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Quality Systems Lead

Quality Systems

POSITION:

Quality Systems Lead

DEPARTMENT:

Quality Systems (QS)

REPORTS TO:

Quality Systems (QS) Supervisor

SUPERVISES:

Quality Inspectors

Implementation date

09/02/2020

 

 

 

summary / objective
The Quality Systems Lead is responsible for leading the day to day activities in the Quality Inspection group.  The Quality Systems Lead may also serve as the stand in approver when the Quality Systems (QS) Supervisor is out of the office.  The Quality Systems Lead will delegate with guidance from the supervisor or when necessary complete the following task related activities listed below:

 

essential functions

  1. Adhere with SOPs and regulatory requirements such as GMPs, GDPs, GLPs and OSHA regulations
  2. Direct training as the subject matter expert of all training modules and assist in maintaining training documents
  3. Update the Quality Systems (QS) Supervisor and the Associate Director of Quality Systems / Microbiology, QA and other plant management on Quality Inspection related activities
  4. Revise or review the following Plant controlled documents to ensure they are current and in compliance:
    • SOP’s, forms, and logbooks,
    • Specifications
    • Change Controls
  5. Approve / review associated batch records and logbooks
  6. Leads and directs the work of others; Communicates daily with department members
  7. Keeps current with regulations, cGMP’s and company procedures and ensures compliance
  8. Conducts investigations where necessary
  9. Quality Inspection
    • Leads Inspection personnel in daily responsibility and production coverage
    • Performs daily reviews of the inspector in their assigned work areas to ensure compliance with cGMP’s, DEA and company SOPs
    • Ensure timely inspection, sign in and reconciliation of production rooms, equipment, raw materials and packaging components by inspection and label control personnel to ensure production schedules are maintained
  10. Contributes to the team by:
    • Assisting other departments when necessary
    • Communicating with all employees at all levels
    • Providing pertinent information to complete a given task correctly
    • Ensuring all personnel comply with cGMP and company procedures
    • Participate in continuous improvement initiatives.
  11. Performs other tasks as deemed necessary by the department head

 

work environment

This job operates in a professional office environment and business casual attire with closed toe shoes and socks is required.  This role routinely uses standard office equipment such as computers, phones, photocopiers and fax machines.  This role requires Good Hygiene and facial hair must be neat and tight and kept well-trimmed to prevent incidental contamination of product.  Working with Biohazardous materials is also prominent.

 

 

 

physical demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  The employee may be required to sit at a computer or be on your feet for long periods of time.  Specific vision abilities required by this position.   This job requires the need to be able to lift up to fifty (50) pounds.

 

position type/expected hours of work
This is a full-time position.  Days and hours of work are Monday through Friday but extended (earlier or later) work times or weekend work may be required when the production needs exist.  The exact shift hours may vary depending on business needs.

 

travel

N/A

 

required education and experience

High School Diploma preferred but equivalent experience required

 

preferred education and experience

  • Five (5) to ten (10) years of experience in pharmaceutical
  • Knowledge of cGMP/GLP/GDP, USP / EU regulatory requirements
  • Excellent project management and organizational skills
  • Excellent interpersonal communication
  • Qualified to work with controlled substances 
  • Experience with regulatory audits

Location - Quality Systems

 
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