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.