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Inspection Manufacturing Lead

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Job ID R0039349 Date posted Jun. 17, 2021 Location Round Lake Beach, Illinois

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Job Description

The Inspection Manufacturing Lead is responsible for executing all processes in Inspection while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. He/She is expected to fully participate in both departmental projects and any quality working teams which may be applicable. Under the general direction of the supervisor, this position shall be responsible for the hands on execution of all activities in the production area. In addition to making routine revisions to documents, he/she may rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. He/She has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.

Primary Duties

This role supports the Inspection departments by following the below responsibilities:

  • Supports all local manufacturing operations.

  • Complete relevant paperwork following GDP/GMP guidelines.

  • Participate on Continuous Improvement projects.

  • Oversee receiving and distribution of supplies into the production area as necessary.

  • Ensure daily cleaning of the production area to maintain in GMP fashion.

  • Train and mentor junior level supply handlers and production associates

  • Work with other groups such as maintenance/metrology to ensure preventative maintenance is done.

  • Oversee daily operation with intend to for see and mitigate future obstacles

  • Ensure sound verbal and written communication to cross functional teams if an issue arises

  • Coach employees on procedures and process to allow employees to work independently and make decisions confidently

  • Prioritize daily tasks to ensure production downtime does not occur

  • Understand escalation pathways to receive proper support to prevent production downtime

  • Ability to work and troubleshoot in manufacturing execution system (EBM)

  • Prepare and review batch folders

  • Accountable for meeting production goals and to coach employees for better results

  • Must be willing and able to work 12 hour shift in a 2-2-3 rotation. Shifts are 5am-5:30pm, 5:00pm – 5:30am.

Responsibilities

On production floor overseeing operation, driving results, coaching employees

Continuous Improvement Initiatives, GEMBA Walks, Issue Investigations, Production Preparation

Education and Experience Requirements

  • Requires AA Degree with 2-4 years experience or high school diploma with 4-6 years relating manufacturing experience

Skills and Abilities Wanted

  • Must have good written and verbal communication skills and understanding of cGMP regulations. Good procedural writing skills.

  • Familiarity with pharmaceutical production equipment

  • Must be able to read and follow detailed written instructions.

  • Must be able to apply quantitative analysis to analyze process performance.

  • Good interpersonal skills and be able to work effectively and efficiently in a team environment.

  • This position requires shift, weekend and holiday work.  Overtime may be required at times.

  • The incumbent must work in a clean room environment wearing special garments.  Additionally, personal protective equipment must be worn due to safety requirements.

  • Knowledge of basic chemical and biological safety procedures.

  • May require immunization before performing work within the manufacturing area.

  • Good computer skills

Core Competencies Wanted

  • Engage Others- Be Proactive-

    • Takes the initiative to openly express ideas and concerns.

    •  Establishes credibility and acts responsibly to earn the confidence, trust and respect of others.

    • Recognizes and acknowledges others’ contributions to team success.

  • Collaboration- Cultivate Relationships

    • Proactively assists others in accomplishing work.

    • Builds and maintains productive relationships based on mutual trust and respect.

    • Professionally communicates with all business partners.

  • Drive for Results- Deliver on Commitments

    • Establishes challenging goals and holds self accountable for achieving them. 

    • Effectively manages multiple assignments and competing priorities by maximizing time, being well organized and utilizing available resources.

    • Ensures delivery of accurate and complete work within designated timelines.

  • Strategic Approach- Know the business

    • Understands and follows the Code of Conduct, policies, and procedures relevant to job accountabilities.

    • Effectively demonstrates an understanding of Takeda’s core business in meeting the needs of others.

    • Demonstrates ability to solve problems by analyzing issues and making informed recommendations.

  • Lead Change- Demonstrate Flexibility

    • Adjusts work by organizing and prioritizing tasks in the face of changing business needs.

    • Demonstrates a professional approach in adapting to change.

    • Adapts work products, processes and services in response to changes in the business environment.

  • Self-Awareness- Be Conscientious

    • Listens carefully and is receptive to feedback from others.

    • Demonstrates a willingness to admit one’s mistakes and modify approach to ensure a positive outcome.

    • Demonstrates composure under trying circumstances and approaches problems professionally

  • Develop Capabilities- Take Initiative

    • Actively seeks opportunities for personal growth and development and monitors progress toward achieving development goals.

    • Consistently utilizes available resources to acquire, develop and apply new skills and knowledge.

    • Responds to feedback by capitalizing on strengths and building upon areas of improvement for the benefit of the organization.

Other Job Requirements

  • Must be able to carry up to 25 lbs., lift up to 50 lbs.

  • Must be able to work overtime as required.

  • Must be able to stand and walk for majority of shift

  • Must have 20/20 near and distance vision

  • May not be colorblind

Location and Salary Information: This post excludes CO applicants

Locations

USA - IL - Round Lake - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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