PLS Technical Writer

## PLS Technical Writer Apply:
On-site:
Oakdale, MN:
Full time:
Posted Today:
JR263136

Shift: Monday - Friday, 8:00 AM - 5:00 PMAre 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:** $55,000-$65,000 Annually
* 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…