The Role
Manage and supervise daily supply chain operations for pharmaceutical manufacturing, ensuring material receipt, storage, transport, and inventory distribution meet cGMP and regulatory requirements. Coordinate cross-functional teams, master production schedule, metrics, cost tracking, audits, SOP/CAPA documentation, and system improvements while supporting non-standard shifts.
Summary Generated by Built In
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Qualifications:
Responsibilities:
- Provides Supply Chain work group supervision and technical expertise in support of successfully completing daily operations within scope of responsibility.
- Provide meeting support to several cross-functional teams. Set project timelines and priorities based on project objectives and ongoing assignments.
- Create, analyze, and present metrics. Work closely with Supply Chain Operations and Planning teams to ensure product and material requirements are managed.
- Tracks and reports on spend to budget. Provides input to management for cost reduction opportunities.
- Comply with safety guidelines, cGMPs and other applicable regulatory requirements.
- May participate in area investigations/ audits.
- Maintain training proficiency.
- Initiate and/or implement changes in controlled documents.
- Participate in audits, initiatives and projects that may be departmental or organizational in scope.
- Initiate and complete routine investigation and technical tasks.
- Ensures all work is completed with minimal disruption and in compliance with all cGMP guidelines and Amgen procedures.- Direct and coordinate daily activities of personnel responsible for material receipt, storage and transport.
- Ensures materials are received, stored and transported according to established performance standards and all applicable procedures and regulations.
- Interacts with internal and external regulatory agencies to ensure compliance with cGMP, DOT, OSHA requirements.
- Collaborate with other sites to maintain optimal flexibility for the storage of all materials and product.- Identify and oversee implementation of new and improved business and compliance systems and tools.
- Organize and communicate on a regular basis the total demand and supply requirements to senior management.
- Coordinate the Master Production Schedule for Finished Goods and effectively communicate any impact created by, and to the supply plan.
- Manage the preparation and communication of the Company wide Inventory Distribution Plan to achieve corporate goals of customer satisfaction and risk management.
- Develop and coordinate the long-range production requirements based on Marketing forecasts, product approval and release timelines, clinical requirements, SKU put-up information and business planning timelines estimates.
Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or related field.
- 4 years of directly related experience
- Must have well developed skills from Supervisor I
- Proficient in SAP
- Proficient in Excel, Word, Power Point, Smartsheet and other analytics software
- Knowledge documenting SOPs, deviations and/or CAPA records
- Veeva and SOP Management experience
- Fluent in English and Spanish
- Availability to support non-standard shift operation and extended hours
- Ability to adapt to multiple and increasing responsibilities, priorities, tasks, and projects simultaneously.
- Administrative Shift
Skills Required
- Bachelor's degree in Life Sciences, Engineering, or related field
- 4 years of directly related experience
- Well developed skills from Supervisor I
- Proficient in SAP
- Proficient in Excel, Word, PowerPoint, Smartsheet
- Knowledge documenting SOPs, deviations and/or CAPA records
- Veeva and SOP Management experience
- Fluent in English and Spanish
- Availability to support non-standard shift operation and extended hours
- Ability to adapt to multiple and increasing responsibilities, priorities, tasks, and projects
- Administrative shift availability
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
