Document Control and Training Associate

PBS Biotech • Camarillo, CA

3d • $20 - $26 • Onsite

About The Position

PBS Biotech is seeking a part-time Document Control and Training Associate contractor to support our Quality team at our Camarillo facility. This temporary contractor position offers a flexible schedule of up to 20 hours per week, making it an excellent opportunity for a college student, an individual re-entering the workforce, or an experienced professional seeking meaningful part-time work. In this role, you will support 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.

Requirements

• 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.
• 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)

Nice To Haves

• Quality Management System (QMS) and electronic Quality Management System (eQMS) is a strong plus.

Responsibilities

• 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.

Benefits

• Flexible schedule

What This Job Offers

• Job Type: Part-time
• Career Level: Entry Level