Position OverviewReporting to the Director of Quality Control, the Quality Control (QC) Contractor will join the Technical Operations organization as part of the Quality Control function. This individual will lead the management of the Analytical Reference Materials and Reference Standards (RMRS) program, ensuring compliance with internal quality systems, established procedures, and global cGxP requirements in support of clinical and future commercial manufacturing activities.
This role will oversee the full lifecycle of reference materials and reference standards, including qualification, requalification, inventory management, change control, and continuous improvement initiatives across the Analytical Quality Control and Technical Operations organizations.
In addition, the contractor will support the review of cGMP analytical documentation related to GMP testing of drug substance, regulatory starting materials (RSMs), and synthetic intermediates, as needed.
Key Responsibilities- Lead the management and oversight of the Reference Materials and Reference Standards (RMRS) program.
- Partner cross-functionally to support the synthesis, qualification, certification, release, and ongoing management of analytical reference materials.
- Maintain and oversee the RMRS inventory database to ensure accuracy, traceability, and compliance.
- Perform Quality Control review of analytical data associated with reference material qualification and requalification for completeness, accuracy, and compliance with specifications and protocols.
- Compile, evaluate, and archive qualification and requalification data to support stability assessments, degradation pathway understanding, and lifecycle management.
- Investigate and support resolution of analytical test failures, including out-of-specification (OOS) and atypical results, in collaboration with cross-functional teams.
- Review analytical method validation documentation, raw data, summary reports, and other cGMP analytical records related to regulatory starting materials and manufacturing intermediates.
- Support continuous improvement initiatives within the Quality Control and Technical Operations functions to enhance quality systems and operational efficiency.
Desired Competencies- Strong organizational skills with the ability to effectively manage multiple priorities and meet project timelines.
- Excellent critical thinking and analytical problem-solving abilities with exceptional attention to detail.
- Adaptable and flexible, with the ability to thrive in dynamic, fast-paced environments and respond effectively to changing business needs.
- Strong interpersonal skills with the ability to build collaborative relationships across technical and cross-functional teams.
- Excellent written, verbal, and presentation communication skills.
Qualifications- Bachelor's degree in Chemistry or a related scientific discipline (or equivalent experience).
- Minimum of 4 years of relevant pharmaceutical, biotechnology, or related industry experience.
- Hands-on experience supporting analytical testing for small molecule products.
- Experience managing analytical reference materials and reference standards programs is preferred.
- Proficiency with JMP and application of statistical analysis methodologies is highly desirable.
- Previous experience supporting stability programs is considered an advantage.
- Working knowledge of cGMP and global quality regulations applicable to analytical laboratory operations.
