Supervisor, Quality Control

美国 - 马里兰州 - 弗雷德里克质量正式员工

Key Responsibilities:

Oversee daily operations and testing activities within the QC Microbiology Laboratory.
Ensure timely and compliant execution of microbiological testing to support manufacturing and product release.
Perform routine review and approval of test data, laboratory records, and associated documentation.
Support the generation and review of Certificates of Analysis (CoAs) for product release.

Lead and sustain the site's Environmental Monitoring (EM) and Utilities Monitoring (UM) programs.
Monitor environmental and utility data, identify trends, and communicate findings to management.
Assemble reports and provide routine updates on environmental monitoring performance and compliance.
Implement corrective and preventive actions when adverse trends or excursions are identified.
Support optimization of the aseptic gowning qualification and training program.

Supervise QC Microbiology staff and laboratory activities.
Conduct performance evaluations, coaching, and regular employee development discussions.
Maintain training programs and ensure ongoing qualification of QC Microbiology personnel.
Foster a culture of quality, compliance, accountability, and continuous improvement.

Serve as Subject Matter Expert (SME) for EM and UM investigations.
Lead or support investigations involving:
- Environmental monitoring excursions
- Utilities monitoring excursions
- Out-of-Specification (OOS) results
- Deviations associated with microbiological procedures
Identify root causes and implement effective corrective and preventive actions (CAPAs).

Develop, review, revise, and approve:
- Standard Operating Procedures (SOPs)
- Validation and qualification protocols
- Validation and qualification reports
- Controlled quality documentation
Monitor GMP systems to ensure continued compliance with internal procedures and regulatory requirements.
Review proposed changes to methods, procedures, systems, and regulatory submissions as needed.

Support internal, customer, and regulatory inspections and audits.
Ensure laboratory activities remain compliant with cGMP requirements and company quality standards.
Represent the QC Microbiology function during cross-functional, site, and global meetings.

Collect and analyze departmental metrics to drive continuous improvement initiatives.
Provide updates and key performance indicators during daily, weekly, and management meetings.
Collaborate with Manufacturing, Quality Assurance, Validation, Facilities, and other functional groups to support site objectives.
Perform additional responsibilities and special projects as assigned.

Bachelor's degree in Microbiology, Biology, Biochemistry, Life Sciences, or related scientific discipline with at least 5 years of experience in QC Microbiology within a pharmaceutical, biotechnology, cell therapy, or other GMP-regulated environment.
Previous supervisory or leadership experience managing laboratory personnel.
Strong experience with:
- Environmental Monitoring (EM)
- Utilities Monitoring (UM)
- Aseptic processing and gowning qualification
- OOS, deviation, and CAPA investigations
- Product release support
Working knowledge of FDA, EMA, and cGMP regulations.

Strong understanding of microbiology laboratory operations within a cGMP environment.
Expertise in environmental monitoring programs, data trending, and contamination control principles.
Proven ability to lead investigations and perform root cause analysis.
Excellent leadership, coaching, and employee development skills.
Strong technical writing and documentation review capabilities.
Effective verbal and written communication skills with the ability to interact across all levels of the organization.
Ability to manage multiple priorities in a fast-paced manufacturing environment.
Demonstrated commitment to quality, compliance, and continuous improvement.