PLS GMP Data Reviewer (Pharma)

This is a full-time, onsite position located in Oakdale, MN.

Schedule

Monday through Friday, 8:00 AM - 5:00 PM

Pay

$55,000 - $65,000 per year. Compensation will be determined based on the candidate’s geographic location, relevant experience, education, skills, and alignment with internal equity. Market conditions, budgetary considerations, and organizational compensation guidelines may also influence the final offer.

About the role

Pace® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Operating across a network of CDMO sites, GMP analytical testing laboratories, and manufacturing support centers, we partner with clients to efficiently advance programs from early development through commercialization. Our experienced industry experts and continued investment in state-of-the-art facilities reflect our commitment to quality, speed, and reliability. United by a shared purpose, we bring meaningful value to patients, healthcare professionals, and health businesses worldwide by delivering services that support a safer, healthier future.

Responsibilities

• Oversee, review, write, update, complete, and process quality forms, documents, databases, and related materials and information, including but not limited to manufacturing batch records, technical records, pertinent laboratory or quality control data, standard operating procedures (SOPs), quality exceptions, logbooks, tracking systems, and LIMS data/reports. Data and records may be in electronic or paper form or laboratory notebooks.
• Provide intermediate to complex analysis, interpretation, and counsel to staff, management, and functional leaders regarding quality policies, programs, and practices; lead implementation and change.
• Provide research, feedback, and decisions to resolve management and employee questions and requirements; assist with receiving customer feedback and coordinating resources and responses as required.
• Analyze and review intermediate to complex operations, results, feedback, and related quality information to determine trends, draw conclusions, interpret findings, and present results, proposals, and recommendations to management.
• Ensure the accuracy of various tests, equipment, actions, procedures, and operational databases and reports through audits, queries, and operational reviews; work with teams to resolve discrepancies.
• Assist with developing or participating in quality or cross-functional project or program objectives, including proposed budgets, timelines, materials, personnel, and other project requirements; receive direction and present information to management.
• Interpret and apply department policies and procedures and assist with applicable laws, rules, and regulations; receive guidance within these areas as needed.
• Contribute to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
• Promote and support the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; act in a manner that promotes a harmonious and effective workplace environment.

Requirements

• 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.
• Intermediate to complex knowledge of principles, practices, and techniques of quality.
• Understanding of the administration and oversight of quality programs, policies, and procedures.
• Intermediate to complex methods to resolve quality problems, questions, and concerns.
• Understanding of applicable quality laws, codes, and regulations.
• Understanding of various testing tools, equipment, and calibration.
• Proficiency with computer applications and systems related to the work.
• Knowledge of principles and practices to serve as an effective project team member.
• Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
• Correct business English, including spelling, grammar, and punctuation.

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 contributing to the development and management of projects.
• Operating in both a team and individual contributor environment.
• Interpreting, applying, and explaining applicable laws, codes, and regulations.
• Preparing intermediate to complex functional 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.
• Contributing effectively to the accomplishment of team or work unit goals, objectives, and activities.
• Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.

Physical/Mental Requirements

The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Mobility to work in a lab and office setting, use standard office and lab equipment, and stamina to sit for extended periods of time.
• Exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull, or move objects.
• Vision to read printed materials and computer screens.
• Hearing and speech to communicate in person or over the telephone.

Working Environment

Work is performed in a lab and office setting. Work is subject to chemicals, fumes, gases, noxious odors, and related items in a lab setting.

Benefits

Full-time roles are eligible for our comprehensive benefits program which includes:

• Competitive salaries
• Medical, dental, and vision coverage
• 401K retirement savings plan (100% vested immediately in the employer match)
• Life, disability, and voluntary benefits
• Paid time off for holiday, sick, and vacation days
• HSA and wellness program
• Flexible spending accounts
• Tuition reimbursement
• Employee Assistance program
• Parental leave
• Optional legal coverage and ID theft protection