Job Details:
Responsible for the on site oversight of operation of multiple areas of the organization’s logistics, administrative, and quality activities at Sentry’s BioPharma Services, Inc.’s Columbus facility. Accountable for overseeing that the operation is providing quality, cost effective, and compliant services. Key responsibilities include supervision of site personnel, acting as a liaison for site personnel and Quality and Operations management, assisting upper management, site operations, regulatory compliance, budgeting, and administration.
Essential Duties & Responsibilities:
- Participate with other members of the management team to define company goals and objectives.
- Lead and/or participate in the development and implementation of processes designed to achieve organizational/business objectives.
- Contribute to development and management of operating budgets.
- Develop and report key performance indicators and performance objectives and ensure that all metrics and performance objectives are met.
- Oversee daily quality operations including but not limited to:
- Verifications of incoming and outgoing shipment information.
- Deviations and CAPA.
- Internal/external validation and calibration activities.
- Releases of labels, drug products, etc.
- Review, and/or approval of facility records (preventative maintenance, pest control, facility walk throughs, etc.).
- Writing, revision, and review of SOPs, COPs, or training material.
- Support of internal, Client, and regulatory audits/inspections.
- Oversee daily logistics operations including but not limited to:
- Materials flow (both receiving and shipping).
- Inventory control.
- WMS systems as relates to logistics operations.
- Accuracy of materials movements and supporting documentation.
- Accurate documentation of inventory transactions, cycle counts and reconciliation activities.
- Compliance with Standard Operating Procedures (SOPs) for logistics operations.
- Compliance with Client Operating Procedures (COPs) for customized client needs.
- Product segregation and identification/location.
- Proper documentation for import/export materials movements.
- Proper labeling, documentation for hazardous goods shipments.
- Oversee daily facilities including but not limited to:
- Building Monitoring System operation.
- Equipment preventive maintenance and repairs.
- Facility cleaning and sanitation.
- Warehouse layout, organization, and appearance.
- Security (of both facility & materials).
- Consistent adherence to applicable safety procedures.
- Supervise personnel including providing oversight, training, evaluation, and discipline, as needed.
- Participate in client meetings and/or discussions to develop/maintain client relationships.
- Evaluate new vendors/suppliers/contractors. Interact with same to discuss issues, performance and future strategies.
- Proactively search for innovative ways to manage the operation, improve quality of service, increase efficiency of personnel and equipment performance.
- Assist in response to after-hours alarm situations and/or emergencies as needed.
- Additional duties as assigned from time-to-time by the Executive Vice President.
Qualifications:
- Self-starter with the ability to translate organization goals into practical objectives and ultimately achieve results through direction of others’ efforts.
- Excellent leadership skills including the ability to lead projects with a broad scope and cross-functional nature and an ability to impact outside own department while promoting teamwork between departments.
- Strong problem solving, negotiating, solutions orientation and presentation skills.
- Embraces change and is dedicated to continuous improvement. Consistently searching for more efficient and effective ways to improve processes and procedures.
- Excellent communication skills with all levels of the organization and ability to develop rapport with other functional leaders within the company to make decisions.
- Drives results through team leadership. This would include working with the team/individual to define specific goals and progress measuring tool.
- Works to maintain high level of associate morale and recognition.
Education and/or Experience:
Three to five years of work experience in a team leadership or management position requiring oversight of operations, costs/budgeting, and attention to detail.
BS or BA degree in a related field is preferred. A higher degree would be beneficial. Previous experience in pharmaceutical operation and/or knowledge of Good Manufacturing Practices and pharmaceutical quality compliance a plus. |
Location: Columbus, IN
Department: Administration
Schedule: Full Time, On-Site
Experience: 3-5 Years, Team Leadership/Management (Required)
Education: BS or BA in Related Field
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