ALS · 2 months ago
QA Document Control Specialist 1
ALS Group USA is a global team focused on scientific testing and data-driven insights to promote a healthier future. The Document Control Specialist 1 will oversee QA activities related to data management, document control, and compliance with quality systems. This role involves maintaining controlled documents, training employees on processes, and supporting audits.
Professional ServicesTest and Measurement
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
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
Qualification
Required
Minimum: Associate's degree or equivalent
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
Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook, Adobe Acrobat.)
Proficient in electronic document control systems (EDMS/eQMS)
Proficient in document lifecycle management (creation, revision, approval, archival)
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
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
Understanding of retention policies and records archiving
Follow all company operating procedures, standards, policies, and training to ensure the safe and efficient operation of the site
Play an active role in the ALS safety program by correcting or reporting unsafe acts and conditions that are observed during the day-to-day operations to create a zero-injury work environment
Participate in and support HSE initiatives, as required by ALS leadership
Understand and use HSE precautions (such as but not limited to fume hoods and PPE) while working with chemicals and samples of unknown hazards
Ensure the health and safety of staff, contractors, and/or visitors by providing appropriate leadership, due diligence, resources, training, and enforcement for all individuals onsite
Monitor and enforce the health, safety and environment policies, procedures and ensure compliance with the relevant regulations
Actively promote awareness of these policies, procedures, and regulations amongst company personnel
Actively support and participate in all OHS initiatives. Lead by example
Report all personal injuries and incidents and assist with investigations as per company policy
Ensure the company sites adhere to all environmental requirements as determined by government legislation, regulation, and company policy
Ensure business is conducted in accordance with Core Values: Safe, Resilient, Curious, Committed, Caring, Honest
Ensure Quality Systems are adhered to in performance, review, and reporting of laboratory duties and communicate all quality issues
Support Quality Department and Continuous Improvement Processes
Employees commit to improving the ALS experience through effective communication
Take appropriate steps to foreshadow potential risks and establish contingency plans
Ensure all statutory management and reporting requirements are met
Ensure compliance and continuous improvement of the Quality Management System
Working at a computer, up to eight (8) hours per day
Sitting and/or standing for extended periods of time, up to eight (8) hours per business day
Must be able to sit, stand, bend, push, pull, stoop and crouch up to 50% of the time while performing the duties of this position
Position may require the lifting of items up to 25 lb in weight
Preferred
Bachelor's degree in a related field such as: Business Administration, Quality Assurance / Quality Management, Life Sciences or similar
Company
ALS
ALS is an australia based testing services provider. It is a sub-organization of SerAmbiente.
Funding
Current Stage
Public CompanyTotal Funding
unknown1952-07-18IPO
Leadership Team
Recent News
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2025-11-11
2025-10-31
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