QA Document Control Specialist 1

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At ALS, we encourage you to dream big. When you join us, youll be part of a global team harnessing the power of scientific testing and data-driven insights to build a healthier future.

Position

Title : Document Control Specialist 1

Generic Position Code / Title : SCI25 / Quality Coordinator

Business Stream : Pharmaceutical and Beauty and Personal Care

Location : Torrance, CA USA

Line Manager : Quality Assurance Director

Direct Reports : N / A

FLSA 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

• 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 DCRs (document change records), 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 collaboration with external archival storage facilities, as necessary.
• Verify items for archival, schedule archive pick-up and retrievals, and confirm 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.
• Create setup of new employees and deactivate terminated employees 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 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 and exercise Laboratory safety practices.
• Other duties as required.

Qualifications

Essential Criteria :

Core Competencies :

Occupational Health & Safety Responsibilities

Quality Responsibilities

Other Requirements

Note : This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Equal Opportunity Statement

ALS is an equal opportunity employer and is committed to fostering an inclusive work environment. Qualified candidates will be considered without regard to race, color, religion, national origin, military or veteran status, gender, age, disabilities, sexual orientation, gender identity, pregnancy and pregnancy-related conditions, genetic information and any other characteristics protected by law.

We invite resumes from all interested parties and provide accommodations on request for candidates taking part in the selection process.

How To Apply

Please apply online and provide a cover letter and CV that demonstrate your motivation and ability to meet the requirements of this role.

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