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- Complying with FDA guidelines/Company Policies of Data Integrity
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QC Chemist - Newtown, United States - KVK Tech
Description
Job Description
Job DescriptionDepartment: 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:
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/A