Quality Control Specialist - Microbiology

Job Title: Quality Control Specialist - Microbiology

Reporting to: Head of Quality Control or Quality Control Senior Specialist

Department: Quality Control

Location: Baltimore Maryland

About Syngene

Incorporated in 1993 Syngene International Ltd. is an innovation-focused global discovery development and manufacturing organization providing integrated scientific services to the pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb Baxter Amgen GSK and Merck KGaA. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems improve R&D productivity speed up time to market and lower the cost of innovation.

At Syngene safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability including following safety guidelines procedures and SOPs in letter and spirit.

Job Summary

The Quality Control (QC) Specialist Microbiology will support QC Microbiology at a large molecule manufacturing plant. This role is critical to ensuring that QC Microbiology functions are aligned with regulatory requirements company objectives and industrys best practices. The incumbent will be accountable for supporting the QC Microbiology team working under the Head of Quality Control in Baltimore. The incumbent will support the QC microbiology strategy for the site interface with regulatory authorities and partner cross-functionally with Manufacturing Quality Assurance Regulatory Affairs and Supply Chain to ensure timely analysis and inspection readiness.

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Primary Responsibilities

• Responsible for Quality Control (QC) Microbiology operations including product support for stability studies raw material microbiology lab and packing material testing ensuring compliance with Good Laboratory Practices (GLP) and applicable regulatory requirements.
• Support the Environmental Monitoring program for the Bayview Baltimore site including the Environmental Monitoring Process Qualification (EMPQ).
• Perform routine microbiological tests on raw materials on intermediate and finished products and for facility utilities such as water gas and environmental sampling.
• 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.
• Complete 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).
• Ensure all documentation including SOPs IOPs EOPs and STPs is periodically reviewed updated and maintained as per the documentation control system.
• Actively participate in functional and cross-functional teams to ensure Biologics product testing is conducted in compliance with current Good Manufacturing Practices (cGMP).
• Adhere to ALCOA principles of data integrity for self and ensure compliance by team members.
• Support investigations and ensure closure of client and regulatory audit observations related to QC Microbiology.
• Follow lab safety protocols at all times.
• Monitor QC microbial trends complaints failures deviations and changes to identify opportunities for process system and product improvements.

Education & Qualifications

• Education: Bachelors degree in Chemistry Biochemistry Chemical Engineering or a related scientific discipline is required; Masters degree is desired.
• Experience: 2-5 years of progressively responsible experience in Quality Control within biologics or pharmaceutical manufacturing environments specifically for large molecule products.
• Regulatory Knowledge: Awareness of USDA and USFDA ICH EU and Health Canada regulations as well as USP and other pharmacopeial standards relevant to biologics manufacturing.
• Audit Experience: Some experience supporting regulatory inspections and third-party audits.
• Technical Expertise: Some working knowledge of biologic analytical techniques and validation of methods.
• Leadership Skills: Participate in cross-functional teams build relationships across departments and foster a culture of quality compliance and accountability.
• Training & Development: Support quality systems qualifications and validations and product lifecycle quality management.
• Continuous Improvement: Support 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.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age colour national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.