QA Document Control Specialist 1Alsglobal • Torrance, CA, United States
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QA Document Control Specialist 1
Alsglobal • Torrance, CA, United States
Hace 6 días
Tipo de contrato
- A tiempo completo
Descripción del trabajo. 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 1Generic Position Code / Title : SCI25 / Quality CoordinatorBusiness Stream : Pharmaceutical and Beauty and Personal CareLocation : Torrance, CA USALine Manager : Quality Assurance DirectorDirect Reports : N / AFLSA Status : Non-ExemptPrimary 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 DCRS (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 : Minimum : Associates degree or equivalent. Preferred : Bachelors degree in a related field such as : Business Administration Quality Assurance / Quality Management Life Sciences or similar 24 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.) Electronic document control systems (EDMS / eQMS) Document lifecycle management (creation, revision, approval, archival) Understanding of : Change control and document numbering systems Version control and document traceability Controlled copy issuance and retrieval processes 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. Key Competencies : 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 Occupational Health & Safety Responsibilities : 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.Quality Responsibilities : 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.Other Requirements : 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.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, youll 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
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QA Document Control Specialist 1 • Torrance, CA, United States
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