PLS QA Document Control Specialist
About this role
Shift:
Monday through 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 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.
Frequently Asked Questions
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