Supervisor, QA - Quality System

Job ID
2021-2767
Category
Quality Assurance & Regulatory Affairs
Location : City
Madison

Job Description

JOB OBJECTIVE: The Supervisor, QA – Quality System supervises team members performing activities for QA document control, record control, and training. Supervisor will ensure training program and document and record programs meet external requirements and business needs.


ESSENTIAL DUTIES:


1. Provides oversight to the quality team members responsible for document control, record control, change control, and QA training functions.


2. Coordinates activities, sets priorities, and drives actions to completion in the document control, record control, change control and QA training functions.

 

3. Reports to management on a regular basis on the compliance and performance of the training and document programs; provides recommendations for improvement.


4. Champions continuous improvement of training program and document and record programs.

 

5. Collaborates with stakeholders to develop content and train employees on the Quality System and processes.


6. Ensures training policies, procedures, systems and records meet external requirements as well as business needs.


7. In conjunction with supervisors and subject matter experts, helps define and deliver quality training in an effective method (e.g. computer-based, on-the -job, classroom, read-and-understand, self-study, etc.).


8. Trains and certifies internal staff as trainers or training leads to develop and deliver training and qualification activities in their local areas. Provides recertification as appropriate.


9. Reviews and approves training materials for quality, consistency, and effectiveness.

 

10. Ensures new or modified training materials or practices are communicated to departments and/or individuals affected by these changes and ensures appropriate involvement and communication.

 

11. Leads or participates in department/company projects in a positive team environment.

 

12. Works independently with minimal direct supervision and completes tasks as assigned, with frequent changes to priorities and workload.

 

13. Translates strategy and priorities into action and focus.

 

14. Makes decisions and exercise regular judgement in daily tasks, and effectively articulate interpersonal issues and resolve conflict in a constructive manner.

 

15. Understands and complies with ethical, legal and regulatory requirements applicable to our business.


OCCASIONAL DUTIES:

1. Maintains documents and records for the training program and document and record programs. Documents and records include:
• Standard Operating Procedures
• Forms
• Record Retention Policy
• Training plans
• Course descriptions
• Course content
• Attendance records
• Certificates, attendance sheets, and other required supporting documentation


2. Keeps current with adult learning theory and practice.


3. Coordinates and schedules training events.


4. Develops and delivers training.


5. Works with management to develop budget and resource needs.


MANDATORY QUALIFICATIONS:


1. BS or BA degree in adult education, life science, engineering, or other field or equivalent work experience.


2. 5+ years of experience in GxP regulated environment.


3. Experience in document control or training program, preferably in a supervisory role.


4. Exceptional written and oral communication skills. Excellent skills in presentation and providing training content to adults with various backgrounds and needs.


5. Excellent organizational understanding and ability to work with managers to understand business needs and provide necessary training programs.


6. Ability to organize, manage, and complete multiple projects concurrently.


PREFERRED QUALIFICATIONS:


1. Professional certifications such as CPLP or ASTD.


2. Teaching experience or education in technical, manufacturing, biotech or scientific field.


3. Experience in legal requirements and records maintenance within a regulated industry.


4. Familiar with eQMS and training software systems.


PHYSICAL REQUIREMENTS:


1. Ability to use computers and computer peripherals for an extended period of time.


2. Ability to lift up to 30 lb. occasionally.

 


Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.

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