quality control specialist

Bayer AG; Berkeley (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Bayer AG in Berkeley seeks a seasoned Quality Control Chemistry professional to advance analytical capabilities and drive method development and validation in a regulated pharmaceutical setting.

You will operate modern instrumentation (HPLC/UPLC, KF titrator, polarimeter) and maintain rigorous documentation while collaborating with manufacturing, research, and quality units to ensure product quality and regulatory compliance.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field required.
• Master's degree or PhD in a relevant scientific discipline preferred.
• Minimum 6 years of experience in pharmaceutical or related industry with a Bachelor's degree, OR 2 years with Master's, OR PhD with relevant exposure.
• Minimum 3 years of experience in Quality Control laboratory operations.

Responsibilities

• Support the implementation and integration of new analytical methods within the Quality Control Chemistry department.
• Maintain comprehensive logs, notebooks, and electronic documentation systems in accordance with regulatory requirements.
• Conduct method feasibility studies and method development activities to support analytical testing needs.
• Execute laboratory assays for method validation protocols utilizing various chemistry instrumentation.
• Operate and maintain analytical equipment including HPLC, UPLC, KF Titrator, Autotitrator, Melting Point meter, Chloride meter, and Polarimeter.
• Troubleshoot assays and analytical instrumentation to ensure optimal method performance and data quality.
• Prepare samples using wet chemistry techniques and various analytical methodologies.
• Generate comprehensive method development reports and method validation reports.
• Follow established SOPs, pharmacopoeial guidelines, regulatory requirements, and safety protocols.
• Manage multiple concurrent tasks while working effectively with technical leads across different projects.
• Interface and collaborate with manufacturing, research, and other cross-functional teams.
• Utilize LIMS, SAP, and chromatographic software systems for data management and analysis.

Skills

HPLC

GMP

GDP

LIMS

SAP

EMPOWER

Method development

Validation protocols

Education

Bachelor's degree in Chemistry

Master's degree or PhD preferred

Tools

LIMS

SAP

EMPOWER chromatographic software

HPLC/UPLC instrumentation

Job description

Quality control

gmp

HPLC

Job Summary:

This position plays a vital role in advancing analytical capabilities within a dynamic Quality Control Chemistry environment. The successful candidate will be instrumental in implementing cutting-edge analytical methods while ensuring compliance with rigorous pharmaceutical standards. This role demands a detail-oriented professional who can seamlessly balance method development activities with validation protocol execution, all while maintaining meticulous documentation practices. The position requires expertise in operating sophisticated analytical instrumentation and the ability to troubleshoot complex technical challenges. Working collaboratively across multiple functions, this individual will contribute directly to ensuring product quality and regulatory compliance in a fast-paced pharmaceutical setting.

Responsibilities:

• Support the implementation and integration of new analytical methods within the Quality Control Chemistry department
• Maintain comprehensive logs, notebooks, and electronic documentation systems in accordance with regulatory requirements
• Conduct method feasibility studies and method development activities to support analytical testing needs
• Execute laboratory assays for method validation protocols utilizing various chemistry instrumentation
• Operate and maintain analytical equipment including HPLC, UPLC, KF Titrator, Autotitrator, Melting Point meter, Chloride meter, and Polarimeter
• Troubleshoot assays and analytical instrumentation to ensure optimal method performance and data quality
• Prepare samples using wet chemistry techniques and various analytical methodologies
• Generate comprehensive method development reports and method validation reports
• Follow established SOPs, pharmacopoeial guidelines, regulatory requirements, and safety protocols
• Manage multiple concurrent tasks while working effectively with technical leads across different projects
• Interface and collaborate with manufacturing, research, and other cross-functional teams
• Utilize LIMS, SAP, and chromatographic software systems for data management and analysis

Skills:

• Thorough knowledge of chromatography techniques including SEC, ION, NORMAL, REVERSE, and ION-PAIR chromatography
• Proficiency in electrophoresis methods including PAGE and agarose gel electrophoresis
• Expertise in simple chemistry methods such as spectrophotometry
• Strong understanding of biologics and pharmaceutical manufacturing processes
• Hands-on experience with LIMS, SAP, and EMPOWER chromatographic software
• Comprehensive knowledge of GDP and GMP practices
• Excellent documentation and technical writing abilities
• Strong analytical and troubleshooting capabilities
• Ability to manage multiple priorities and work independently
• Effective communication and interpersonal skills for cross-functional collaboration

Previous Experience:

• Minimum 6 years of experience in pharmaceutical or related industry with a Bachelor's degree, OR
• Minimum 2 years of experience with a Master's degree, OR
• PhD with relevant pharmaceutical industry exposure
• Minimum 3 years of experience in Quality Control laboratory operations
• Demonstrated hands-on experience with analytical instrumentation in a regulated environment

Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific field required
• Master's degree or PhD in a relevant scientific discipline preferred

This is an exceptional opportunity to join a forward-thinking organization where your analytical expertise will directly impact product quality and patient safety. You will work with state-of-the-art instrumentation and contribute to meaningful scientific advancements in a collaborative environment that values innovation and technical excellence. The role offers significant professional growth potential through exposure to diverse analytical challenges and the opportunity to work alongside experienced scientists in a regulated pharmaceutical setting.