What are the responsibilities and job description for the Quality Control Chemist position at Clinical Resource Network (CRN)?
Our client is looking to fill the role of Quality Control Chemist!
Responsibilities:
Technical Expertise & Analysis
Education & Experience Position level is determined by education, experience, and demonstrated competencies:
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.
Opportunity Awaits.
Responsibilities:
Technical Expertise & Analysis
- Apply advanced knowledge of testing methodologies and instrumental analysis techniques across all sample types and procedures
- Execute complex physical and chemical testing of raw materials, intermediates, and finished products per documented procedures to support product release and process validation
- Conduct advanced troubleshooting and maintenance of laboratory instrumentation
- Demonstrate proficiency in operating instrument software, configuring complex sequences, and troubleshooting technical issues
- Report analytical data while executing sophisticated test methods using UV, FTIR, GC, HPLC, and IC instrumentation
- Independently perform swabbing and analysis of complex manufacturing equipment in compliance with cGMP guidelines
- Contribute expertise to cleaning-related investigations and issue resolution
- Manage and maintain equipment calibrations with appropriate documentation review
- Review instrument qualification documents supporting change control initiatives
- Partner with vendors during equipment installation and preventive maintenance activities
- Investigate Out of Specification (OOS) results, Out of Trend (OOT) results, and deviations per cGMP requirements
- Support management in completing investigation reports and assessing product impact
- Participate in customer and regulatory audits, focusing on data integrity and instrument file reviews
- Author, revise, and update laboratory test methods and Standard Operating Procedures
- Maintain laboratory notebooks and files in full compliance with cGMP and internal SOPs
- Conduct peer reviews and audits of colleague work to verify GMP compliance
- Audit laboratory testing data as needed
- Support method validation and method transfer activities
- Train Chemists, Lab Assistants, and temporary staff
- Provide guidance to less experienced chemists on LIR/OOS procedures and data reporting
- Consistently perform testing with minimal need for investigations or repeat analyses
- Accurately report test data in various formats
- Lead cost reduction and process improvement initiatives
- Adhere to all safety procedures and regulations
Education & Experience Position level is determined by education, experience, and demonstrated competencies:
- Bachelor's degree in Chemistry or related scientific discipline
- Chemist I: 0-2 years of experience in a chemistry, quality control, or R&D laboratory within the pharmaceutical industry
- Chemist II: 3-5 years of relevant laboratory experience
- OR Master's degree in Chemistry or related field with 2-3 years of pharmaceutical laboratory experience
- Moderate to advanced proficiency in laboratory procedures, equipment operation, instrumentation, and safety protocols
- Strong understanding of chromatography methods and analytical problem-solving
- Comprehensive knowledge of cGMP regulations and data integrity documentation requirements
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.
Opportunity Awaits.