Step up from Manager into a Director Level Position
Work in Beautiful Vermont
About Our Client
Our client is a top 503B Outsourcing Facility located in Colchester, VT, seeking innovative and hard-working individuals to join their growing team.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
- Oversees all laboratory processes and systems (e.g in-process and release testing programs, raw materials, Environmental Monitoring, Stability program, method validation, retain program, and microbiological method suitability).
- Drives compliance at both internal and external laboratories
- Oversee implementation and maintenance of QC instruments, methods, cGMP documents, sample handling, and applicable electronic systems.
- Manages department resources (human resources and financial resources).
- Ensure analytical, microbiological and environmental monitoring programs adhere to current regulatory expectations.
- Ensure QC support to Planning, Operations, and other department for timely release of the products to the clients.
- Provides strong leadership and guidance to laboratory operations and personnel.
- Manages robust laboratory investigations (analytical, micro and environmental monitoring OOS/OOT) to ensure root cause analysis and effectiveness checks are performed.
- Support Annual Product Quality Review (APQR) activities.
- Manages the training and data integrity programs for the laboratories.
- Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment.
The Successful Applicant
- Bachelor's Degree in biological sciences or other relevant field of study. Advanced degree preferred
- Minimum 3 years in a management role overseeing a laboratory environment.
- Experience with environmental monitoring and aseptic processing.
- Knowledge of USP and FDA regulations.
- Understanding of a quality system, including the training, deviations, CAPA management, etc.
- Demonstrated success with written and verbal communication along with good problem-solving skills, and ability to work in a fast-paced environment.
- Excellent project management skills and attention to detail.
- Exceptional at handling multiple, competing demands in a time-sensitive manner.
- In-depth knowledge of current Good Manufacturing Practice principles. Able to identify breach of current Good Manufacturing Practice principles and provide suggested corrective actions.
- Demonstrated ability to work in a collaborative environment with positive interactions and a hands-on approach that emphasizes teamwork, collaboration, motivation, and team building
What's on Offer
- Competitive salary