Materials Control Lead

Job Summary:

 

The Materials Control Lead, is a leader who is actively engaged in leading, planning, organizing, and driving the daily and weekly operations while following the highest-level of safety standards for the employees. This hands-on supervisor will confirm proper receiving, storing, and issuing of all items received from suppliers, clients, and other Abzena sites, ensuring a smooth and consistent operation while maintaining compliance with FDA regulations cGMP, GDP, OSHA, IATA, and DOT regulations. This person will be responsible for training and developing the line reports.

Key Responsibilities:

• Ability to perform, teach and lead all the functions required by Material Control I and II.
• Ensure the work performed is within the Code of Federal Regulations Title 21, Quality Management System, Standard Operation Procedures (SOP’s), Work Instructions, comply with all documentation needs, and practices.
• Build and foster productive cross-functional relationships to ensure on-time support to internal customers.
• Assist with the planning/scheduling of raw material kit builds and transfers in accordance with production schedule and material requests.
• Assist in achieving department goals and key performance indicators (KPIs). Monitor ongoing performance in alignment with site and department goals and take necessary action to achieve targets.
• Ensure thorough, accurate, and timely data entry is maintained in the inventory control systems.
• Provide recommendations and assists with continuous process improvement (CPI) efforts to optimize current processes and to ensure safety, quality and efficacy of workflows and spaces.
• Review, update, and suggest changes, as appropriate, to department standard operating procedures (SOPs).
• Ensure all employees are following safety policies and procedures and to actively maintain a safe work environment.
• Ability to successfully adapt to changing priorities.

 

Typical Duties Include:

 

• Ensure work is done within the Quality Management System (QMS), comply with good documentation practices cGMP, GDP, and SOPs.
• Oversite on all activities from receiving to shipping of materials. Coordinate with internal clients, Purchasing, Accounts Payable, Planning, Manufacturing, Process Development and Quality to resolve any supplier invoice issues or discrepancies.
• Coordinate with Quality personnel, ensuring timely quarantine and release of materials.
• Ensure material control through cycle counts. Identify expiring, obsolete, and excess materials and coordinate disposition.
• Communicate status regarding back order of critical material.
• Prepare materials for shipment, to include pack out, preparing import/export shipping documents and coordinating international shipments.
• Maintain organization of work areas through 6S (sort, set, standardize, shine, sustain, safety).
• Operate heavy equipment and vehicles to move materials Perform other related duties as assigned.

 

General Responsibilities:

 

• Operates to the highest ethical and moral standards.
• Complies with Abzena’s policies and procedures.
• Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.
• Communicates effectively with managers, colleagues, and staff.
• Ensure staff is working safely, maintain quality expectations, improving productivity and looking for ways to reduce costs.
• Ability to participate effectively as a team player in all aspects of Abzena’s business.
• Travels as needed between sites, to attend professional conferences, and train on new technologies.
• Lead special projects to improve operations within and outside of department.

 

Qualifications/ Skills Required:

 

• Minimum high school diploma.
• Minimum 3- 6 years’ experience in materials operations environment, preferably the life sciences industry.
• Knowledge of transportation logistics, both domestic and international shipping required.
• Expert knowledge of GMP, GLP, GDP documentation practices, cycle counting, physical inventory.
• Experience with Enterprise Resource Planning (ERP) systems (e.g IFS, QAD, SAP, MS Dynamics).
• Ability to successfully adapt to changing priorities.
• Valid Driver’s License with a clean driving record to use vehicles requiring Class C License. (i.e. company van and truck)
• Possess or can obtain and maintain a forklift license.

 

Occasional Travel between Abzena sites (Bristol PA, San Diego CA) as needed.  

 

Physical Requirements: 

 

• Shift times and days will change to support manufacturing needs.
• Ability to stand for 2 to 3 hours at a time, or sit for 2 to 3 hours at a time.
• Frequently lift 25 pounds, move objects up to 50 pounds and bulky items.
• Work in both cold rooms and ambient temperatures.
• Stand/walk during entire length of shift.
• Use arms, hands, and fingers to handle, feel or reach.
• Ability to climb at heights of 20 feet, balance, stoop, kneel, crouch, or crawl while wearing PPE.
• Visual abilities including near and far sight, color, peripheral vision, depth and ability to focused on long tasks.

 

FLSA:

• Non-Exempt

 

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.