PLS Technical Writer

Pace® Analytical Services•Oakdale, MN

9d•$55,000 - $65,000•Onsite

About The Position

Pace Life Sciences is hiring a full-time, onsite Technical Writer in Oakdale, Minnesota. The role supports compliant GMP operations in a regulated contract testing laboratory by authoring, coordinating, and maintaining Quality Management System (QMS) documentation and quality records. The Technical Writer works with Operations, Laboratory, Quality Assurance, Program Management, and subject matter experts to prepare and manage controlled documents and records, including investigations, deviations, OOS/OOT events, CAPAs, change controls, complaints, and SOPs. The position ensures documentation is scientifically sound, inspection-ready, and compliant with cGMP regulations, data integrity requirements, ICH guidance, and internal quality standards. It also supports timely resolution of quality events, audit readiness, and continuous improvement. The work takes place in a laboratory and office setting and includes interaction with chemicals, fumes, gases, noxious odors, and related items in the laboratory. The scheduled hours are Monday through Friday, 8:00 AM to 5:00 PM. Compensation is $55,000–$65,000 annually, with the final offer determined by factors including location, experience, education, skills, internal equity, market conditions, budget, and organizational guidelines.

Requirements

Bachelor's degree in a Life Sciences field, Quality Assurance, Technical Communication, or a related scientific discipline.
At least three 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.
Knowledge of GMP documentation standards, cGMP requirements, GDP principles, FDA regulatory expectations, and ICH guidance.
Knowledge of data integrity principles and internal quality standards for controlled documentation and quality records.
Knowledge of QMS documentation, including investigations, deviations, OOS/OOT events, CAPAs, change controls, complaints, and SOPs.
Knowledge of document control procedures, including review, approval, implementation, version control, periodic review, and archival.
Knowledge of root cause analysis tools and their application to investigations and corrective and preventive actions.
Knowledge of laboratory and operational processes as they relate to compliant procedures and technical documentation.
Proficiency with Microsoft Office applications, electronic document management systems, and electronic quality management systems.
Correct business English, including spelling, grammar, and punctuation.
Ability to author, edit, and format clear, concise, accurate, and scientifically sound technical documentation.
Ability to manage multiple document workflows and timelines simultaneously in a fast-paced contract testing environment.
Strong organization and attention to detail, accuracy, completeness, and consistency when reviewing technical content.
Ability to apply root cause analysis tools to investigations and support CAPA development.
Ability to interpret laboratory and operational processes and translate them into compliant written procedures.
Effective written and verbal communication and collaboration skills for working with cross-functional stakeholders.
Ability to interpret complex laboratory, operational, and quality data and convey technical information clearly in writing.
Ability to establish and maintain effective working relationships with a variety of individuals.
Mobility to work in a laboratory and office setting; ability to use standard office and laboratory equipment and sit for extended periods.
Ability to exert up to 20 pounds of force occasionally and/or up to 10 pounds 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 by telephone.

Responsibilities

Author, revise, and maintain controlled GMP documentation, including SOPs, work instructions, forms, protocols, training materials, and quality records.
Draft, edit, and coordinate investigation reports, deviations, CAPAs, change controls, complaints, and OOS/OOT documentation.
Translate complex laboratory, operational, and quality data into clear, concise, accurate, and scientifically sound technical documentation.
Ensure documentation complies with FDA cGMP regulations, data integrity requirements, ICH guidance, internal quality standards, and document control procedures.
Lead or support root cause analyses, CAPA development, and change control documentation activities.
Partner with Operations, Laboratory, Quality Assurance, scientific personnel, and other cross-functional teams to gather information and resolve documentation-related issues.
Manage document review, approval, implementation, version control, periodic review, and archival activities within the electronic quality management system.
Review technical content for accuracy, completeness, consistency, compliance, and inspection readiness.
Support internal, client, and regulatory audit readiness, including response preparation, documentation corrections, and continuous improvement initiatives.
Monitor and report quality metrics and trends related to investigations, deviations, CAPAs, and change controls to support management review and process improvement.
Suggest and participate in ways to improve the efficiency and effectiveness of departmental service, including active work-team participation.
Promote Pace's mission through courteous, cooperative interactions with customers and staff and by supporting a harmonious and effective workplace.

Benefits

Competitive salaries
Medical, dental, and vision benefits
401(k) retirement savings plan with immediate 100% vesting in the employer match
Life insurance
Disability benefits
Voluntary benefits
Paid holiday, sick, and vacation time
Health savings account (HSA)
Wellness program
Flexible spending accounts
Tuition reimbursement
Employee Assistance program
Parental leave
Optional legal coverage
Identity theft coverage