Group Leader, Operations

HIKMABedford, OH
Onsite

About The Position

We are seeking a talented and motivated Operations Group Leader. In this role, you will be responsible for providing support to Manufacturing under the general direction of Operations Management. This role provides the necessary leadership to achieve product quality, cost control, cGMP compliance, safety, and the execution of the production schedule to support the customer service requirements.

Requirements

  • High School diploma or equivalent is required.
  • Minimum: Five [5] years’ experience in a non GMP environment; or two [2] years’ experience within a GMP manufacturing environment.
  • Strong interpersonal skills and be an excellent communicator who can successfully interact and coordinate activities across departmental boundaries and at varying levels within the organization.
  • Excellent writing skills are essential. Must be able to document process issues in a clean, concise manner in accordance with cGMPs and SOPs.
  • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
  • Able to perform mathematical calculations associated with production documentation analysis and problem solving.
  • Technically oriented with ability to analyze problems and suggest solutions.
  • Ability and working knowledge of how to use a computer.
  • Has demonstrated leadership skills or has shown potential leadership abilities in his/her work.
  • The duties of this job involve walking, lifting (up to 40 lbs.), bending, and sitting. Majority of the time is spent in the performance of manual inspection, paperwork and coordination of line activities.
  • Good visual acuity with or without eyeglasses/contacts (eye exam required).

Nice To Haves

  • Prior aseptic technique training and working in a clean room environment.
  • Knowledgeable in site training management systems is preferred.
  • Knowledgeable in site label verification vision systems is preferred.
  • Knowledgeable in line management data capture systems is preferred.

Responsibilities

  • Regular and predictable onsite attendance and punctuality.
  • Adheres to all environmental, health and safety SOPs, policies and procedures, including any department specific requirements.
  • Coordinates and oversees daily activities of hourly production staff providing leadership assistance and necessary coaching.
  • Initiates and completes investigative reports for production related process deviations.
  • Provides phase-in training for new and existing employees.
  • Provides conflict resolution and handles general problems/requests when necessary.
  • Coordinates all functions and lead efforts related to Filling, Inspection and/or Packaging based on assigned department.
  • Evaluates/enforces current practices within areas of responsibility.
  • Coordinates orders for production related materials.
  • Provides problem investigation and resolution.
  • Supports management and engineering projects as assigned.
  • Maintains training records for individual departments and production areas.
  • May create and run reports tracking line performance.

Benefits

  • Compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors.
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