Quality Assurance Compliance Specialist IV

Job description

Overview

 

GENERAL SUMMARY OF POSITION:

 

The QA Compliance Specialist IV is responsible for ensuring that quality standards are met in a cGMP Biologics Manufacturing facility by performing a wide variety of activities to assure compliance with applicable regulatory requirements. These activities include, but are not limited to: conducting audits, designing and executing programs, data and documentation reviews and analysis

Responsibilities

MAJOR RESPONSIBILITIES:

 

  • Facilitate the review and approval of deviation reports; ensures appropriate corrective actions are assigned.
  • May be responsible for managing the development, implementation and maintenance of Quality Assurance Training systems and activities. Assures training is conducted and documented per GMP requirements. 
  • Develops and manages GMP orientation program and ongoing GMP training for all GMP related departments.
  • Processes change controls for closure; ensures required tasks are completed.
  • Plans and conducts audits of co-manufacturers and vendors
  • Plans and conducts periodic internal audits of production and laboratory areas.  Writes audit reports.
  • Reviews completed batch records, related records, and validation packages for compliance to cGMPs and internal requirements.   Reviews and approves SOPs, in-process forms, and validation protocols.
  • Reviews audit findings and completion of corrective actions.  Provides periodic reports to management regarding status of audits and corrective actions.
  • Prepares annual product reports.
  • Applies knowledge and understanding of current regulations to make recommendations to senior staff.
  • Performs additional job related duties as required
Qualifications

REQUIRED QUALIFICATIONS:

 

  • Requires BS degree in a scientific discipline or equivalent and a minimum of 8 years relevant experience or equivalent
  • Prior experience in a cGMP regulated environment. Strong working knowledge of GMPs and Quality systems, and thorough understanding of how cGMP regulations and guidances apply to investigational and market licensed biologics
  • Demonstrated ability to train and supervise others
  • Ability to conduct complex troubleshooting
  • Ability to assess issues and make Quality decisions of a moderate scope within established procedures and policies.
  • Working knowledge of current Good Manufacturing Practices and Quality Assurance systems
  • Must possess the ability to interpret and apply current GMP regulations and internal Quality policies consistently.
  • Computer literate and knowledge of WordPerfect or MS Word, and Lotus or Excel.  Demonstrated skills in developing and organizing systems for management of information. 
  • Demonstrated ability to meet deadlines, multitask, and change priorities while maintaining productivity.
  • Ability to work well independently and in a team environment
  • Demonstrated excellent verbal and written communication skills
Additional Information

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Job No:
Posted: 4/4/2021
Application Due: 4/2/2022
Work Type: Full Time
Salary: