Sr. QA Manager

3 weeks ago

Decatur, United States Unizon Technology LLC Full time
Job DescriptionJob Description

Essential Duties & Responsibilities:

  • Responsible for the overall direction, coordination, and evaluation of the Document Control and Training departments.
  • Lead and assist with maintaining the electronic Document Management System (DMS).
  • Lead and assist with maintaining the electronic Learning Management System (LMS) for training.
  • Maintain training curricula for positions at the site.
  • Responsible for organizing and archiving cGMP documents on site.
  • Compile and report metrics for Quality Assurance Documentation and Training.
  • Evaluates quality processes for alignment with cGMPs and evolving regulatory expectations.
  • Assist with investigations and review/approve as needed.
  • Review all controlled documents through Document Change Request (DCR) process.
  • Implements and enforces systems, policies, and procedures.
  • Assist HR with the creation and delivery of New Hire Orientation (NHO).
  • Assist with audits, both internal and external.

Additional Responsibilities:

  • Responsible for performance reviews, goal setting, and personnel development plans for Supervisor, QA Documentation Systems and QA Technicians - Documentation Providing regular performance feedback (praise and developmental) to members of QA Quality Operations team.
  • Assists in recruiting, interviewing, and hiring qualified employees to fill open positions.
  • Addressing complaints and resolving personnel problems within the department(s).
  • Maintaining confidentiality of information.


Education and Experience:

  • Bachelor's Degree from a four-year accredited college or university with Major in a science related field.
  • Minimum of five years of cGMP quality assurance experience in biotechnology, pharmaceutical, or medical device industry. Working knowledge, writing, and following of SOPs; document management and control system processes.
  • Mental Requirements
  • Effective written and oral communication skills;
  • Strong organizational, planning, and communication skills;
  • Ability to apply deductive reasoning and analytical thoughts to understand complicated issues;
  • Demonstrates exceptional time management skills;
  • Ability to work in an independent manner, as well as a group environment;
  • Ability to multi-task, set priorities, meet deadlines and effectively deal with a high level of office stress;
  • and Ability to maintain confidentiality of work assignments and personnel issues.

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