Rate of pay is *** KEY RESPONSIBILITIES
A. 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.
B. 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.
C. 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.
Rate of pay is *** KEY RESPONSIBILITIES
A. 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.
B. 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.
C. 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.
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