QC Chemistry LeadWHAT WE ARE LOOKING FORThe QC Chemistry Lead operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization's framework, company's procedures, and the defined scope of responsibility the role is accountable for.
At the Guerbet Raleigh Imaging manufacturing facility, the Quality Control Lead is responsible for overseeing analytical testing and quality assurance processes within the chemistry lab. This role ensures compliance with cGMP (Current Good Manufacturing Practices), ICH guidelines, and regulatory standards while leading a team of chemists to maintain the integrity and accuracy of pharmaceutical products.
YOUR ROLE- Lead, support, and mentor a team of QC chemists, ensuring adherence to laboratory protocols and regulatory requirements.
- Oversee the testing of raw materials, in-process samples, finished drug substances, and stability studies to ensure product quality.
- Implement and maintain quality control procedures to ensure compliance with FDA, EMA, and other regulatory agencies.
- Conduct investigations into out-of-specification (OOS) results and deviations (EXC), implementing corrective and preventive actions (CAPA).
- Ensure proper documentation and data integrity in accordance with Good Laboratory Practices (GLP).
- Collaborate with cross-functional teams, including quality assurance, manufacturing, and regulatory affairs, to support product development and release.
- Maintain and troubleshoot laboratory instruments such as HPLC, FTIR, UV-Vis Spectrophotometers, and other analytical equipment.
- Lead audits and inspections, ensuring readiness for regulatory reviews.
- Provide training and guidance to QC staff on analytical techniques and compliance standards.
- Ensure testing is performed in compliance with USP/EP/JP and internal specifications, SOPs, and cGMP standards.
- Participate in method transfers, validations, and verifications.
- Maintain lab readiness for regulatory inspections and internal audits.
- Train, mentor, and evaluate lab analysts; ensure proper documentation and lab safety practices.
- Support continuous improvement projects, including implementation of new equipment, methods, or automation tools
- Performs other duties as assigned by management
YOUR BACKGROUND- Education: Bachelor's or Master's degree in Chemistry, Biochemistry, or a related scientific discipline.
- 5+ years of pharmaceutical QC laboratory experience with a strong background in analytical chemistry.
- 1-3 years in a leadership or senior analyst role preferred.
- Proficiency with HPLC, GC, UV-Vis, FTIR, titrations, wet chemistry.
- Familiarity with LIMS, CDS (e.g., Empower), and laboratory instrumentation qualification.
- Strong understanding of cGMP, FDA, ICH, and USP guidelines.
- Knowledge of industry regulations and best practices for data integrity.
- Effective communication and problem-solving skills.
- Thorough knowledge of cGMPs and pharmaceutical manufacturing requirements
- Demonstrated auditing and corrective action proficiency.
- Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues.
Cognitive Requirements:- Ability to read and understand military time.
- Experience in data quality control, auditing, or regulatory compliance.
- Strong analytical skills and attention to detail.
- Excellent leadership and team management abilities.
- Proficiency in data management tools and software.
- Excellent problem solving and decision-making skills.
- Ability to manage and drive change
- Ability to prioritize tasks and lead a team in a fast-paced, regulated environment.
- Computer skills
- Knowledge of document management/quality systems
- Ability to manage projects and processes with multiple functional groups without direct reporting authority
- Strong communication and interpersonal skills
- Getting work done through others that are not direct reports
- Operates with minimal direction, self-starter
- Building relationships with other departments
