QC Scientist III FM BSD

Your Responsibilities

The Quality Control Scientist III function is to perform laboratory day-today operations, guide and

interact with QC and department personnel to accomplish goals and objectives as directed by the

Director of Quality Control. Other duties include performing in-process testing, GC method validation,

raw material testing, and final product testing, QC documentation and related GMP activities.



Your Tasks

• Maintain and perform daily operations of the QC department on a daily basis in coordination with the QC Director to include testing of in-process, raw material/peptide samples and prioritizing projects
• 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
• Maintain a cGMP quality level of work for the QC operations to include training, documentation and procedural work
• Test and release in-process, and raw materials used in the manufacturing facility for GMP. Performing analytical testing and reviewing data for completeness and accuracy. Support method validation activities for in-process samples.
• Receive, test and release final product peptide manufactured at Bachem
• Write/revise specifications as necessary, performing analytical testing and reviewing data for completeness and accuracy
• Write standard operating procedures, standard test procedures and other related GMP documentation
• Perform QC analysis to include: GC, HPLC, Water, Mass Spec, UV, 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 testing activities as needed, documentation and quality GMP procedures

Your Profile

• BS Degree in Chemistry or related field
• Minimum of 8 years' experience in the GMP industry
• Experience with the use of analytical techniques/ instruments, such as, Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), Karl Fischer (KF), etc.
• May work with hazardous materials and chemicals
• Ability to train others in analytical methodology
• Ability to take the technical lead working with other scientists
• 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
• May involve second shift testing activities
• Flexibility of working hours based on business needs, may include some nights and occasional weekends

Preferred:

• Experience with Peptides
• Master's degree in Chemistry or related field
• Experience with use of Master Control

We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are

l looking for a new challenge and want to join a motivated team in an internationally renowned company,

you should seize this opportunity.

Nearest Major Market: San Diego