Senior QC Analyst, Method Development and Validation
Advance Analytical Science that Supports Reliable Pharmaceutical Quality
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.
Core Responsibilities
Analytical Method Development and Validation
- 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.
Technical Leadership and Scientific Expertise
- 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.
Method Transfer and Validation Support
- 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.
Laboratory Operations and Compliance
- 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.
Documentation and Regulatory Support
- 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.
Training, Safety and Quality
- 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.
Expertise and Experience
- 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.
Technical Skills
- Working knowledge of analytical method development, validation, verification, and transfer principles.
- Experience with one or more analytical techniques:
- 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.
Core Competencies
- Technical and scientific aptitude
- Critical thinking and problem solving
- Technical writing and documentation
- Investigation and troubleshooting
- Time management and organization
- Adaptability and continuous learning
- Regulatory and GMP compliance awareness
- Effective verbal and written communication
- Commitment to quality and data integrity
Working at Croda
The successful candidate will receive a competitive salary and benefits package, including:
- Excellent Medical, Dental, and Vision coverage, available immediately
- Company-paid and voluntary Life and AD&D insurance
- Short- and long-term disability
Additional Information
This position is on-site at the Alabaster, Alabama facility.
This position has no supervisory responsibilities.
If you require any reasonable adjustments during the hiring process or experience any issues with our online application process, please email [email protected].
Why Croda?
At Croda, we believe our people are our difference. We are people-led, driven by the desire to do good and deliver value, a unifying principle shaped by all the great people who have travelled through Croda since our beginning in 1925. Guided by our values of Responsible, Innovative, and Together, we bring together diverse teams and talents from across the globe and are passionate about building an inclusive, collaborative, and diverse organization with innovation and customer focus underpinning all that we do.
Equal Opportunity Employer
Croda recognizes employees as our strength, and the diversity they bring to our workforce is directly linked to our ongoing success. We are an equal opportunity employer and place a high value on diversity and inclusion. We do not discriminate on the basis of any protected attribute, including age, race, color, religion, national origin, gender, sexual orientation, gender identity, gender expression, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs. This organization participates in E-verify.
