Senior QC Analyst, Method Development & Validation Team

Croda International•Alabaster, AL

5d•Onsite

About The Position

At Croda, our Quality Control teams apply scientific rigor, data integrity, and continuous improvement to help ensure analytical methods are fit for purpose and capable of producing accurate, compliant results. As Senior QC Analyst, Method Development and Validation, you will support the development, optimization, transfer, verification, validation, and maintenance of analytical methods used to test raw materials, in-process samples, finished products, and stability samples. You will collaborate with Quality Control, Quality Assurance, Manufacturing, and external laboratories while maintaining high standards of scientific and regulatory compliance.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Analytical Chemistry, or a related scientific discipline required.
Two to five years of experience in pharmaceutical, biotechnology, biologics, or another GMP-regulated industry preferred.
Experience performing analytical testing and supporting method validation, verification, or transfer activities preferred.
Working knowledge of ICH, USP, FDA, GMP, and data integrity requirements.
Experience with laboratory investigations, documentation, and regulated laboratory environments preferred.
Working knowledge of analytical method development, validation, verification, and transfer principles.
Experience with one or more analytical techniques: HPLC/UHPLC LC-MS/MS GC ICP-MS UV-Vis FTIR Karl Fischer
Basic understanding of statistical concepts used in method validation and laboratory data analysis.
Experience with laboratory software systems, chromatography data systems, LIMS, and electronic quality systems.
Familiarity with quality systems, data integrity principles, and laboratory investigations.
Technical and scientific aptitude
Critical thinking and problem solving
Attention to detail
Technical writing and documentation
Investigation and troubleshooting
Team collaboration
Time management and organization
Adaptability and continuous learning
Regulatory and GMP compliance awareness
Effective verbal and written communication
Commitment to quality and data integrity

Responsibilities

Support the development, optimization, qualification, validation, verification, and maintenance of analytical methods in accordance with ICH, USP, FDA, EMA, and applicable regulatory requirements.
Execute method development and validation studies for chemical, biochemical, and biological analyses under established protocols and guidance.
Assist with validation protocols, method transfer protocols, technical reports, qualification reports, and supporting documentation.
Perform analytical testing to evaluate accuracy, precision, linearity, specificity, range, detection limits, and quantitation limits.
Support method troubleshooting, optimization, continuous improvement, periodic reviews, updates, and revisions.
Assist with implementing new analytical technologies and laboratory techniques.
Develop proficiency in designated analytical techniques, instrumentation, and laboratory procedures.
Provide technical input and collaborate with analysts, specialists, and cross-functional teams to support laboratory objectives.
Participate in investigations involving out-of-specification, out-of-trend, atypical results, and method performance issues.
Assist in evaluating deviations, change controls, and CAPAs associated with analytical methods and laboratory systems.
Communicate analytical findings and technical observations to laboratory management and project teams.
Support analytical method transfers between internal laboratories, manufacturing sites, and external contract testing organizations.
Perform testing and assist with data evaluation during method transfers and validations.
Collaborate with development and manufacturing teams to implement analytical methods throughout the product lifecycle.
Support process validation, cleaning validation, stability programs, and comparability studies through analytical oversight and testing strategies.
Perform laboratory testing using validated analytical methods and approved procedures.
Maintain compliance with cGMP, GLP, data integrity requirements, and company procedures.
Review analytical test data, laboratory notebooks, electronic records, and reports for accuracy and completeness.
Support routine calibration, maintenance, qualification, and troubleshooting of laboratory instrumentation.
Identify laboratory process-improvement opportunities and communicate recommendations to management.
Maintain laboratory cleanliness, organization, and readiness for internal and external audits.
Prepare and revise SOPs, analytical methods, specifications, protocols, reports, and technical documents.
Ensure documentation complies with ALCOA+ principles and applicable data integrity requirements.
Support document revisions, change controls, and record management associated with analytical methods and laboratory systems.
Assist with audit and inspection readiness by providing documentation and technical support.
Complete required training and maintain qualification on analytical methods, instrumentation, and laboratory procedures.
Support cross-training, knowledge sharing, and training of new laboratory personnel on assigned routine testing procedures.
Expand technical knowledge in analytical techniques and regulatory requirements.
Adhere to health, safety, environmental, and quality requirements and follow safe laboratory practices.
Promptly report safety concerns, equipment issues, and quality events.
Help maintain a safe, compliant, and quality-focused laboratory environment.