Specialist – Quality Control Analytical

Primary Responsibilities

• Responsible for working in Quality Control (QC) Analytical operations, including product support for stability studies, raw material, ensuring compliance with Good Laboratory Practices (GLP) and applicable regulatory requirements.
• Operate as the specialist in performing routine sampling and testing for all analytical tests, including for utility, raw material, in-process and product, and stability.
• Cook with Quality Assurance (QA), and other departments to ensure development and transfer of analytical tests and methods.
• Ensure qualification, validation, performance, and transfer of analytical methods within the QC department.
• Interact with clients and project teams to ensure seamless execution of project-related activities.
• Collaborate with the Biologics Process Development team to plan and execute testing activities in support of drug substance development and manufacturing.
• Ensure that laboratory incidents, out-of-specifications (OOS), deviations, out-of-trend (OOT) results, and client complaints related to QC testing are thoroughly investigated, root causes identified, and corrective and preventive actions (CAPA) implemented in a timely manner.
• Ensure all documentation, including SOPs, IOPs, EOPs, and STPs, is periodically reviewed, updated, and maintained as per the documentation control system.
• Ensure timely completion of QC activities as per project timelines. Update work plans periodically to accommodate changes in project scope, priorities, or timelines.
• Adhere to ALCOA principles of data integrity for self and ensure compliance by team members.
• Participate in functional working teams for self-assessment of compliance to SOPs and data integrity standards.
• Support preparation and timely closure of audit action plans and escalate concerns appropriately.
• Support investigations and closure of client and regulatory audit observations related to QC Analytical.
• Ensure lab safety protocols are followed at all times and resolve technical issues in the QC Analytical lab effectively.
• Support QC Analytical documentation in regulatory filings, including Prior Approval Submissions, renewals, updates, and supplements, as required.
• Support monitoring of QC analytical trends, complaints, failures, deviations, and changes to identify opportunities for process, system, and product improvements.

Education & Qualifications

• Education: Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline is required;
• Subject Matter Expert in Quality Control within biologics or pharmaceutical manufacturing environments, specifically for large molecule products.
• Regulatory Knowledge: Understanding of USDA and USFDA, ICH, EU, and Health Canada regulations, as well as USP and other pharmacopeial standards relevant to biologics manufacturing.
• Audit Experience: Experience supporting regulatory inspections and third-party audits.
• Technical Expertise: Working knowledge of biologic analytical techniques and validation of methods.
• Leadership Skills: Ability to lead cross-functional teams, build relationships across departments, and foster a culture of quality, compliance, and accountability.
• Training & Development: Experience working within quality systems, qualifications and validations and product lifecycle quality management.
• Continuous Improvement: A track record of driving successful continuous improvement projects to enhance efficiency, reduce deviations, and increase product quality.

Additional Competencies

• Experience in bioanalytical and bioassay methods for monoclonal antibodies and other biologic molecules.
• Plan and manage resources for smooth operations in the QC analytical lab.