Specialist QC Microbiology

Syngene International Limited•Baltimore, MD

9d•Onsite

About The Position

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, and 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.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline is required.
5-8 years of progressively responsible experience in Quality Control within biologics or pharmaceutical manufacturing environments, specifically for large molecule products.
Understanding of USDA and USFDA, ICH, EU, and Health Canada regulations, as well as USP and other pharmacopeial standards relevant to biologics manufacturing.
Experience supporting regulatory inspections and third-party audits.
Working knowledge of biologic techniques and validation of methods.
Ability to lead cross-functional teams, build relationships across departments, and foster a culture of quality, compliance, and accountability.
Experience working within quality systems, qualifications and validations and product lifecycle quality management.
A track record of driving successful continuous improvement projects to enhance efficiency, reduce deviations, and increase product quality.
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.

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.