Position Description Summary:
Manages and coordinates activities and operations of quality assurance department and staff. Designs, develops, implements, modifies, and evaluates SOP's, reports and techniques to ensure a quality deliverable product according to the clients Key Element protocols.
* Directs and coordinates the activities of the quality control function of the network to ensure achievement of company and client Key Element objectives.
* Responsible for creation and overall ownership of quality SOP's. QA must approve all procedures, maintain master files and post copies to shared drive as well as send notification of targeted reviews on a timely basis.
* Responsible for finished product hold and release process and decision making.
* Responsible for overall oversight of validation program and shared responsibility of IQ/OQ/PQ processes. This role will also provide sign off for externally managed validation such as system upgrades.
* Act as site Food Safety and Defense Officer to comply with FDA Food Safety Modernization Act (FSMA) that serves as single point of contact for FSMA systems and responsible for management of the program in total.
* Ensures that quality system requirements are maintained and reported; identifies and investigates in-house quality issues.
* Oversees completion of appropriate documentation to support Key Element program.
* Evaluates current procedures and practices for accomplishing network objectives; develops and implements improvements and/or corrections as needed.
* Develops and implements primary quality control systems consistent with Key Element program and SOPs.
* Ensures that Good Manufacturing Practices (GMP's) are always met.
* Directs and coordinates analysis of products in and out of compliance with GMP regulations and Key Elements. Provides management with timely reviews of the networks status and progress.
* Reviews all data generated in support of the Quality Assurance program; oversees preparation of reports and summaries based on data.
* Directs, facilitates, coordinates and participates in Key Element audits and assumes ownership / leadership of process.
* Coordinates with client, and senior staff to identify and implement opportunities for continuous improvement processes to reduce costs and increase and/or improve quality for all network activities and client service.
* Ensures that network operations comply with federal, state, local, and/or company policies and regulations.
* Interacts and collaborates effectively with internal and external team members to assure needs of the company are met.
The individual in this position must be capable of performing all of the essential functions with or without a reasonable accommodation.
Knowledge and Skills (The following minimum requirements are normal guidelines and should not constrain the advancement of otherwise qualified personnel):
This is a management position. Exceptional interpersonal, analytical, problem-solving, and communication skills required. Must be able to work independently, be self-motivated, demonstrate excellent communication skills, including report writing and speaking effectively to company personnel, outside companies and government agencies to successfully achieve objectives. Bachelor's degree or equivalent required. Generally prefer 10 to 12 years of experience and technical knowledge and related supervisory/management experience and experience in Health and Safety field. Knowledge of warehouse operations and best practices.
DB Schenker is the world's leading global logistics provider - we support industry and trade in the global exchange of goods through land transport, worldwide air and ocean freight, contract logistics and supply chain management. Integrated logistics resides at the world's most important intersections, where the flow of goods creates an effective link between carriers. Our value-added services ensure the flow of goods continues seamlessly and supply chains stay lean and optimized for success. Our business holds top positions in automotive, technology, consumer goods, trade fair logistics, special transports, and special events logistics.
Equal Opportunity Employer