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PLS QA Document Control Specialist

Pace Analytical Services

  • Oakdale, Minnesota
  • 4 days ago

    Highlights

    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.

    Numbers & Facts

    LocationOakdale, Minnesota
    IndustryOther/Not Classified
    Company Size2,500 to 4,999 employees
    Year Founded1978
    Websitehttps://www.pacelabs.com/

    Description

    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: $21.00 - $24.00 per hour

    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 performing and managing QA administrative and document control tasks while following current Good Manufacturing Practice (cGMP), under the supervision of experienced Quality Professionals. 

    ESSENTIAL FUNCTIONS
    This job description lists the major duties and requirements of the position and is not all-inclusive. Applicable essential functions may vary by site.  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. 

    • Performs quality assurance and record management tasks with strong attention to detail 

    • Provides excellent customer service and QA support to all internal and external PLS customers 

    • Maintains various filing systems, including labeling of folders, scanning/filing records, maintaining folder inventory and filing system 

    • Scans and files technical and quality records and maintains records in a readily retrievable state 

    • Prepares and coordinates records for off-site archival and retrieval 

    • Maintains the QA report databases by entering and updating all relevant data within the related system 

    • Prepares and assembles logbooks for data entry and assigns tracking numbers for notebooks 

    • Provides administrative support to remote and on-site QA team members 

    • Contributes to the efficiency and effectiveness of the department’s services to its customers by participating as an active member of a work team 

    • Promotes and supports the overall mission of Pace® 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.


    Education and Experience
    High School Diploma/GED; AND one year of administrative experience, specifically with administrative document control; OR an equivalent combination of education, training, and experience. 


    Required Knowledge and Skills

    Required Knowledge:

    • Excellent organizational and time management skills 

    • Strong attention to detail and accuracy 

    • Flexibility to handle multiple tasks concurrently and in a timely manner 

    • 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 

    Required Skills:
    Proficiency in Microsoft Word and Microsoft Excel.

    Desirable Knowledge and Skills:

    • Proficiency in Microsoft Office 365, including Outlook and Teams 

    • Proficiency with Adobe Acrobat 

    • Experience with electronic document management systems (e.g., MasterControl eDMS)  

    • Experience using laboratory information management system (LIMS) 

    • Experience working in an FDA regulated environment or familiarity with FDA cGMP regulations  


    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.

    Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.

    Benefits
    When you join Pace®, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.

    Equal Opportunity Employer

    Pace® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

    About Company

    Three divisions. Two countries. 1800 employees. Twenty-eight environmental labs. Two Life Sciences labs. Twenty-four service centers. Hundreds of certifications. 38 years of industry experience. Financial stability. Dynamic thought leadership and strategic management planning with one shared vision: work together to protect our environment and improve our health.

    Pace began on a much smaller scale in 1978, serving Minneapolis and the surrounding areas with founder and CEO Steve Vanderboom at the helm. A commitment to safety and high ethical standards, respect for both clients and employees, and a drive for excellence inspired us as we expanded - and these values are at the core of everything we do today. Still under Vanderboom's directorship, we are proud to be industry leaders, offering an unparalleled range of services delivered by the most experienced scientific professionals. No matter the scope of work or special requirements, we have the people, knowledge and technology to tackle them. Partnering with us, clients are guaranteed to experience the Pace Analytical difference.

    Pace Analytical Services, LLC. provides analytical services including environmental testing and sampling. Laboratories utilize EPA, ASTM Standard Methods, NIOSH and other accepted test procedures and methods in accordance with both federal and state regulations. Pace also provides specialty analytical support for air toxics, aquatic toxicity, bioassay, biota, dioxin/furans, low-level mercury, radiochemistry, vapor intrusion, environmental forensics, industrial hygiene, etc.

    Pace Analytical Life Sciences provides analytical testing services to the pharmaceutical/medical device industries. Services include chemical and microbiology, method development/validation, physical testing, raw material testing, stability testing and storage, and product release testing. Pace operates two FDA-registered, DEA-registered (Class I - V), cGMP-compliant facilities: one located in Oakdale, MN and the other located in San German, PR. The Oakdale, MN facility is ISO/IEC 17025:2005 accredited.

    Pace Analytical Lab Ops Division provides professional scientific staffing - to accommodate full outsourcing or augmentation of staff at a client's on-site location - to various industries as well as research and development organizations. The ISO 9001:2008 certified Lab Ops Division also provides instrumentation sales, repair and qualification services, product and materials testing support and regulatory compliance services.

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