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Quality Control Manager/ Quality Supervisor

In Illinois / United States

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Quality Control Manager/ Quality Supervisor   

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JOB TITLE:
Quality Control Manager/ Quality Supervisor
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
Elgin, Illinois / United States

JOB DESCRIPTION :

Responsibilities

  • Provides leadership, direction, and work hands-on in performing Quality functions including Incoming Inspection & Release, In-Process QA, Label Control, and Material Disposition.
  • Monitors day-to-day manufacturing activities to assure production processes are in compliance with and followed as per the FDA guidelines, written standard operating procedures, and company policies
  • Supervisory oversight of the quality team.
  • Ensures raw materials used in the production of products are from qualified/approved vendors and meet internal quality testing specifications.
  • Advises other departments about quality assurance issues that impact their realm of responsibility.
  • All phases of documentation review and approval, including the creation of standard operating procedures for the Quality Assurance Department.
  • Administers the Hydrox Investigation/CAPA program including final approval of all reports.
  • Performs data analysis investigation of trends for root cause analysis, creating corrective/preventive actions, and ensuring the effectiveness of the actions for products.
  • Creates standard operating procedures to ensure quality assurance compliance with current good manufacturing practices.
  • Seek efficiency improvements in productivity and quality without compromising the FDA regulatory and compliance standards.
  • Immediately communicate to management any issues or problems potentially impacting products, processes, and/or any activities for the organization.
  • Interface with other departments to ensure information is communicated to these department heads concerning quality matters in a timely and complete fashion.
  • Participates in audits conducted by regulatory agencies and consultants.
  • Assists the VP of Quality in developing and implementing systems, evaluating procedures, plans and policies to ensure product integrity and compliance with the current FDA guidance.


Requirements

  • B.S. / B.A. in Science-related discipline with experience in a pharmaceutical/Food manufacturing organization.
  • Thorough understanding of FDA cGMP regulations and experience in handling Regulatory inspections.
  • Knowledge of pharmaceutical formulation and manufacturing processes.
  • Minimum of 3years of supervisory or management experience in pharmaceutical/Food quality assurance.
  • Versed in the regulatory requirements (cGMP) of the pharmaceutical industry, and will have demonstrated strength in problem solving and resolution.
  • Must have proven interpersonal skills, and be able to direct the activities of subordinates.
  • Able to perform statistical analysis in developing test levels and in performing investigations. Knowledge of Six Sigma Green Belt and lean tools.
  • Excellent problem-solving aptitude, communication, and multi-tasking skills.
  • Excellent verbal and written communication skills.


Benefits

Medical, Dental, Vision, 401(k), Holiday pay, Vacation, PTO, Short Term Disability, Long Term Disability, and Life Insurance.

Position Details

May 23, 2021
S1620313884601696
Illinois / United States
Elgin,
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Quality Control Manager/ Quality Supervisor    Apply

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Responsibilities

  • Provides leadership, direction, and work hands-on in performing Quality functions including Incoming Inspection & Release, In-Process QA, Label Control, and Material Disposition.
  • Monitors day-to-day manufacturing activities to assure production processes are in compliance with and followed as per the FDA guidelines, written standard operating procedures, and company policies
  • Supervisory oversight of the quality team.
  • Ensures raw materials used in the production of products are from qualified/approved vendors and meet internal quality testing specifications.
  • Advises other departments about quality assurance issues that impact their realm of responsibility.
  • All phases of documentation review and approval, including the creation of standard operating procedures for the Quality Assurance Department.
  • Administers the Hydrox Investigation/CAPA program including final approval of all reports.
  • Performs data analysis investigation of trends for root cause analysis, creating corrective/preventive actions, and ensuring the effectiveness of the actions for products.
  • Creates standard operating procedures to ensure quality assurance compliance with current good manufacturing practices.
  • Seek efficiency improvements in productivity and quality without compromising the FDA regulatory and compliance standards.
  • Immediately communicate to management any issues or problems potentially impacting products, processes, and/or any activities for the organization.
  • Interface with other departments to ensure information is communicated to these department heads concerning quality matters in a timely and complete fashion.
  • Participates in audits conducted by regulatory agencies and consultants.
  • Assists the VP of Quality in developing and implementing systems, evaluating procedures, plans and policies to ensure product integrity and compliance with the current FDA guidance.


Requirements

  • B.S. / B.A. in Science-related discipline with experience in a pharmaceutical/Food manufacturing organization.
  • Thorough understanding of FDA cGMP regulations and experience in handling Regulatory inspections.
  • Knowledge of pharmaceutical formulation and manufacturing processes.
  • Minimum of 3years of supervisory or management experience in pharmaceutical/Food quality assurance.
  • Versed in the regulatory requirements (cGMP) of the pharmaceutical industry, and will have demonstrated strength in problem solving and resolution.
  • Must have proven interpersonal skills, and be able to direct the activities of subordinates.
  • Able to perform statistical analysis in developing test levels and in performing investigations. Knowledge of Six Sigma Green Belt and lean tools.
  • Excellent problem-solving aptitude, communication, and multi-tasking skills.
  • Excellent verbal and written communication skills.


Benefits

Medical, Dental, Vision, 401(k), Holiday pay, Vacation, PTO, Short Term Disability, Long Term Disability, and Life Insurance.