Job Title: Specialist - Quality Control Microbiology
Reporting to: Head of Quality Control Microbiology
Department: Quality Control
Location: Baltimore, Maryland
Job Summary
The Specialist - Quality Control Microbiology (QC Microbiology), will serve as an analyst/specialist for the Microbiology side of the QC unit at a large molecule manufacturing plant. The incumbent will work within the QC Microbiology group for the site and partner cross-functionally with QC Analytical, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure timely analysis and inspection readiness. This role is a working Specialist role, and will include hands-on QC work, including sampling and testing, as well as working with analysts and specialists within QC Microbiology group to develop, qualify/validate, and transfer methods.
Primary Responsibilities
- Responsible for working in Quality Control (QC) Microbiology 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 Microbiology tests, including for utility, raw material, in-process and product, and stability.
- Coordinate with Quality Assurance (QA), and other departments to ensure development and transfer of microbiology tests and methods.
- Ensure qualification, validation, performance, and transfer of Microbiology 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 Microbiology.
- Ensure lab safety protocols are followed at all times and resolve technical issues in the QC Microbiology lab effectively.
- Support QC Microbiology documentation in regulatory filings, including Prior Approval Submissions, renewals, updates, and supplements, as required.
- Support monitoring of QC microbiology 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;
- Experience: 5-8 years of progressively responsible experience 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 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 Microbiology lab.
