Supervisor, Quality System Software

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 our people and sustainable practices.

 

JOB OBJECTIVE: Leads and supervises a team in the development, enhancement, support, and maintenance of Promega’s eQMS software and its applications. Prioritizes and distributes workload on software issues, enhancements, and projects among the team in a way that encourages high-quality results and business success.

ESSENTIAL DUTIES:

1. Ensure that the eQMS and related documentation meets internal requirements and complies with external requirements including 21 CFR and ISO requirements.

2. Assure new or revised eQMS modules meet their design requirements and performance requirements through oversight or participating in their development or testing.

3. Establish and implement methods to prioritize eQMS work to meet user and business needs.

4. Direct and oversee QA Software employees including:

o Assign and monitor the work of QA Software staff to support business needs.
o Provide direction to staff and resource allocation as needed.
o Ensure that records are produced and maintained according to procedural requirements.
o Ensure daily support is provided to eQMS users.

5. Provide coaching, career development and feedback on performance to staff.

6. Represent QA on cross-functional teams and in interactions with other departments.

7. Work with QA management to develop departmental staffing, budget, training, and capital expense plans annually or as necessary.

8. Lead or participate in department/company projects in a positive team environment.

9. Work independently with minimal direct supervision and complete tasks as assigned, with frequent changes to priorities and workload.

10. Translate strategy and priorities into action and focus.

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

12. Understand and comply with ethical, legal, and regulatory requirements applicable to our business.

OCCASIONAL DUTIES:

1. Identify and lead improvement projects.

2. Provide support, including representing Promega, during external inspections and audits.

3. Represent Promega in discussions/interactions with external suppliers and service providers.

4. Present updates or training on projects/programs as needed.

5. Organize, facilitate, or lead cross departmental projects.

MANDATORY QUALIFICATIONS:

1. Position requires a B.S. or M.S., Computer Science/Engineering or related field strongly preferred.

2. 5+ years’ experience in a software development or software quality assurance position.

3. Demonstrated experience in achieving results in a cross functional environment.

4. Advanced communication skills, both verbal and written.

5. Independent self-starter with proven analysis planning, leadership, and project management skills.

PREFERRED QUALIFICATIONS:

1. 5+ years in cGMP environment and a strong understanding of ISO13485 and QSR Quality System requirements.

2. Project Management, such as PMP, certification.

PHYSICAL REQUIREMENTS:

1. Ability to work with computers.

2. Ability to lift 20 lbs.

 

Click here to learn more & apply today!