PLS Document Control Specialist

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 Master Control 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

• 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

• Document and exception authoring
• Adobe Acrobat
• Administration of Master Control 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…