PLS QA Document Control Specialist

This is an onsite, full-time position located in Oakdale, MN.

Schedule

• Monday through Friday, 8:00 AM - 5:00 PM

Pay

• $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.

About the role

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.

Responsible for the oversight and initiation of QA administrative and document control tasks while following current Good Manufacturing Practice (cGMP) under the supervision of more senior Quality Professionals.

Responsibilities

• Oversees quality assurance and record management tasks with strong attention to detail.
• Supervises the management of various order filing systems, including labeling of folders, scanning/filing records, maintaining folder inventory and filing system.
• Supports senior Quality Professionals in accessing technical and quality records and oversees that records are in a readily retrievable state.
• Oversees and manages off-site archival and retrieval as requested by senior Quality Professionals.
• Provides direct support managing the QA report databases and related systems.
• Oversees and directs logbook assembling and assignments.
• Coordinates administrative support to remote and on-site QA team members.
• Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
• 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.

Requirements

• Bachelor's degree in Life Sciences or a related field; AND three (3) years of administrative experience, specifically with management of administrative duties; OR an equivalent combination of education, training and experience.
• Ability to manage and direct requests from senior QA Professionals.
• Proficiency in Microsoft Word and Excel.
• 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.
• Proficiency with Adobe Acrobat.
• Management of electronic document management systems.
• Proficiency with LIMS or other similar databases.
• Direct conformity with FDA laws and regulations, cGMP practices, or other regulated industries.

Physical/Mental Requirements

• 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.
• 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 to chemicals, fumes, gasses, noxious odors and related items in a lab setting.

Benefits

• Competitive salaries
• Medical, dental, and vision coverage
• 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 and wellness program
• Flexible spending accounts
• Tuition reimbursement
• Employee Assistance program
• Parental leave
• Optional legal coverage and ID theft protection