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The Program Associate, Production, reporting to the Director, Global Production Accounts, will be responsible for supporting the activities for Production around the implementation and management of customer-specific production requirements and interface between the production program team & back-office functions.
Responsibilities include documentation management, compliance and sign off of necessary cGMP forms to support customer requirements. This position will work independently with Suppliers and Quality to ensure completeness and accuracy of documentation as well as approve and sign documentation to be returned to customer. Responsibilities will also include coordination of shipment documentation thru the Distribution network as well as monitoring performance to customer specific service level expectations. They will be responsible for triaging and managing the issues with the appropriate functional areas. Issues that require escalation or program modification will be presented to the team with identified potential solutions.
Support customer production program accounts
Support development of customer facing Scope of Work document and MS Project Plan
Support contact with customer for scope changes and modifications
Internal point of contact for communication and relay of information to support the implementation and on-going maintenance
Support documentation requirements with Production Program team: Inventory Planning, Quality, Customer Service, Supplier Management, etc.
Responsible for action items resulting from Change Notifications
Drives escalation process
Ensures results across functional areas to meet requirements
Support monthly audit of safety stock levels and necessary adjustments in conjunction with the inventory planner & program manager
Support periodic (e.g. monthly) Program Reviews with customers, at times at customer facility
Documentation of customer specific and functional SOPS and process flows
Support the management of internal SLAs and report outs to stakeholders on overall program progress
Works closely and support related activities of the sales organization, customer service, supply chain and regulatory to ensure sustainable operations
Leverage continuous improvement methodology and related analytical tools to drive people process & technology improvements
1-2 years relevant business experience: operations, customer implementation, supply chain, sales, marketing, product management, quality, customer service
Understanding of industry/global quality system standards and regulations; ISO 13485, FDA current Good Manufacturing Practices (cGMP, cGxP) preferred
Results oriented, acting with a sense of urgency
Knowledgeable in continuous improvement methodology and related analytical tools, e.g. Six Sigma, Lean, run charts, flow charting, Pareto charts, pivot tables etc.
Non-Negotiable Hiring Criteria:
Must have a Bachelor's Degree in Business, Supply Chain, or a related field, or equivalent combination of experience and education.
Strong written and oral communication skills to express his or her ideas, and communicate well with employees and sales team.
Strong organizational skills to ensure Service Level Agreement is met.
Excellent written and verbal communication skills, problem solving and decision making skills
Proficiency in: MS Office (Word, Outlook, Excel, PowerPoint), SharePoint, Fisher Scientific Mainframe
This position has not been approved for Relocation Assistance.
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