- Support the company's efforts for cGMP qualification and ISO 9001:2015 certification.
- Support the day-to-day Document Change Management process including document formatting, template creation and management, document and record distribution, and archival when applicable.
- Help to manage document control processes and systems for compliance with internal procedures and policies as well as regulatory requirements, including updating and coordination with ERP system.
- Partner with identified staff in the creation and management of document format and content templates.
- Assist in managing the Periodic Review program to ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in the applicable procedures and adhere to the applicable regulatory standards.
- Help to maintain and enhance the records management systems including storage, retrieval, retention, and destruction.
- Help manage the storage of physical and electronic documents, including the creation of electronic copies, scanning records, manage incoming documentation and records, and record reconsolidation.
- Help maintain Training program.
- Send timely training notifications and follow-up.
- Monitor and support the creation and revision to Training job roles, curriculum, and training requirements.
- Assist in the management and enhancement of the electronic Learning Management System (LMS) and electronic document management system (EDMS). User navigation support.
- Maintain a state of inspection readiness and participate in inspection preparation activities.
- Support internal and external audits and inspection activities through retrieval and provision of requested Quality Management Systems records and data in a timely manner.
- Support QMS initiatives as assigned.
- Will be assigned additional tasks and projects as needed to meet business objectives.
- 1 year of experience within a role that requires a high degree of quality control, ideally GMP quality system, medical device (QSR/ISO13485), aerospace (AS 9100), ISO 9001, or other similar systems or equivalent education. e.g., Bachelor's Degree.
- Microsoft Office (Word, Excel, Power Point, Outlook) and PDF Fill-in-Forms.
- Strong verbal and written communication and presentation skills.
- Quality Management System (QMS) and electronic Quality Management System (eQMS) is a strong plus.
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Document Control and Training Associate - Camarillo, United States - PBS Biotech
Description
Job Description
Job DescriptionCompany: PBS Biotech, Inc
Department: Quality
Position/Title: Document Control and Training Associate
Location: Camarillo, CA
Reporting To: Dir. Quality Management
FLSA Status: Non-Exempt
Pay Range: $ $ $ Hourly
GENERAL PURPOSE
In accordance with the QMS and Quality Policy, the Document Control and Training Associate supports the accurate and efficient management of both paper and electronic documents retained within Document Control for PBS's Quality Management System (QMS), including supporting the Periodic Review program for impacted documents. Additionally, this position will support the timely execution and management of training tasks for all PBS staff, along with the required documentation as proof of training.
Experience with Microsoft Office (Word, Excel, Power Point, Outlook) and PDF Fill-in-Forms is required.
RESPONSIBILITIES
Essential functions of the job are listed below. Other responsibilities may also be assigned. Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location. Reasonable accommodation may be made to allow differently abled individuals to perform the essential functions of the job.
Primary Responsibilities
MINIMUM QUALIFICATIONS
The following are the minimum qualifications that an individual needs to successfully perform the duties and responsibilities of this position. Please note that the minimum qualifications may vary based upon the department size and/or geographic location.
Knowledge/ Experience
Skills/ Abilities Pertinent to This Position
PHYSICAL DEMANDS
In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to allow differently abled individuals to perform the essential functions of the job.
Must be able to see, hear, speak, and write clearly to effectively communicate with employees and/or vendors; manual dexterity required for occasional standing, reaching, and lifting of small objects. May occasionally be required to lift various weights up to 25lbs (<25lbs = 1 box of documents> as needed to meet job requirements).
WORK ENVIRONMENT
In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to allow differently abled individuals to perform the essential functions of the job within the environment.
This role is primarily office work with some tasks or evaluation performed in a production or lab-like environment. May occasionally be required to perform some tasks in the following environments: Cleanroom; near moving mechanical parts, fumes, machine lubricants, airborne particles, vibration, and risk of electrical shock, high noise while in the manufacturing plant; Personal protective equipment (vision and hearing) used in plant.
Company Description
PBS Biotech improves the lives of patients by providing scalable single-use manufacturing solutions to the cell therapy industry that enable broader access to novel regenerative medicines. The Vertical-Wheel bioreactor provides our customers with a truly scalable platform that is optimized for cell therapy manufacturing requirements, which streamlines their process development and accelerates their time to market.
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