EHS Specialist - Maplewood, MN

Pace Life Sciences

Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations.

SUMMARY:

Responsible for providing or overseeing the analysis, administration, and oversight of broad regulatory policies, programs, and practices; provides feedback and guidance to employees and management, using very complex to specialized professional and technical knowledge of regulatory or related equipment, testing, and procedures.

ESSENTIAL FUNCTIONS:

• Serves as a lead to staff to include providing work direction, guidance, and training.
• Overseeing or reviewing, completing, and processing broad regulatory forms, documents, databases, and related materials and information.
• Provides very complex to specialized analysis, interpretation, and counsel to staff, management, and functional leaders regarding regulatory policies, programs, and practices; involves broad operations and leading implementation and change.
• Provides broad research, feedback, and decisions to resolve management and employee questions and requirements; assists with receiving customer feedback and coordinating resources and responses as required.
• Analyzes and reviews very complex to specialized operations, results, feedback, and related regulatory information on an ongoing to an as-needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management.
• Ensures the accuracy of broad reports, documents, tests, procedures and operational databases, and related details through audits, queries, and operational reviews; works with teams to resolve discrepancies.
• Assists with developing or participating in a regulatory or cross-functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management.
• Interprets and applies department policies and procedures and assists with applicable laws, rules, and regulations; receives guidance within these areas as needed.
• Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
• Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.

QUALIFICATIONS:

Education and Experience:

Bachelor's degree in chemistry, environmental sciences, operations, or a closely related field; AND at least five (5) years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience.

Required Knowledge and Skills

Required Knowledge:

• Very complex to specialized principles, practices, and techniques of product stewardship and/or regulatory affairs.
• Broad understanding of the administration and oversight of product stewardship and/or regulatory affairs programs, policies, and procedures.
• Very complex to specialized methods to resolve product stewardship and/or regulatory affairs problems, questions, and concerns.
• Broad understanding of applicable regulatory laws, codes, and regulations.
• Computer applications and systems related to the work.
• Principles and practices to serving as an effective project team member.
• Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
• Correct business English, including spelling, grammar, and punctuation.

Required Skills:

• Performing very complex to specialized professional-level regulatory duties in a variety of assigned areas.
• Overseeing and administering broad and various regulatory functions.
• Training others in policies and procedures related to the work.
• Serving as a team member and the development and management of projects.
• Operating in both a team and individual contributor environment.
• Interpreting, applying, and explaining applicable laws, codes, and regulations.
• Preparing very complex to specialized functionals reports, correspondence, and other written materials.
• Using initiative and independent judgment within established department guidelines.
• Using tact, discretion and prudence in working with those contacted in the course of the work.
• Performing effective oral presentations to large and small groups across functional peers and the department.
• Contributing effectively to the accomplishment of team or work unit goals, objectives, and activities.
• Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.

Responsibilities of this position may include direct and/or indirect physical or logical access to information, systems, technologies subjected to the regulations/compliance with U.S. Export Control Laws.

U.S. Export Control laws and U.S. Government Department of Defense contracts and sub-contracts impose certain restrictions on companies and their ability to share export-controlled and other technology and services with certain "non-U.S. persons" (persons who are not U.S. citizens or nationals, lawful permanent residents of the U.S., refugees, "Temporary Residents" (granted Amnesty or Special Agricultural Worker provisions), or persons granted asylum (but excluding persons in nonimmigrant status such as H-1B, L-1, F-1, etc.) or non-U.S. citizens