QA Document Control Specialist 1

ALS • Torrance, CA

67d

About The Position

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. This position involves maintaining and administering the controlled document system, assisting in editing controlled documents, issuing controlled copies of forms, maintaining document revision activity, generating and archiving laboratory notebooks, and managing the document lifecycle process. The role also includes maintaining training records, supporting Human Resources with new hire documentation, preparing meeting agendas, retrieving documentation for audits, and ensuring compliance with quality systems and safety practices.

Requirements

• 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.

Nice To Haves

• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook, Adobe Acrobat).
• Proficient in electronic document control systems (EDMS/eQMS).
• Understanding of change control and document numbering systems.
• Proficient verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Knowledge of document workflows and approval processes.
• Ability to audit documentation for accuracy and compliance.
• Competence in training or supporting users in document control processes.

Responsibilities

• 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.
• 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.
• Create set-up of new employees and termed employee de-activation in the Electronic Quality Management System.
• Prepare meeting agendas and record minutes 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 ensure compliance to Quality System including the manual, system procedures (cGMPs and cGDPs) and procedures as applicable to ISO 9001 and ISO 17025.
• Maintain a clean and organized workspace.
• Exercise Laboratory safety practices.
• Other duties as required.

Benefits

• Safe working environment.
• Opportunities for professional development.
• Support for a diverse career path.
• Commitment to employee well-being.

What This Job Offers

• Job Type: Full-time
• Industry: Professional, Scientific, and Technical Services
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees