QA Document Control Specialist 1

At ALS, we encourage you to dream big.

When you join us, you'll 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 :

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 :

Core Competencies :

Occupational Health & Safety Responsibilities :

Quality Responsibilities :

Safe

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.

Working at ALS

The ALS team is a diverse and dedicated community united by our passion to make a difference in the world.

Our values are important to us, and shape how we work, how we treat each other and how we recognise excellence.

At ALS, you'll be supported to develop new skills and reach your full potential. We invest in our people with programs and opportunities that help you build a diverse career with us.

We want everyone to have a safe, flexible and rewarding career that makes a positive impact on our people, the planet and our communities.

Everyone Matters

ALS is proud to be an equal opportunity employer and is committed to fostering an inclusive work environment where the strengths and perspectives of each employee are both recognised and valued.

Qualified candidates will be considered without regard to race, colour, 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 the law. We invite resumes from all interested parties, including women, members of minority groups, and persons living with disabilities.

ALS also welcomes applications from people with all levels of ability. Accommodation is available on request for candidates taking part in all aspects of the selection process.

Eligibility

To be eligible to work at ALS you must be a Citizen or Permanent Resident of the country you are applying for, or either hold or be able to obtain, a valid working visa.

How to apply

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