PLS GMP Data Reviewer (Pharma)

Pace® Analytical Services•Oakdale, MN

5d•$55,000 - $65,000•Onsite

About The Position

Pace Life Sciences is hiring a full-time, onsite GMP Data Reviewer in Oakdale, Minnesota. The role oversees, reviews, writes, updates, completes, and processes quality forms, documents, databases, and related information, including manufacturing batch records, technical records, laboratory and quality-control data, standard operating procedures, quality exceptions, logbooks, tracking systems, and LIMS data and reports. Records may be electronic or paper, including laboratory notebooks. The reviewer provides analysis, interpretation, and guidance on quality policies, programs, and practices; helps resolve management and employee questions; analyzes quality operations and results to identify trends and present recommendations; and verifies the accuracy of tests, equipment, procedures, databases, and reports through audits and operational reviews. The role also contributes to quality and cross-functional projects, applies department policies and applicable regulations, and supports effective service and teamwork. The position requires a bachelor's degree in chemistry, operations, or a closely related field and two to four years of quality experience, including experience with complex programs or operations, or an equivalent combination of education, training, and experience. Work is performed in a laboratory and office setting and involves exposure to chemicals, fumes, gases, noxious odors, and related laboratory conditions. The regular schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m.

Requirements

Bachelor's degree in chemistry, operations, or a closely related field, and two to four years of quality experience, including complex programs or operations; or an equivalent combination of education, training, and experience.
Knowledge of quality principles, practices, techniques, program administration, policies, and procedures.
Knowledge of methods for resolving quality problems and of applicable quality laws, codes, and regulations.
Understanding of testing tools, equipment, and calibration.
Familiarity with computer applications and systems related to the work.
Ability to perform professional quality duties, oversee quality functions, and train others in related policies and procedures.
Ability to contribute to project development and management and work both as a team member and an individual contributor.
Ability to interpret, apply, and explain applicable laws, codes, and regulations.
Ability to prepare reports, correspondence, and other written materials and deliver oral presentations to small and large groups.
Ability to use initiative and independent judgment within established guidelines and exercise tact and discretion.
Effective communication and relationship-building skills and ability to contribute to team goals.
Mobility to work in a laboratory and office, use standard office and laboratory equipment, and sit for extended periods.
Ability to occasionally exert up to 20 pounds of force and frequently exert up to 10 pounds of force to lift, carry, push, pull, or move objects.
Vision to read printed materials and computer screens, and hearing and speech to communicate in person or by telephone.

Responsibilities

Oversee, review, write, update, complete, and process quality forms, documents, databases, and related materials, including batch records, technical records, laboratory and quality-control data, SOPs, quality exceptions, logbooks, tracking systems, and LIMS data and reports.
Provide analysis, interpretation, and counsel to staff, management, and functional leaders on quality policies, programs, and practices.
Research and help resolve management and employee questions and requirements; assist with customer feedback and coordinate resources and responses.
Analyze quality operations, results, feedback, and other information to identify trends, interpret findings, and present results and recommendations to management.
Verify the accuracy of tests, equipment, actions, procedures, operational databases, and reports through audits, queries, and operational reviews, and work with teams to resolve discrepancies.
Assist with developing or participating in quality and cross-functional projects, including objectives, budgets, timelines, materials, and personnel requirements.
Interpret and apply department policies and procedures and assist with applicable laws, rules, and regulations.
Contribute suggestions and participate in work teams to support department effectiveness and customer service.
Promote a courteous, cooperative, and harmonious workplace when interacting with customers and staff.