QA Document Control Specialist

Position: QA Document Control Specialist 1
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Position Title:

Document Control Specialist 1

Generic Position Code/

Title:

SCI
25/Quality Coordinator Business Stream:

Pharmaceutical and Beauty and Personal Care

Location:

Torrance, CA USALine Manager:

Quality Assurance Director Direct Reports:

N/AFLSA Status:

Non-Exempt Primary Objective:

The Document Control Specialist 1 will be responsible for administering routine QA activities directly related to data entry, issuing, editing, filing, and archiving of quality systems data and documentation.

Position Duties and Scope:
** The*
* ** Document Control Specialist 1*
* ** has the following duties:
*** Maintain and administer controlled document system, including standard operating procedures, test methods, forms, and supporting documents.
* Assist in editing of controlled documents, including design of forms.
* Issue controlled copies of Forms to individual departments and administer tracking system for satellite document sets.
* Maintain document revision activity and files of completed DCR’S (document change record), and other quality system documentation, as applicable.
* Generate, issue, and archive laboratory notebooks.
* Proactively manage the document lifecycle process.
* Maintain archives of completed laboratory notebooks, validation projects, and master documents.
* Administer the collaboration with external archival storage facilities, as necessary.
* This includes verification of items for archival, scheduling of archive pick-up and retrievals, and confirmation of destruction activities in compliance with retention policy.
* Maintain training record files for employees, as necessary.
* Act as Document Control Administrator for Electronic Quality Management System.
* Train employees on document control processes to ensure ongoing compliance.
* Support Human Resources with New Hire documentation.
* Creates set-up of new employees and termed employee de-activation of in the Electronic Quality Management System.
* Meeting agenda preparation and minute recording, as necessary.
* Retrieve documentation for client and external audits.
* Maintain the documents needed for the Audit Ready box.
* Support supply ordering for the QA department.
* Maintain an understanding of and ensures compliance to Quality System including the manual, system procedures (cGMPs and cGDPs) and procedures as applicable to ISO 9001and ISO 17025
* Maintain a clean and organized workspace.
* Exercise Laboratory safety practices.
* Other duties as required.

Position Requirements /Essential Criteria:
* Minimum:
Associate’s degree or equivalent.
* Preferred:
Bachelor’s degree in a related field such as:
* Business Administration
* Quality Assurance / Quality Management
* Life Sciences or similar
* 2–4 years of experience in document control, records management, or quality systems (e.g., in manufacturing, pharma, biotech, or engineering environments).
* Experience with Quality Management Systems (QMS) or Electronic Document Management Systems (EDMS) (e.g., Master Control, CPro, Track Wise, eQMS).
* Familiarity with ISO 9001, ISO 17025, cGMP, or FDA 21 CFR Part 11 requirements, depending on industry.

Core Competencies:

* Proficient in:
* Microsoft Office (Word, Excel, PowerPoint, Outlook, Adobe Acrobat.)
* Electronic document control systems (EDMS/eQMS)
* Document lifecycle management (creation, revision, approval, archival)
* Understanding of:
* Change control and document numbering systems
* Version control and document traceability
* Controlled copy issuance and retrieval processes
* Proficient verbal and written communication skills.
* Excellent organizational skills and attention to detail.
* Remains flexible, professional, and patient when dealing with changing priorities and assignments.
* Comprehension and awareness of the importance of achieving regulatory compliance.
* ** Key

Competencies:

*** Knowledge of
** document workflows
** and
** approval processes
*** Ability to
** audit documentation
** for accuracy and compliance
* Competence in
** training or supporting users
** in document…