QC Chemist

Job Description

Department: Quality Control

Job Title: Chemist I

Reports To: Manager of Quality Control

1. Role Purpose:

The Quality Control (QC) Chemist I will be responsible to perform routine testing of incoming raw materials, packaging components, drug substances, in process samples, drug products, and stability samples in accordance with internal Methods of Analysis (MOA), compendial, and other test methods. Adherence to Standard Operating Procedures (SOP) and the United States Pharmacopoeia (USP) is required. Analytical techniques will include bulk/tapped density, pH, KF, titrations, dissolution, UV-VIS spectrophotometry, and other ancillary test methods, HPLC and other, as necessary.

Attributable, legible, contemporaneous, original, and accurate documentation is also required

Work also needs to be completed in accordance with applicable FDA, OSHA, EPA, and DEA requirements.

2. Key Duties & Responsibilities:

Performing routine analytical analysis of raw materials, packaging components, drug substances and drug products using different compendial and KVK Tech test procedures in compliance with written, approved methods

Ensuring all instruments are calibrated before each use

Documenting all performed analysis using cGMP, USFDA and 21CFR211.194 guidelines.

Maintaining laboratory records including notebooks, logs, and other pertinent documentation

Following current Good Manufacturing Practices (cGMP), applicable Code of Federal Regulations (CFR)

Reviewing data for compliance to procedures and specifications

Completing all training prior to performing GMP activities

Adhering to the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA) safety regulations.

Operating and calibrating, or performing Preventive Maintenance and routine trouble shooting on analytical instruments

Complying with FDA guidelines/Company Policies of Data Integrity

Working independently under general supervision and direction in compliance with cGMP

Performing other duties as assigned or delegated

Handling hazardous waste in compliance with company SOP and hazardous waste rules

3. Typical Supervisory Responsibility:

N/A

4. Education & Experience:

BS in Chemistry or related science field preferred

5. Technical competencies/ Certifications/ Licenses:

· Working knowledge of HPLC, UPLC, GC, Dissolution, AA, UV spectrophotometers, pH and titration equipment

· Aptitude for application of analytical methods

· Skilled in laboratory techniques

· Good verbal and written English

· Excellent interpersonal and communication skills

Certifications

N/A

Licenses

N/A

Other

N/A

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/