PLS Technical Writer

Pace Analytical Services•Oakdale, MN

8d•Onsite

About The Position

Pace Life Sciences is hiring a full-time, onsite Technical Writer in Oakdale, Minnesota. The role authors, coordinates, and maintains Quality Management System (QMS) documentation and quality records in support of compliant GMP operations in a regulated contract testing laboratory. The Technical Writer partners with Operations, Laboratory, Quality Assurance, Program Management, and subject matter experts to create and manage controlled documentation, including investigations, deviations, OOS/OOT events, CAPAs, change controls, and SOPs. Documentation must be scientifically sound, inspection-ready, and compliant with cGMP regulations, data integrity requirements, and internal quality standards. Pace Life Sciences provides contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to pharmaceutical, biopharmaceutical, and gene therapy industries. This position supports timely resolution of quality events, audit readiness, and continuous improvement initiatives. The schedule is Monday through Friday, 8:00 AM to 5:00 PM. Compensation is $55,000–$65,000 per year, 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 Life Sciences, Quality Assurance, Technical Communication, or a related scientific discipline.
Three 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.
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 written procedures and technical documentation.
Knowledge of 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 attention to detail, accuracy, completeness, and consistency when organizing documentation and 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 communication and collaboration skills for working with cross-functional stakeholders to gather information and resolve documentation-related issues.
Ability to use Microsoft Office applications and electronic document management systems to prepare, maintain, and manage controlled documentation.
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.

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 in the electronic quality management system (eQMS).
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.
Contribute suggestions and participate as an active member of a work team to improve departmental service and efficiency.
Promote Pace’s mission through courteous, cooperative interactions with customers and staff and by supporting a harmonious, effective workplace.

Benefits

Medical insurance
Dental insurance
Vision insurance
401(k) retirement savings plan with employer match that is 100% vested immediately
Life insurance
Disability benefits
Voluntary benefits
Paid holidays
Paid sick days
Paid vacation days
Health Savings Account (HSA)
Wellness program
Flexible spending accounts
Tuition reimbursement
Employee Assistance Program
Parental leave
Optional legal coverage
Identity theft coverage