Quality Control Supervisor, Microbology

US-GA-Union City
Job ID
2017-1082
Category
Quality Control
Shift
Union City - QC Microbiology - Wednesday, Thursday & Friday 6PM to 6AM

Overview

The Quality Control Supervisor is responsible for the providing daily supervision of lab operations (people, process, product) for one or more functional areas within Quality Control. Ensures the site, process, product, and personnel are compliant with regulatory requirements.

Responsibilities

  • Provides daily supervision of operations for one or more functional area within Quality Control.
  • Supervises security, maintenance and operational use of laboratory equipment.
  • May be responsible for one or more of the following:
  • Raw materials qualification program
  • Environmental monitoring program
  • In-process and final product testing of products
  • May participate in the development of standards, methods and procedures for inspecting, testing and evaluating the quality of products.  
  • Conducts and manages laboratory investigations and relevant exception reports. Makes recommendations for corrective action, and implements as needed, to ensure conformity with quality specifications.
  • Ensures finished products conform to company standards and satisfy GMP regulations.
  • Represents QC in cross-functional teams, projects and GXP-related problem resolution.
  • Selects, develops and evaluates personnel to ensure functional objectives are met. Performs ongoing assessment of development and training needs of reporting staff to ensure continue development of personnel.
  • Accountable for adherence to department budget.
  • Receives assignments in the form of objectives with goals/measures predefined. Provides guidance to employees according to established policies and management directives. Work is reviewed by management to measure meeting of objectives. Administers company policies that directly affect staff members. Recommends changes to area policies.
  • Works on problems of moderate scope in which analysis of situation or data requires review of identifiable factors. Exercises independent technically sound judgment within defined procedures and policies to determine appropriate action. Acts as advisor to area staff, and becomes actively involved as required to meet schedules or resolve problems.
  • Erroneous decisions or failure to achieve results will cause delays in schedules.
  • Frequently interacts with direct reports, outside customers and functional peer groups at various management levels. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects/schedules, etc.
  • Provides immediate supervision or assigns tasks to a unit or group of employees. Provides general or direct supervision to exempt employees and/or skilled nonexempt employees. A portion if the time may be spent performing individual tasks.

 

 

Qualifications

  • Bachelor’s degree in a scientific discipline or equivalent.
  • Minimally 6+ years of experience years related experience in cGMP/FDA regulated industry.
  • Typically 3+ years in a leadership role.
  • Thorough knowledge of cGMP/QSR/ICH/FDA regulations.
  • Experience with inspections/audits by the FDA and other regulatory agencies.
  • Ability to independently prioritize and successfully manage complex and competing projects.
  • Proficient in MS Office applications and MS Project.
  • Strong troubleshooting and problem solving skills.
  • Strong team leadership and staff development skills.
  • Excellent oral and written communication skills.

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