PLS GMP Data Reviewer (Pharma)

Location: Oakdale, Minnesota, United States; full-time onsite. Schedule: Monday through Friday, 8:00 a.m. to 5:00 p.m.

Salary: $55,000–$65,000 per year.

Company

Pace Life Sciences provides contract CMC development, clinical trial material manufacturing, regulatory compliance, consulting, facility support, and GMP analytical testing services for pharmaceutical, biopharmaceutical, and gene therapy clients.

What you will do

• Review, write, update, complete, and process GMP quality forms, manufacturing batch records, technical records, laboratory data, SOPs, quality exceptions, logbooks, tracking systems, and LIMS reports.
• Analyze quality operations, results, and feedback to identify trends, draw conclusions, and present recommendations to management.
• Audit tests, equipment, procedures, databases, and reports; investigate discrepancies and coordinate their resolution with relevant teams.
• Provide quality policy guidance and counsel to staff, management, and functional leaders.
• Support quality and cross-functional projects, including objectives, budgets, timelines, materials, and personnel requirements.
• Interpret applicable quality policies, laws, codes, and regulations and contribute to team effectiveness.

Requirements

• Bachelor’s degree in chemistry, operations, or a closely related field, plus 2–4 years of quality experience; an equivalent combination of education, training, and experience may be considered.
• Knowledge of quality principles, quality program administration, quality problem resolution, and applicable laws, codes, and regulations.
• Understanding of testing tools, laboratory equipment, calibration, and related computer applications and systems.
• Ability to prepare complex reports and written materials, deliver presentations, train others, and work independently or as part of a project team.
• Correct business English, including spelling, grammar, and punctuation.
• Ability to work onsite in a laboratory and office environment in Oakdale, Minnesota, Monday through Friday.

Culture & Benefits

• Work in laboratory and office settings supporting quality, safety, and pharmaceutical science.
• Exposure to chemicals, fumes, gases, odors, and other laboratory conditions.
• Medical, dental, vision, life, disability, HSA, FSA, wellness, and voluntary benefits.
• 401(k) retirement plan with immediate vesting in the employer match.
• Paid holidays, sick leave, vacation days, parental leave, tuition reimbursement, and an Employee Assistance Program.
• Optional legal coverage and identity theft protection.