ALS
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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
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 : 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) and EDMS/eQMS. Document lifecycle management (creation, revision, approval, archival). Understanding of change control, document numbering, version control, and traceability. Proficient verbal and written communication, strong organizational skills and attention to detail. Ability to adapt to changing priorities and maintain regulatory compliance awareness. Knowledge of retention policies and records archiving; ability to train or support users in document control processes. Occupational Health & Safety Responsibilities
Follow all company operating procedures, standards, policies, and training to ensure safe and efficient operations. Contribute to the ALS safety program by reporting unsafe acts and conditions to create a zero-injury environment. Participate in and support HSE initiatives as required by ALS leadership. Understand and apply precautions when working with chemicals and unknown hazards; use PPE as required. Ensure health and safety of staff, contractors, and visitors by providing leadership, resources, training, and enforcement onsite. Monitor and enforce HSE policies and ensure regulatory compliance. Promote awareness of policies and participate in all OHS initiatives; lead by example. Report injuries and incidents and assist with investigations per company policy. Ensure sites adhere to environmental requirements per government legislation and company policy. Quality Responsibilities
Ensure business is conducted in accordance with Core Values: Safe, Resilient, Curious, Committed, Caring, Honest. Adhere to Quality Systems in performance, review, and reporting of laboratory duties; communicate quality issues. Support Quality Department and Continuous Improvement Processes. Contribute to improving the ALS experience through effective communication. Forecast potential risks and establish contingency plans; ensure statutory management and reporting requirements are met. Ensure continuous improvement of the Quality Management System. Other Requirements
Working at a computer up to eight hours per day; sit/stand for extended periods as needed. Ability to sit, stand, bend, push, pull, stoop, and crouch up to 50% of the time; lift up to 25 lb. 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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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 : 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) and EDMS/eQMS. Document lifecycle management (creation, revision, approval, archival). Understanding of change control, document numbering, version control, and traceability. Proficient verbal and written communication, strong organizational skills and attention to detail. Ability to adapt to changing priorities and maintain regulatory compliance awareness. Knowledge of retention policies and records archiving; ability to train or support users in document control processes. Occupational Health & Safety Responsibilities
Follow all company operating procedures, standards, policies, and training to ensure safe and efficient operations. Contribute to the ALS safety program by reporting unsafe acts and conditions to create a zero-injury environment. Participate in and support HSE initiatives as required by ALS leadership. Understand and apply precautions when working with chemicals and unknown hazards; use PPE as required. Ensure health and safety of staff, contractors, and visitors by providing leadership, resources, training, and enforcement onsite. Monitor and enforce HSE policies and ensure regulatory compliance. Promote awareness of policies and participate in all OHS initiatives; lead by example. Report injuries and incidents and assist with investigations per company policy. Ensure sites adhere to environmental requirements per government legislation and company policy. Quality Responsibilities
Ensure business is conducted in accordance with Core Values: Safe, Resilient, Curious, Committed, Caring, Honest. Adhere to Quality Systems in performance, review, and reporting of laboratory duties; communicate quality issues. Support Quality Department and Continuous Improvement Processes. Contribute to improving the ALS experience through effective communication. Forecast potential risks and establish contingency plans; ensure statutory management and reporting requirements are met. Ensure continuous improvement of the Quality Management System. Other Requirements
Working at a computer up to eight hours per day; sit/stand for extended periods as needed. Ability to sit, stand, bend, push, pull, stoop, and crouch up to 50% of the time; lift up to 25 lb. 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.
#J-18808-Ljbffr