PLS Document Control Specialist

Shift: Monday through Friday, 8:00 AM - 5:00 PM 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 an onsite, full-time, PLS Document Control Specialist position located in Oakdale, MN, Monday - Friday, from 8:00 a.m. - 5:00 p.m. Compensation: $40,000 - $45,000 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.

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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.

Quality Assurance Specialist I Pace ® Analytical Life Sciences (PLS) is an industry leading contract lab supplying analytical chemistry and microbiology services to the Medical Device, Pharmaceutical, and Life Sciences industry. Since our formation in 2006 we have grown at a rate of over 10% per year and established ourselves as one of the top ten contract laboratories within the United States providing cGMP services to a wide range of clients worldwide.

We attribute our rapid growth to our solid quality system combined with an exceptional culture of client service. SUMMARY Responsible for performing Quality Assurance document and record management activities in a cGMP contract laboratory testing setting.

Performs tasks in MasterControl eDMS for internal documents, external documents and quality exceptions. Scans and files technical and quality records.

Retrieves filed records as requested and maintains established filing system. Assigns document and exception numbers, and enters associated metadata, in LIMS.

Coordinates migration of documents from acquisition facilities into the PLS systems. Provides general support to Quality Assurance groups as needed.

ESSENTIAL FUNCTIONS Candidate(s) may be expected to perform job-related duties other than those listed below. Performs quality assurance, document and record management tasks with strong attention to detail Maintains the QA exception (investigation, deviation, out of tolerance, etc.) report database, including assigning tracking numbers, entering all relevant data and closing exceptions Participates in the off-site document/record archival and retrieval process Provides support to remote QA Data Review group as needed Migrates documents from acquisition facilities to the PLS systems Provides support to Quality Assurance groups as needed and as assigned Promotes and supports the overall mission of Pace® Analytical 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 and desired.

Education and Experience Bachelor's degree (BA/BS) in chemistry or other Life Science discipline; OR an equivalent combination of education, training, and experience. REQUIRED/DESIRABLE KNOWLEDGE AND SKILLS Required Knowledge/Skills Proficiency with English (verbal and written) Proficiency in Microsoft Word Excellent organizational and time management skills Strong attention to detail and accuracy Flexibility to handle multiple tasks concurrently and in a timely fashion Good interpersonal skills and ability to work both independently and in a team environment Ability to communicate effectively with both internal and external customers Adaptability to manage changing task assignments and priorities Desirable Knowledge/Skills Document and exception authoring Adobe Acrobat Administration of MasterControl eDMS or other electronic document management system Familiarity with LIMS or other similar database Knowledge and/or familiarity with FDA GMP or other regulated industry Knowledge of Good Documentation Practices 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 chemicals, fumes, gasses, noxious odors and related items in a lab setting.

May be required to wear personal protective equipment (PPE). OFCCP Statement - Pace Analytical