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Quality Control Supervisor

Company: ANI Pharmaceuticals, Inc.
Location: Baudette
Posted on: May 27, 2023

Job Description:

Position Summary This position is responsible for managing and directing, a professional group of analysts engaged in physical and chemical testing of raw materials, packaging components, in-process materials, and finished drug products to determine conformance with specifications. - This position is responsible for day to day scheduling of analyst responsibilities to ensure production needs are being met and that the laboratory is in conformance with cGMPs. - Additional responsibilities include conducting and writing laboratory investigations, notifying Quality Assurance of potential product quality issues, coordinating contract lab testing, revising SOP's, IOP's and other laboratory related documents. - Lastly, this individual enforces company policies and directives that apply to the department. - - Position Accountabilities

  • 30% - - - - Manage and direct a group of analysts effectively so company goals and objectives are met, provide input on resources availability and needs to support production and project plans/sales goals, and coordinates work schedules with other departments. - Develops plans and timelines to assure analytical support. - Assures effective and efficient utilization of resources. - Establishes work priorities and expectations. - Delegates authority and responsibility for the accomplishment of planned work. - Provides direction and feedback for timely work accomplishment. - Manages external laboratory resources to handle overflow laboratory support.
  • 25% - - - - Provides training and enforces policies and procedures. - Assures systems and procedures are adequate by developing, reviewing, and approving procedures to assure compliance with governing regulations, filed applications, and quality standards. - Identifies deficiencies and implements corrective actions. - Provides technical expertise to support investigations, protocols and procedures outside the laboratory. - Monitors training, performance and development of professional staff and provides feedback.
  • 25% - - - - Performs reviews of data collected under approved test methods, investigational plans, and protocols in accordance with governing SOP's. - Approves all analytical data and results and releases to Quality Assurance.Work with analysts to correct deficiencies, mentor to assure understanding.
  • 20% - - - - Notifies Quality Assurance in the event of a potential product quality issues and conducts and writes laboratory investigations. - Ensures timely implementation and closures of CAPAs. - - Job Specifications - - - - Core Competencies
    • Communication
    • Continuous Learning
    • Customer Service Orientation
    • Decision Making
    • Integrity
    • Leadership
    • Strategic Thinking - - - - - -Functional Competencies
        • Coaching, Consulting and Developing Others
        • Data Affinity
        • Project and Process Management
        • Quality Standards and Best Practices - - - - - - -Minimum Education
          • Bachelor's Degree in Chemistry, Microbiology, or related field.
          • Education, training, or certification in Management and Leadership - - - - - - -Minimum Experience
            • 1 year experience in a leadership role in an analytical laboratory in the pharmaceutical industry.
            • 4 years of -experience in an FDA regulated laboratory in the pharmaceutical industry RELOCATION TO BAUDETTE, MINESOTA AT TIME OF HIRE IS REQUIRED - - - - - - - -Minimum Field-of-Expertise
                • Ability to follow, prepare and explain technical matters and procedures.
                • Ability to make decisions independently after appropriate input from areas that will be affected.
                • Ability to manage multiple projects and competing priorities.
                • Ability to perform under stressful situations
                • Demonstrated expertise of Laboratory cGMPs
                • Excellent leadership, communication, and interpersonal skills. - - - - - - -Preferred Education
                  • Advanced education in Management or Business Administration.
                  • Post graduate degree in Analytical Chemistry, or other relevant area. - - - - - - -Preferred Experience
                      • 3+ years within the Baudette QC Organization.
                      • 5 years ofexperience in an analytical laboratory in the pharmaceutical industry.

Keywords: ANI Pharmaceuticals, Inc., Fargo , Quality Control Supervisor, Other , Baudette, North Dakota

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