Senior QC Validation Chemist

SUMMARY

We are seeking an experienced Senior QC Validation Specialist to support quality control and analytical validation activities within a regulated pharmaceutical manufacturing environment. This hands-on laboratory role focuses on supporting routine QC operations, analytical method validation and verification, stability programs, batch release testing, and manufacturing support initiatives for solid oral dosage products. The ideal candidate is highly detail-oriented, comfortable working in a fast-paced production setting, and capable of independently troubleshooting analytical challenges while maintaining compliance with cGMP and data integrity standards.

RESPONSIBILITIES

• Perform and support routine laboratory testing for pharmaceutical products, including assay, dissolution, impurity profiling, related substances, and content uniformity analysis.
• Execute analytical method validation, method verification, and method transfer activities for QC and manufacturing support.
• Conduct batch release and stability testing in accordance with established procedures and regulatory requirements.
• Operate and troubleshoot analytical instrumentation including HPLC, UPLC, dissolution systems, GC, UV-Vis, FTIR, and Karl Fischer titration equipment.
• Review analytical data for accuracy, completeness, and compliance with regulatory and internal quality standards.
• Assist with investigations related to OOS, OOT, deviations, and CAPA activities while supporting root cause analysis efforts.
• Prepare, review, and maintain validation protocols, technical reports, SOPs, and other GMP documentation.
• Support laboratory compliance initiatives related to FDA, cGMP, ICH, ALCOA\+, and data integrity expectations.
• Collaborate cross-functionally with manufacturing, quality assurance, and technical teams to support production timelines and continuous improvement efforts.
• Maintain audit-ready documentation and ensure laboratory activities align with established quality systems.
• Utilize laboratory software systems such as Empower and LIMS for data acquisition, review, and documentation.

QUALIFICATIONS

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline preferred.
• Minimum of 10 years of pharmaceutical quality control and/or analytical laboratory experience within a regulated manufacturing environment.
• Strong hands-on experience with HPLC and UPLC instrumentation is required.
• Experience supporting solid oral dosage manufacturing environments, including tablets and capsules.
• Proven background performing dissolution, assay, impurity, related substances, and content uniformity testing.
• Experience supporting analytical method validation, verification, and method transfer activities.
• Strong understanding of cGMP regulations, FDA expectations, ICH guidelines, and data integrity requirements.
• Experience supporting stability testing programs and batch release activities.
• Ability to independently troubleshoot analytical methods, instrumentation, and laboratory issues.
• Prior experience handling OOS/OOT investigations, deviations, and CAPA documentation.
• Familiarity with laboratory systems including Empower and LIMS.
• Strong written communication skills with the ability to generate technical reports, SOPs, and validation documentation.

BENEFITS

• Opportunity to work in a highly technical pharmaceutical manufacturing environment with advanced analytical instrumentation.
• Exposure to validation, stability, and QC operations that support critical production activities.
• Collaborative team environment with opportunities to contribute to process improvements and regulatory compliance initiatives.
• Stable, production-focused laboratory setting with hands-on involvement in analytical troubleshooting and technical problem solving.
• Opportunity to expand expertise in pharmaceutical quality systems, validation programs, and manufacturing support operations.