QC Microbiology Team Lead
2nd Shift, Wednesday to Saturday, 12:00pm to 10:30pm
Quality Control (QC) is responsible for testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations. Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation.
The Quality Control Operations group supports Laboratory Investigations, Deviation Investigations, CAPA support, Training, and Change Controls. Quality Control Validation Support consists of the Method Validation Group and the Equipment Qualification Group. Quality Control is also responsible for assisting in site wide studies and projects.
This individual is responsible for providing leadership support within the department. The position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP's.
Provide motivation, inspiration, and feedback to staff under general supervision.
Manage and coordinate studies and projects
Act as the primary contact for the team interacting with various departments
Represent the functional area in meetings and compliance activities
Actively troubleshoots routine problems with equipment and methods
Actively participate in manufacturing scheduling meetings
Participate in both internal and external audits
Coordinate daily scheduling and assignments
Perform and review assays as needed
Author/Review technical documents/protocols
Assist with interviewing and onboarding new hires
Act as Document Owner for SOPs and maintain periodic reviews
Run staff daily QDCI/DCM meetings
Actively supports the QC Management team
Completes Phenix Laboratory investigations/Deviations/CAPA/Change Controls
Ensures timely escalation of critical issues
Maintains positive relationships and networks effectively across sites and organizations
Participates in training more junior employees
Ensure all safety requirements are being met within the department including PPE and waste disposal
Facilitates operational excellence through continuous improvement initiatives
- Bachelor’s degree or equivalent and 4 years Quality and/or Operations experience in a cGMP laboratory environment
Bachelor's Degree in a science or technical related field
Knowledge Experience with scientific and technical writing
Knowledge of CGMP regulations for US, EU and other regulatory agencies
Strong computer, verbal, and written communication skills
Strong technical writing skills
Effective skills in time management, organization, teamwork, collaboration, and leadership
Attention to detail
• Phenix or other investigation system experience
Experience in GMP lab environment.
Experience with lab based data management systems.
Experience in a quality control lab.
SPECIAL WORKING CONDITIONS
Work in a laboratory with minimal use of chemicals.
Ability to lift 10 lbs.
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Above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.
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