accountability
o Budget: Orders materials as needed with supervision.
o Self and Group Development: Recognizes deficiencies in foundational areas and pursues self-improvement.
o Documentation: Documents activities in procedures and laboratory notebooks with supervision.
o Ethics: Demonstrates declarative and procedural knowledge of data integrity and ethics.
· Supervision
o Works under direct supervision.
o Does not supervise others.
Skill Set Expectations
· Intermediate Excel skills preferred but not required
· Professional demeanor
· Reliable and dependable
· Organized and detail-oriented
· Highly accurate and efficient
· Exercises confidentiality
· Strong communication skills
Preferred Education and Experience
· Associate degree in Chemistry with 2–4 years of experience
· Bachelor’s degree in a related scientific field with 1–2 years of experience
· B.A. or B.S. in Chemistry
· Ability to stay current with relevant technology
Work Environment
This role operates in a professional laboratory and office environment, and business casual or casual attire is required. The role requires the use of standard office equipment such as computers, phones, and photocopiers. The employee is occasionally exposed to toxic and/or caustic chemicals such as sodium hydroxide, hydrochloric acid, acetonitrile, methanol, and other chemical solutions necessary in analytical chemistry. As a result, the employee may be required to wear a respirator or appropriate personal protective equipment (PPE) for certain laboratory tasks to ensure safety and protection. If a respirator is required, it will be provided by the company at no expense to the employee. In addition, any medical expenses for respirator fit testing will be covered by the employer.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must regularly lift and/or move up to 50 pounds. Specific vision abilities required for this position include close vision, color vision, and the ability to adjust focus. While performing the duties of this job, the employee is regularly required to stand, walk, sit, and talk or hear. The employee is occasionally required to climb or balance, stoop, kneel, crouch, crawl, and smell.
Position Type / Expected Hours of Work
Job Type: Full-time
Benefits:
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Health savings account
- Life insurance
- Referral program
- Vision insurance
Work Location: In person
