PLS GMP Data Reviewer (Pharma)

Pace Analytical Services • Oakdale, MN

3d • Onsite

About The Position

Pace Life Sciences is hiring a full-time, onsite GMP Data Reviewer in Oakdale, Minnesota. The position reviews, prepares, 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; researches and helps resolve questions and requirements; and analyzes operational results and quality information to identify trends and present findings and recommendations to management. The role also audits and reviews tests, equipment, actions, procedures, databases, and reports for accuracy, works with teams to resolve discrepancies, and assists with quality and cross-functional projects. The role applies department policies and procedures and relevant laws and regulations, contributes to team effectiveness, and supports a courteous and cooperative workplace.

Work takes place in a laboratory and office setting and may involve exposure to chemicals, fumes, gases, noxious odors, and related items. The schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m. Compensation is $55,000–$65,000 per year, with the final offer influenced by factors such as location, experience, education, skills, internal equity, market conditions, budget, and organizational guidelines.

Requirements

• Bachelor's degree in chemistry, operations, or a closely related field, and 2–4 years of quality experience, including experience with complex programs or operations; or an equivalent combination of education, training, and experience.
• Knowledge of quality principles, practices, and techniques; quality program administration and oversight; methods for resolving quality problems; and applicable quality laws, codes, and regulations.
• Understanding of testing tools, equipment, and calibration, as well as computer applications and systems related to the work.
• Knowledge of project-team practices and methods of communicating with staff, coworkers, and customers to support safe and effective operations.
• Correct business English, including spelling, grammar, and punctuation.
• Ability to perform professional quality duties, oversee varied quality functions, train others, contribute to project development and management, and work as both a team member and individual contributor.
• Ability to interpret, apply, and explain applicable laws, codes, and regulations; prepare reports and written materials; and use initiative and independent judgment within department guidelines.
• Ability to communicate effectively, including presentations to groups, exercise tact and discretion, contribute to team goals, and maintain effective working relationships.
• Ability to meet the role's physical demands, including working in a laboratory and office, using standard office and lab equipment, sitting for extended periods, and occasionally exerting up to 20 pounds of force and frequently up to 10 pounds of force.

Responsibilities

• Oversee, review, write, update, complete, and process quality forms, documents, databases, and related information, 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 guidance to staff, management, and functional leaders regarding quality policies, programs, and practices.
• Research and help resolve management and employee questions and requirements; assist with receiving customer feedback and coordinating resources and responses.
• Analyze operations, results, feedback, and quality information to identify trends, draw conclusions, interpret findings, and present results, proposals, and recommendations to management.
• Verify the accuracy of tests, equipment, actions, procedures, databases, reports, and related details through audits, queries, and operational reviews; work with teams to resolve discrepancies.
• Assist with or participate in quality and cross-functional project or program objectives, including planning budgets, timelines, materials, personnel, and other requirements; present information to management.
• Interpret and apply department policies and procedures and assist with applicable laws, rules, and regulations.
• Contribute to department effectiveness by offering suggestions and directing or participating as an active work-team member.
• Promote the company's mission and a harmonious workplace through courteous, cooperative interactions with customers and staff.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement savings plan with employer match that is 100% vested immediately
• Life insurance
• Disability benefits
• Voluntary benefits
• Paid holidays, sick days, and vacation days
• Health savings account (HSA)
• Wellness program
• Flexible spending accounts
• Tuition reimbursement
• Employee Assistance Program
• Parental leave
• Optional legal coverage
• Identity theft coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level