PLS Technical Writer

Shift:

Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.

This is a full-time, onsite, Technical Writer position located in Oakdale, MN, Monday through Friday, 8:00 AM to 5:00 PM.

Compensation: $70,000-$95,000 per year

The salary for this position reflects a variety of factors. 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.

Make an Impact. Build a Career.

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.

SUMMARY:

Responsible for authoring, coordinating, and maintaining Quality Management System (QMS) documentation and quality records in support of compliant GMP operations within a regulated contract testing laboratory environment. Partners closely with Operations, Laboratory, Quality Assurance, Program Management, and subject matter experts to develop, revise, and manage controlled documentation, including investigations, deviations, out-of-specification (OOS) and out-of-trend (OOT) events, corrective and preventive actions (CAPAs), change controls, and standard operating procedures (SOPs). Ensures documentation is scientifically sound, inspection-ready, and compliant with cGMP regulations, data integrity requirements, and internal quality standards while supporting timely resolution of quality events, audit readiness, and continuous improvement initiatives.

ESSENTIAL FUNCTIONS:

This class specification lists the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform job-related duties other than those contained in this document and may be required to have specific job-related knowledge and skills.

• Authors, revises, and maintains controlled GMP documentation, including SOPs, work instructions, forms, protocols, training materials, and quality records.

• Drafts, edits, and coordinates investigation reports, deviations, CAPAs, change controls, complaints, and OOS/OOT documentation.

• Translates complex laboratory, operational, and quality data into clear, concise, accurate, and scientifically sound technical documentation.

• Ensures documentation complies with FDA cGMP regulations, data integrity requirements, ICH guidance, internal quality standards, and document control procedures.

• Leads or supports root cause analyses, CAPA development, and change control documentation activities.

• Partners with cross-functional teams, including Operations, Laboratory, Quality Assurance, and scientific personnel, to gather information and resolve documentation-related issues.

• Manages document review, approval, implementation, version control, periodic review, and archival activities within the electronic quality management system (eQMS).

• Reviews technical content for accuracy, completeness, consistency, compliance, and inspection readiness while maintaining high documentation standards.

• Supports internal, client, and regulatory audit readiness activities, including response preparation, documentation corrections, and continuous improvement initiatives.

• Monitors and reports quality metrics and trends related to investigations, deviations, CAPAs, and change controls to support management review and process improvement.

• Contributes 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.
• Promotes and supports the overall mission of Pace® by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and Experience:

Bachelor’s degree in a Life Sciences field, Quality Assurance, Technical Communication, or a related scientific discipline; AND three (3) or more years of experience in a pharmaceutical, medical device, cGMP, or other regulated environment. Familiarity with cGMP requirements, Good Documentation Practices (GDP) principles, and FDA regulatory expectations is required.

Required Knowledge and Skills

Required Knowledg e:

• GMP documentation standards, cGMP requirements, GDP principles, FDA regulatory expectations, and ICH guidance.

• Data integrity principles and internal quality standards applicable to controlled documentation and quality records.

• QMS documentation, including investigations, deviations, OOS/OOT events, CAPAs, change controls, complaints, and SOPs.

• Document control procedures, including review, approval, implementation, version control, periodic review, and archival.

• Root cause analysis tools and their application to investigations and corrective and preventive actions.

• Laboratory and operational processes as they relate to compliant written procedures and technical documentation.

• Microsoft Office applications, electronic document management systems, and electronic quality management systems.

• Correct business English, including spelling, grammar, and punctuation.

Required Skills:

• Authoring, editing, and formatting clear, concise, accurate, and scientifically sound technical documentation.

• Managing multiple document workflows and timelines simultaneously in a fast-paced contract testing environment.

• Organizing documentation and reviewing technical content with strong attention to detail, accuracy, completeness, and consistency.

• Applying root cause analysis tools to investigations and supporting CAPA development.

• Interpreting laboratory and operational processes and translating them into compliant written procedures.

• Communicating and collaborating effectively with cross-functional stakeholders to gather information and resolve documentation-related issues.

• Using Microsoft Office applications and electronic document management systems to prepare, maintain, and manage controlled documentation.

• Interpreting complex laboratory, operational, and quality data and conveying technical information clearly in writing.

• 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 herein 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; and 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.

Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.

Benefits

When you join Pace®, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 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, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.

Equal Opportunity Employer

Pace® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.