Senior Compliance Specialist, Supply Chain & Warehouse

Overview

 

 

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FDB call Genki. 

 

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

 

Summary: The Senior Compliance Specialist owns all Supply Chain CAPAs, change controls and deviations. Leading all Supply Chain deviation investigations through to completion.  Support all internal and external audits.  Work collaboratively with cross functional groups including Quality Assurance to support ‘on-time’ release and disposition of batches and other post-execution activities.  Supports all Shipping documents and supports the Shipping Lead in document creation and approvals.

 

 

External US

Essential Functions:

• Drive all deviation, CAPA, and change control closure for Supply Chain by supporting and leading any required investigations, communications or other required actions.
• Own all Root Cause and Problem Analysis Investigations.
• Works collaborately with site management to instill a “Quality Culture” by coaching Supply Chain staff in the application of cGMP Principles including the underlying rational for those principles.
• Work with Quality Management to implement quality systems that will enable the cGMP receipt, storage, issuance and reconciliation of materials in support of Clinical through Commercial Manufacturing.
• Responsible for Supply Chain audit preparations as well as be the point of contact for internal, external and regulatory audits.
• Coordinate SOP and required protocol document creation, review and approvals.
• Leads the completion of periodic review of all assigned procedures and work instructions.
• Provides and maintains metrics around deviation, CAPA, Change Controls, audit observations, shipping completions and Cycle Count results.
• Drives continuous improvement for all procedures and batch related documents.
• Perform other duties and projects as assigned and required.

 

Required Skills & Abilities:

• Must have a working knowledge of cGMP regulations associated with the production of a biologic drug product.
• Must have an understanding of the aspects related to cGMP warehousing.
• Proficient user of deviation management systems such as Trackwise.
• Proficient user of quality document control systems such as Mastercontrol.
• Strong computer skills with quick learning ability.
• Excellent verbal and written communication skills required for discussing complex business processes.
• Ability to coordinate, facilitate and organize resources.
• Ability to develop strategic relationships.
• Ability to work effectively under extreme pressure to meet deadlines.
• Well organized with ability to handle multiple activities simultaneously.
• Detail oriented and accurate.
• Excellent computer skills and proficient in MS Office (Word, Excel, Outlook, PowerPoint). Future- oriented, new technology knowledge.
• Strong analytical and logical problem solving skills.
• Ability to develop and maintain business and technical documentation.
• Positive, customer service oriented skills and behavior.

 

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

• Experience prolonged sitting, some bending, stooping and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calcula