Governance Risk Compliance (grc) Engineer

About MasterControl:

MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers to bring life-changing products to more people sooner. The MasterControl Platform helps organizations digitize, automate and connect quality and compliance processes across the regulated product development life cycle. Over 1,000 companies worldwide rely on MasterControl solutions to achieve new levels of operational excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and postmarket surveillance. For more information, visit www.mastercontrol.com.

JOB SUMMARY:

The Compliance Engineer is responsible for the implementation, maintenance, and success of all compliance activities within the MasterControl organization through the administration of policies and procedures. This role safeguards the quality standards set for the organization by conducting both internal and external quality audits, managing vendors/suppliers, sub-system document control administration, participating in management review, and facilitating effective training.  The Compliance Engineer participates in improvement initiatives such as quality events, deviations, complaints, and CAPAs.

Additionally, the Compliance Engineer is responsible for ensuring the internal and customer-facing validation products for the MasterControl software are in compliance with quality standards.  This includes reviewing and approving completed validation product test results and evidence.

The Compliance Engineer must have excellent analytical and communication skills to properly plan, execute, and administer these duties. The Compliance Engineer is directly involved in the administration of the full integrated management system.

As MasterControl produces QMS software for companies in the Life Sciences and other regulated industries, MasterControl uses its own software to administer its internal integrated management system. This system is audited frequently by clients, notified bodies (ISO), and regulatory entities (such as the FDA).

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Ensure compliance with all quality documentation within the organization by partnering with department managers to write SOPs, Work Instructions, and other quality documents for their standardized processes and by initiating/revising, collaborating, updating, approving, and routing internal procedures.
• Liaising between internal departments to ensure quality standards are met and provide suggestions for improvement of quality and best practices.
• Participate in facilitation of the electronic employee training system.
• Support customers in completing quality audit questionnaires.
• Schedule and conduct/host customer, prospect, and regulatory compliance and quality audits of MasterControl Solutions, Inc. and provide audit feedback to management.
• Participate in and conduct internal audits and submit compliance and quality audit reports to management.
• Provide reporting for any potential non-compliance areas and include potential recommendations or root-cause analysis.
• Participate in local and cross-sectional improvement activities.
• Sub-system administration duties within the MasterControl electronic QMS software.
• Assist with quality processes (CAPA, Deviation, Training, Audits, Supplier Management, etc.).
• Participate in maintaining a risk-based integrated management system.
• Review of MasterControl software validation documentation.
• Troubleshoot validation acivity issues and provide regulatory level justification documentation.
• Provide training for new Compliance department employees regarding software validation activities, as well as other QMS functions.
• Enhance compliance and quality across the organization and provide stable performance to customers.
• Assist with Compliance department projects and company initiatives.
• Other duties as assigned by management.

PHYSICAL DEMANDS AND WORKING CONDITIONS

• Ability to operate a computer keyboard and mouse at a desk for extended periods of time.
• Communicate effectively in writing, in person, over the telephone and in e-mail.
• Ability to work well with people.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Strong communication and technical writing skills.
• Professional demeanor and positive attitude.
• The ability to work with a team but be self-motivated and willing to adjust priorities where needed.
• Demonstrate integrity and accountability as the integrated management system is under constant scrutiny.
• Experienced with Microsoft Office Suite (Word, Excel, Outlook, etc.) is required.
• Regulatory validation creation/documentation and execution experience.
• High level of accuracy and attention to detail.
• The ability to quickly learn new software applications.
• Experience with MasterControl QMS Software is preferred.
• Experience with Quality Management Systems (i.e., ISO 9001 and ISO 27001).
• Experience with FedRamp, SOC-2, or other similar certifications is preferred.
• Minimum of 2 years’ experience with relevant work in the Life Science industry.

EDUCATION AND TRAINING:

Bachelor’s Degree in Communication, Life Sciences, Regulatory Sciences (or equivalent degree or experience) is preferred.