Our client is looking to fill the role Quality Control Chemist. The Quality Control Chemist conducts intermediate to advanced-level physical and chemical analysis of raw materials, in-process samples, and finished products following established protocols. This role includes mentoring junior staff, performing complex cleaning validations, maintaining sophisticated instrumentation, and ensuring timely delivery of analytical results to meet project deadlines.
Responsibilities:
Advanced Technical Analysis
Execute complex testing procedures across all sample categories with expertise in multiple analytical methods and instrumentation platforms
Conduct advanced troubleshooting and preventive maintenance on laboratory equipment
Perform comprehensive physical and chemical analysis of materials throughout the manufacturing process to support product release decisions and process validation studies
Instrumentation & Data Management
Demonstrate mastery of analytical software platforms, including setup of complex testing sequences and advanced data reporting capabilities
Operate and maintain sophisticated instruments including UV spectrophotometers, FTIR, gas chromatography (GC), high-performance liquid chromatography (HPLC), and ion chromatography (IC) systems
Execute higher-complexity analytical methods requiring advanced instrument expertise
Cleaning Validation & GMP Compliance
Independently perform sampling and analysis of complex manufacturing equipment cleaning procedures in full compliance with current Good Manufacturing Practice (cGMP) standards
Contribute technical expertise to cleaning-related investigations and process improvements
Support regulatory compliance through rigorous adherence to documentation standards
Quality Systems & Investigations
Lead investigations of out-of-specification (OOS) results, trending anomalies, and process deviations according to regulatory guidelines
Collaborate with management on investigation documentation and product impact assessments
Mentor team members on laboratory investigation and OOS procedures
Method Development & Validation
Support analytical method validation studies and technology transfer initiatives
Author, review, and update laboratory testing procedures and standard operating protocols
Contribute to continuous improvement projects focused on cost reduction and process optimization
Training & Leadership
Provide technical training and guidance to chemists, laboratory assistants, and temporary personnel
Support customer and regulatory audit activities, particularly in areas of data integrity and instrumentation documentation
Conduct peer reviews and quality audits to ensure GMP compliance across laboratory operations
Documentation & Compliance
Maintain meticulous laboratory notebooks and documentation systems in accordance with cGMP standards and internal procedures
Perform systematic auditing of laboratory data and testing records
Demonstrate consistently reliable analytical performance with minimal need for repeat testing or investigations
Required Qualifications:
Education & Experience (Position level determined by combination of education, experience, and demonstrated competencies)
Option 1:
Bachelor's degree in Chemistry or related scientific discipline
0-2 years experience (Chemist I) or 3-5 years experience (Chemist II) in chemistry laboratory, quality control, or research and development within the pharmaceutical industry
Option 2:
Master's degree in Chemistry or related scientific discipline
2-3+ years experience in chemistry laboratory, quality control, or research and development within the pharmaceutical industry
Technical Competencies
Intermediate to advanced proficiency in laboratory procedures, analytical equipment operation, and instrumentation maintenance
Strong foundation in safety protocols and laboratory best practices
Comprehensive understanding of chromatographic methods and analytical problem-solving techniques
Thorough knowledge of cGMP regulations and data integrity documentation requirements
Opportunity Awaits.
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