Supervisor, QA – Quality System

at Promega
Location Fitchburg, WI
Date Posted July 6, 2021
Category Bioscience
Job Type Full-time
Address 2800 Woods Hollow Rd

Description

Job Description

Promega is an international bio-tech company with over 4000 high quality products that have been supporting science for over 40 years. We support scientists researching life and disease, pharma companies developing new treatments, forensic labs matching DNA from crime scenes and clinical labs running and confirming health tests - and that’s just the beginning. And yes, we have been extremely busy providing our technologies to support COVID-19 testing and research.

We strive to create an open, inviting and inclusive culture – we care about you as a person, not just a team member. We embrace the principles of emotional and social intelligence – which helps our employees improve relationships, manage stress and enhance connections. Establishing and maintaining relationships is part of the foundation of our culture - teams are more like family than co-workers.

Our campus speaks volumes. Headquartered in Madison, employees work in and around a campus with multiple buildings that are integrated into a natural setting with trails, ponds, woods and a restored prairie. Sustainability is important – we invest in energy efficiency and use renewable energy. Our culinary team offers top notch food to employees – including an onsite garden to supply fresh produce. Check out our campus through this map, and learn more about the our people and sustainable practices.

 

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.

 

Click here to learn more & apply today!