QC Chemist

Job Description

Job Description

Title : Analytical Chemist 1 QC

Location : Whippany, NJ 07981

Duration : 6 Months

Shift : 8 AM to 5 PM

POSITION SUMMARY

The Analytical Chemist will analyze raw material, in-process, finished products and stability samples assuring compliance with standard operating procedures, Compendia sources, Test methods and Protocols.

ESSENTIAL FUNCTIONS

1.                   With supervision, conducts Routine and non-routine activities. Performs analytical testing of raw materials, in-process control materials, stability samples, and finished product (Commercial, Clinical and Registration Batches) using different analytical techniques.

2.                   Diligently follow written laboratory protocols, guidelines, procedures and methods.

3.                   Expected to utilize established scientific techniques to compile and analyze data.

4.                   Ensure that products are being tested strictly under cGMP conditions and disposition is taken on time as per the committed production plan for every month.

5.                   Ability to identify creative and innovative solutions of non-routine analytical tasks.

6.                   Suggests improvements of laboratory testing procedures, techniques and / or instrumentation

7.                   Performs other duties related to the position when required by laboratory management

8.                   Proficient in the use of Empower

9.                   Exposure to the basic theory and operating principles of HPLC, UV, FTIR, GC, and Malvern particle size analyzers.

10.                Other duties as assigned.

POSITION QUALIFICATIONS

1.                   Ability to independently prioritize workload.

2.                   May work on multiple projects and group to ensure the desired outcome is timely.

3.                   Consults with supervisor / management on decisions for all the issues.

4.                   Recognizes problems or compliance issues and reports to management.

5.                   Good written and oral communication skills. Proficient in the ability to read / write and comprehend complex instructions, correspondence, and memos.

6.                   Experience in chromatography (e.g. HPLC with Empower data acquisition software, GC, FTIR, UV and wet chemistry)

7.                   Knowledge of ICH, FDA, and DEA regulations.

8.                   Demonstrate computer literacy with proficiency in Microsoft office software, Trackwise and Empower.

9.                   Must be able to move about the facility

10.                Must be able to wear personal protective equipment

11.                Must be able to lift up to 25 lbs

EDUCATION

1.            A BS in Chemistry degree is required

EXPERIENCE

1.                   2 years working in pharmaceutical manufacturing environment.

2.                   Solid understanding of cGMP practices and concepts.

Company Description

We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.

Company Description

We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.