ProcessPro is proactive in recruiting and retaining the most qualified professionals by offering challenging opportunities to grow both professionally and personally. As a leader in the ERP software industry we believe in combining innovation, business acumen, and top notch customer service for our clients nationwide – and we’re equally committed to our staff. It's everything we do from developing, selling, implementing and supporting software – our staff becomes experts in process manufacturing.
Join our team and surround yourself with talented, motivated people who relish in a dynamic and challenging environment where they are able to learn, contribute, and make a meaningful difference to our clients.
ProcessPro, along with their parent company Open Systems, Inc., offers a full range of comprehensive benefits, including Medical/Dental/Life Insurance and 401(k). If you are interested in growing your skills in a team-oriented organization, we invite you to explore this excellent opportunity to become part of the Open Systems family.
Compliance Specialist (Quality Manager)
Full-time opportunity in St. Cloud, MN!
Open Systems, Inc. is a privately owned, rapidly growing leader in the business software solutions industry. Our success is built on three principles; strong customer focus, sense of urgency and continuous improvement which continues to inspire everything we do. We don’t just sell, implement and support robust ERP software – our team is made up of industry and product experts ready to use our adaptable solutions to solve our customer’s complex business problems and streamline their operations. By combining traditional ERP functions with innovative products and services we deliver ERP solutions that are adaptable and provide total visibility of critical business functions including sales, operations and finance. As an employee, you will enjoy the stability of an established company celebrating over 40 years in business, cutting-edge tools and products, and a friendly and stimulating office environment with opportunities to learn and grow alongside accomplished business leaders.
ProcessPro, a division of Open Systems, Inc. is seeking a Compliance Specialist (Quality Manager) to join our team. In this role, you will work with current and prospective customers focusing on their regulatory needs and documenting best practices of using Open Systems products to adhere to those compliance needs. Primary duties will include staying up-to-date on regulatory changes with a focus on FDA regulated environments, technical writing, and gap analysis for increased penetration into near-vertical markets.
Regulatory Compliance, Validation and Certifications
- Manage and regularly update compliance documents in support of each software release and as regulations change in the vertical markets including; Food and Beverage, Dietary Supplement, Pharmaceutical and Medical Device
- Manage and update documentation and support of Computer Software Validation
- Manage and update certification documentation and manage ongoing compliance to a number of certifications including but not limited to; Safe Quality Food (SQF), British Retail Consortium (BRC) and, National Sanitation Foundation (NSF)
- Provide internal resource support during the implementation process pertaining to FDA validation, as needed.
- Review, update or develop documentation for systems existing compliance features
- Review, update or develop internal supporting documentation for assisting Services teams’ with end-user guidance and best practices for adherence to each regulatory body
- Review, update or develop materials for performing the Mock Recall process
- Perform ongoing research to stay abreast of potential regulatory changes and communicate current and future software enhancements needs.
- Establish gaps in current software relative to existing and future regulations including, but not limited to; 21 CFR, FDA Drug Supply Chain Security Act (DQSA and DSCSA), and FSMA.
- Bachelor’s degree in Food Science, Biology or related field and/or the equivalent experience.
- 3+ years’ experience in an FDA/ISO regulated environment
- Experience working and supporting quality compliance in an FDA-regulated manufacturing environment
- Proficient in research and technical writing
- Experience interpreting subjective and complex aspects of specific regulations and thorough understanding of multiple sets of associated regulations
- Experience analyzing complex issues and formulating clear approaches to resolving/addressing issues
- Demonstrated ability to exercise independent judgment and discretion within a broadly defined range of policies and practices
- Experience with ERP software
- Experience with FDA regulations
- Knowledge of the Software Development Life Cycle
Open Systems, Inc. offers competitive compensation and a comprehensive benefits package including;
- Group insurance; medical, dental and life plan options each with immediate eligibility
- Income security plans; short and long-term disability
- Nine paid holidays each year
- Paid time off; more than three weeks your first year with milestone increases
- Flexible spending accounts; medical and dependent care options
- 401(k) with company match
- Excellent career advancement opportunities
- Tuition reimbursement
If you thrive in a fast paced, customer focused environment where you are challenged to look for ways to improve an existing product or process, you’ll be in good company! Please apply online or send resumes and salary requirements to Open Systems, Inc. Attn: HR, 4301 Dean Lakes Boulevard, Shakopee, MN 55379.