QC Scientist II

Your Responsibilities

The QC Scientist II performs laboratory day-today operations, guides and interacts with QC and

department personnel to accomplish goals and objectives as directed by supervisor.Other duties

include performing raw material testing, final product testing, QC documentation and related GMP?

Your Tasks

Maintain and perform daily operations of the QC on a daily basis in coordination with the QC Director / Supervisor to include testing of raw material / peptide samples and prioritizing projects

Write and work with other QC Staff and other Department in the creation and approval of control documents such as specifications, SOPs, STMs, etc.

Maintain and perform regular verification of the QC equipment for GMP compliance regularly in coordination with QC Director / Supervisor

Implement and maintain GMP procedures such as following SOP’s, Standard Testing Procedures (STP’s), written procedure and maintaining proper documentation as necessary for Quality Control

Test, review, and release raw material used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy

Receive, test and release final product peptide manufactured at Bachem

Test and release in-process control samples used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy

Maintain a cGMP quality level of work for the QC operations to include training, documentation and procedural work

Write / revise specifications as necessary, performing analytical analysis and reviewing data for completeness and accuracy

Write standard operating procedures, standard test procedures and other related GMP documentation

Implement and maintain GMP procedures such as following written procedure and maintaining proper documentation as necessary for Quality Control

Perform QC analysis to include : HPLC, UPLC, Water, Mass Spec, UV, GC, melting point, Optical Rotation, TLC and misc. wet chemistry lab work and other related analytical equipment used for control quality of the GMP facility.

This work may include calibration and validation of these methods

Control raw material used in the manufacturing facility for GMP to include receiving, quarantine, testing and QC release

Investigate any deviation or out of specification as necessary related to QC work performed as instructed by supervisor

Execute validations as necessary to include QC Analytical methods performed, other validations to support the quality of the manufacturing facility

Follow safety guidelines for handling, disposal and use for a peptide manufacturing company using toxic and / or large volumes of chemicals

Support validation, and stability as necessary to include but not limited to analytical work, documentation and quality GMP procedures

Your Profile

Bachelor’s Degree in Chemistry or related field

Minimum of 5 years’ experience in the GMP industry

Use of analytical techniques / instruments, such as, HPLC, GC, etc. and computer skills

Excellent written and oral communication skills

Basic computer knowledge, including Microsoft Word, Excel and PowerPoint

Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment

Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues

Detail oriented with the ability to troubleshoot and resolve problems

Ability to work independently and manage one’s time

Communicate effectively and ability to function well in a team environment

Ability to review Certificate of Analysis for Reagents for the creation of specification documents

Organization skills to support the department in the creation and approval of controlled documents in a timely manner

Flexibility of working hours based on business needs, may include some nights and occasional weekends

Preferred :

Experience with Peptides

Technical writing experience

Master’s degree in Chemistry or related field

Experience with Equipment Maintenance Programs