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, CTM manufacturing, regulatory compliance, consulting, facility support, GMP analytical testing, and manufacturing services for pharmaceutical, biopharmaceutical, and gene therapy programs.

What you will do

• Review, write, update, complete, and process GMP quality records, batch records, technical records, SOPs, quality exceptions, logbooks, databases, and LIMS data.
• Analyze quality operations, laboratory results, feedback, and records to identify trends, draw conclusions, and recommend improvements.
• Audit tests, equipment, procedures, databases, and reports to verify accuracy and resolve discrepancies with cross-functional teams.
• Provide quality guidance and interpretation of policies, procedures, laws, codes, and regulations to staff, management, and functional leaders.
• Support quality and cross-functional projects, including timelines, budgets, resources, implementation, and management presentations.
• Research and resolve customer, management, and employee questions while contributing to team objectives and training others on applicable procedures.

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 programs, applicable laws and regulations, testing equipment, calibration, and related computer systems.
• Experience performing professional-level quality duties, administering quality functions, preparing reports, and applying independent judgment.
• Ability to interpret and explain regulations, conduct audits and reviews, deliver presentations, train others, and work independently and collaboratively.
• Ability to work onsite in Oakdale, Minnesota, Monday through Friday, 8:00 a.m. to 5:00 p.m.
• Correct business English, including spelling, grammar, and punctuation, is required.

Culture & Benefits

• Work in a laboratory and office environment supporting pharmaceutical, biopharmaceutical, and gene therapy programs.
• Exposure to chemicals, fumes, gases, noxious odors, and other laboratory-related conditions.
• Full-time benefits include medical, dental, vision, life and disability coverage, a 401(k) plan, HSA, flexible spending accounts, and paid holiday, sick, and vacation time.
• Additional benefits include wellness programs, tuition reimbursement, an Employee Assistance Program, parental leave, optional legal coverage, and identity theft protection.
• Physical requirements include extended sitting, use of laboratory and office equipment, and occasional lifting of up to 20 pounds.