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Quality Assurance Specialist - Quality Systems

Quality Assurance Specialist – Quality Systems

 

 

 

The QA Specialist – Quality Systems is responsible for supporting quality system elements to assure compliance with FDA cGMP and other quality standards, with responsibilities associated in areas such as: Annual Product Reviews, Change Controls, Product Labeling Changes, Tracking and Trending of Quality Data, Training, Supplier Quality Management, as well as internal and external audits. The QA Specialist – Quality Systems will also support regulatory inspections.

An individual in this position will be assigned position responsibilities in support of one or more functional areas and based on departmental needs.

EDUCATION AND EXPERIENCE

  • Bachelor’s degree required; Degree in Biology, Chemistry or related field of study preferred
  • 3 – 5 years of experience in a FDA regulated pharmaceutical facility preferred
  • 3 – 5 years of experience in Quality Assurance / Quality Systems

TECHNICAL SKILLS REQUIREMENTS

  • Must demonstrate excellent attention to detail, time management, team participation, and organizational skills.
  • Must be able to follow standard operating procedures and safety documents.
  • Proficient in the use of MS Office tools (Word, Excel, Outlook).
  • Good verbal, written, and electronic communication skills.
  • Ability to collaborate with other departments.

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to sit; climb or balance, stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. The employee must meet visual acuity requirements including color, depth perception, and field of vision.

POSITION RESPONSIBILITIES

Assure compliance with applicable FDA cGMPs – 21 CFR 210/211, 21 CFR 225, and 21 CFR 226

This position, will be assigned tasks, as needed, related to the following:

  • Provide quality oversight for the creation and revision of labeling components, including participation on the Label Review Team.
  • Compile data and write Annual Product Reviews.
  • Support of the Change Control Process, including participation on the Change Control Review Board.
  • Support training program, including New Employee Orientation Program and annual GMP training schedule.
  • Provide necessary documentation to Huvepharma Regulatory Affairs, as requested (i.e., in support of MCSRs).
  • Review regulatory filings and submissions, as requested.
  • Support site Data Integrity requirements.
  • Provide metrics for Quality Review Board, as requested.
  • Provide support during HACCP, FDA and other inspections.
  • Support Supplier Qualification Program.
  • Support updates to the Approved Vendor/Supplier list.
  • Perform Internal and External Audits per annual audit schedules.
  • Perform other quality system duties as required to support FDA cGMP compliance such as other quality projects and manufacturing site initiatives.

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