Quality Control Scientist

Temecula, CA, USA|Onsite

Job Overview

Employment Type

Full-time

Hourly

Compensation

Hourly

Range $30.01 - $41.27

Work Schedule

Flexible

Weekend Shifts

Night Shifts

Benefits

competitive pay

Annual performance bonus

Medical Coverage

dental coverage

vision coverage

401(k) plan with employer contribution

Paid vacation, personal and sick days

Job Description

Bachem Americas is a leading company specializing in the manufacture and supply of peptides and complex organic compounds for the pharmaceutical and biotechnology industries. With a strong commitment to quality, innovation, and sustainability, Bachem provides high-quality products and services that support research and production processes worldwide. The company prioritizes environmental responsibility, holding a Gold Medal status from EcoVadis for its ecological performance and offers a comprehensive total rewards package to its employees, including competitive compensation, benefits, and opportunities for career advancement. Bachem Americas fosters an inclusive and diverse work environment where all individuals are valued and provided equal employment opportunities regardless of race, gender, or other protected statuses.

The Quality Control Scientist role at Bachem Americas is integral to maintaining the high-quality standards that the company is known for in the pharmaceutical and biotech sectors. This is a dynamic position that involves overseeing daily laboratory operations related to quality control, performing precise raw material and final product testing, and ensuring compliance with Good Manufacturing Practices (GMP). The scientist will work closely with QC department personnel and other teams across the organization to meet quality objectives and uphold regulatory standards.

The position requires meticulous attention to detail and strong analytical skills to carry out a variety of testing procedures that ensure the purity and quality of peptide samples and materials used in manufacturing. Responsibilities include the development and approval of critical quality control documents such as specifications, standard operating procedures (SOPs), and standard testing methods (STMs). The Quality Control Scientist is also tasked with regularly verifying QC equipment to guarantee GMP compliance, managing documentation accurately, and investigating any deviations or discrepancies arising during testing processes.

Candidates in this role will use an array of advanced analytical techniques, including HPLC, UPLC, GC, Mass Spectrometry, UV spectroscopy, and more, to perform thorough chemical analyses. The role demands experience with equipment maintenance programs and validation procedures, including method validation and stability studies, to ensure operational effectiveness and compliance. Strong communication and organizational skills are essential for collaborating with team members, documenting data, and supporting continuous improvements in QC operations.

Bachem Americas offers tiered compensation ranges depending on the level of experience and qualifications, with hourly rates for Scientist I starting at $30.01 and progressing up to Senior Scientist roles at $66.11 per hour. This comprehensive role provides opportunities to work in a fast-paced, innovative environment where quality control is pivotal to the company's success. Moreover, flexibility in working hours, including occasional nights and weekends, may be required to meet business needs.

Overall, this position presents a challenging and rewarding opportunity for those with a background in chemistry or related fields, a passion for quality assurance in pharmaceutical manufacturing, and a commitment to maintaining the highest standards of GMP compliance. Working at Bachem Americas means contributing to projects that have a global impact on health and wellness, while also being part of a socially responsible and forward-thinking organization committed to environmental stewardship and employee development.

Job Requirements

Bachelor's degree in chemistry or related field
Minimum of 1 year experience in GMP pharma/biotech facility
Ability to work independently and manage time effectively
Strong organizational and multitasking skills
Excellent written and oral communication skills
Familiarity with analytical instruments such as HPLC, GC, Mass Spectrometry
Understanding of GMP regulations and compliance requirements
Ability to follow safety guidelines and protocols
Flexibility to work nights and weekends as needed

Job Qualifications

Bachelor's degree in chemistry or related field
Master's degree in chemistry or related field (preferred)
Minimum of 1 year experience in GMP pharma/biotech facility
Experience with Equipment Maintenance Programs
Experience with the use of analytical techniques/instruments such as Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), Karl Fischer (KF), etc.
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

Job Duties

Maintain and perform daily operations 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
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, including 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 procedure