GMP Data Reviewer (Pharma)

About the role

This is a full-time, onsite, GMP Data Reviewer position located in Oakdale, MN, Monday through Friday, 8:30 a.m. - 5:00 p.m.

Responsibilities

• Overseeing, reviewing, writing, updating, completing, and processing quality forms, documents, databases, and related materials and information.
• Provides intermediate to complex analysis, interpretation and counsel to staff, management, and functional leaders regarding quality policies, programs, and practices.
• Provides various 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 intermediate to complex operations, results, feedback, and related quality information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management.
• Ensures the accuracy of various tests, equipment, actions, procedures and operational databases, reports, and related details through audits, queries, and operational reviews; works with teams to resolve discrepancies.
• Affords assistance in developing or participating in quality 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.
• 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

• Bachelor's degree in chemistry, operations, or a closely related field; AND two to four (2-4) years of quality experience, including experience with complex programs or operations; OR an equivalent combination of education, training, and experience.
• Required Knowledge: Intermediate to complex principles, practices, and techniques of quality. Various understanding of the administration and oversight of quality programs, policies, and procedures. Intermediate to complex methods to resolve quality problems, questions, and concerns. Various understanding of applicable quality laws, codes, and regulations. Understanding of various testing tools, equipment, and calibration.
• Required Skills: Performing intermediate to complex professional-level quality duties in a variety of assigned areas. Overseeing and administering comprehensive and varied quality 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 a both a team and individual contributor environment. Interpreting, applying, and explaining applicable laws, codes, and regulations. Preparing intermediate to complex 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.