Quality Systems Document management

Job Details:

Role: Coord 1, Quality Document Sys Mgmt

Location : Branchburg, NJ

Duration: 02 months

Payrate: $32-35/hr. on W2.

Description:

Records Management & Document Control

– Perform QA review for GMP documentation. Verifies ALCOA requirements are met and test results against specifications.

– Issue controlled forms on a daily basis in accordance with document control procedures.

– Check out project folders for disposition review; maintain a controlled check-out log with dates, reviewer names, and return status.

– Check in project folders following disposition; update the controlled check-in log and verify folder completeness prior to filing.

– Check in and check out in-process folders on a daily basis; maintain an accurate and up-to-date tracking log for all active in-process records.

– Coordinate offsite archival activities for paper records (PV books, logbooks, notebooks) as applicable:

◦ Schedule pickups and drop-offs with designated archival vendor (TBD).

◦ Maintain a log of records sent offsite and facilitate retrieval of archived records upon request.

– Perform daily scanning of quality documents and upload to designated electronic drives or document management locations in a timely manner.

– Process Electronic Change Record Orders (ECROs) in accordance with site procedures.

Audit & Meeting Support

– Schedule internal and client audits, facility meetings, client meetings, and site visits as requested.

– Prepare the audit room the day prior to each audit:

◦ Print and place agenda, attendance sheet, and lunch list on the conference table.

◦ Set out water bottles, lab coats, safety glasses, branded pens and notebooks, monitor, hotspot, keyboard, and mouse.

◦ Fill the coffee machine with water and perform a general readiness walkthrough to ensure all materials are in place.

– Provide audit runner and/or back-room support during audits as applicable (e.g., document retrieval, logistical coordination, escorting visitors).

– Coordinate and place catering/lunch orders for audits and meetings as required.

Facilities & Site Services

– Process site-specific purchase orders and one-time purchase requests for Quality Department supplies in accordance with procurement procedures.

– Manage lab coat inventory rotation: arrange delivery to and pickup from dry cleaning services on an established frequency; maintain a tracking log.

QUALIFICATIONS

Education

– Associate's degree or higher in Business Administration, Life Sciences, Healthcare Administration, or a related field preferred.

– High school diploma or GED required; relevant experience may be considered in lieu of degree.

Experience

– 1–5 years of administrative experience in a regulated industry environment (pharmaceutical, medical device, clinical laboratory, or combination product preferred).

– Familiarity with GMP, GLP, or ISO 13485 documentation practices is an asset.

– Prior experience with document management systems or electronic quality management systems (eQMS) is a plus.

Skills & Competencies

– Strong organizational skills with demonstrated ability to manage multiple concurrent tasks and priorities with accuracy.

– High attention to detail and commitment to data integrity in all record-keeping activities.

– Proficiency in Microsoft Office Suite (Word, Excel, Outlook); comfort with electronic document management platforms.

– Effective written and verbal communication skills.

– Ability to work both independently and collaboratively within a Quality team environment.

– Discrete handling of confidential quality and client records.

– Professional demeanor and customer-service orientation when interfacing with internal stakeholders and external clients/auditors.

KM