Quality Assurance Manager

3 weeks ago

Forest Park, Georgia, United States Grifols Shared Services North America, Inc Full time
Quality Supervisor II/III Job Description

Grifols Shared Services North America, Inc is seeking a highly skilled Quality Supervisor II/III to join our team. As a Quality Supervisor, you will be responsible for supervising employees engaged in performing various Quality Control (QC) tasks, including laboratory testing, documentation review, investigations, and test release. You will also participate in employee relations matters and be responsible for performance management in your area of responsibility.

Key Responsibilities:
  • Directly supervise employees engaged in various QC related tasks and assign job duties.
  • Ensure compliance with company policies and procedures and optimize the use of staff and technical capabilities within defined areas.
  • Provide technical and non-technical support on quality-related matters.
  • Consult with manufacturing and internal regulatory departments on GXP matters.
  • Follow cGMP and department safety practices.
  • Provide effective leadership to employees in Quality Control.
  • Demonstrate high levels of value and integrity.
  • Consult with QC Sr. Management regarding key decisions.
  • Apply expertise in testing to develop, validate, and troubleshoot analytical methods.
  • Serve as SME for laboratory assays and act as a resource for laboratory staff.
  • Perform investigations and write reports.
  • Author SOPs and other laboratory documents.
  • Collaborate with production and Quality Assurance and Compliance on projects, incident investigations, and annual product reviews.
  • Evaluate data and perform statistical analysis for various projects.
  • Serve as system administrator and SME for various laboratory information systems and applications.
Requirements:
  • Excellent communication skills (written and verbal).
  • Basic knowledge/understanding of domestic and applicable foreign regulatory agency requirements/guidelines.
  • Education and Experience Requirements by Level:
    • Supervisor I, Quality, QC - BA/BS - preferably in a STEM curriculum and 3 yrs of relevant experience or an equivalent combination of education and experience.
    • Supervisor II, Quality, QC - BA/BS - preferably in a STEM curriculum and 5 yrs of relevant experience or an equivalent combination of education and experience.
    • Supervisor III, Quality, QC - BA/BS - preferably in a STEM curriculum and 6 yrs of relevant experience or an equivalent combination of education and experience.
Work Environment:

The work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32*, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Often performs duties standing. Frequently bends and twists neck and waist. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to other facilities. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently interacts with others, relates sensitive information to diverse groups.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.

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