Description
The QC Microbiology Supervisor will be responsible for leading the
implementation and maintenance of drug quality control systems and
activities, equipment and procedures, support of production activities,
staff development and project management. Ensures assays are validated to
meet cGMP requirements, and provides QC testing services to internal
clients, in support of process development, manufacturing, and stability
evaluation. Aids in the development and monitoring of the department budget;
justifies capital expenditures. Assists in resource planning, hiring,
training as well as overseeing a staff of analysts. The QC Microbiology
Supervisor will also review and approve technical data used for lot release
and in regulatory filings.
Implement and maintain quality control systems.
Schedules assays, personnel and equipment to ensure timely completion of
projects.
Develops staff to improve individual and departmental performance. Trains
members of department and other departments as necessary.
Balances priorities and resolves conflicts within groups.
Ensure cGMP Compliance.
Supervises QC staff to perform duties to support production.
Reviews data generated in the laboratory prior to release of information.
Ensures timely and appropriate communication of results.
Troubleshoots problems that arise which affect the routine operations within
the QC functional group.
Attends meetings to support validation and production efforts and schedules
testing.
Generates Standard Operating Procedures and protocols developed for routine
testing special studies and validation efforts
Communicates policies and procedures to QC staff.
Communicates issues and questions to and from staff and management.
Discusses options with higher levels as applicable.
Reviews validation protocols and reports as necessary.
Participates in laboratory testing as appropriate.
Designs and implements methods to increase efficiency and productivity of
raw material and analytical chemistry functions.
Oversees validation of test methods to support release of materials for
production or products for commercial or clinical use. Optimizes test
procedures to improve efficiency whenever possible. Documents and reviews
test results in order to meet regulatory requirements.
Assists in validation of new equipment to ensure equipment is in working
order. Recognizes, troubleshoots, and resolves moderately complex problems
with equipment or individual assays.
Oversees transfers of test methods from R&D and Clients to the QC Analytical
group.
Qualifications
BS/BA in a scientific field.
Minimum of 6 years Microbiology experience in the pharmaceutical/biotech
industry.
Minimum of 2 years supervisory experience is preferred.
Comprehensive scientific knowledge and extensive analytical skills
Excellent communication and interpersonal skills
Please contact eric at onescience.com for more information
