Quality Infrastructure Training Specialist
300 Bel Marin Keys Boulevard Novato, CA 94949
Bayside Solutions is seeking a Quality Infrastructure Training Specialist to be part of our client’ s team in Novato. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Quality Infrastructure Training Specialist:
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Scan and record training records.
- Review documents for GDP compliance, track movement of documents, manage corrections Assign training curricula.
- Maintain and update training database.
- File electronic and hard copy training records.
- Implementation of specific training and development initiatives.
- Training effectiveness improvement projects.
- Assist in the management of qualifications for trainers’ database.
- Assist in the design and build of QA curricula.
- Perform organizational and administrative tasks in the Learning Management System.
- Maintain the system for tracking and evaluating training compliance and analyze training trends.
- Distribute training related communications via memos, schedules, reports, BioWeb, etc.
- Ensure completion of department annual GMP training and perform GMP training as necessary.
- Review and understand documents (SOPs) related to training functions for multiple sites.
- Review and revise training related materials for current practices and applicable organizational changes as directed.
- Participate in lean improvement activities involving safety, compliance, accuracy, and efficiency.
- Participate in interdepartmental training initiatives.
- Participate in internal and external audits and inspections as needed.
- Comply with cGMP Documentation & Operations.
- Comply with safety guidelines
Summary of Qualifications:
- BA or BS in a technical discipline preferred (biological sciences preferred but not required).
- 2+ years experience in a GMP regulated environment, preferably with knowledge or proficiency in quality control.
- Organizational skills to coordinate multi-discipline projects.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Proficiency with standard office software applications, including MS Word, MS Excel, MS Power Point.
- Experience and proficiency with Learning Management Systems software such as ComplianceWire a plus.
- Understanding and familiarity FDA & European regulatory requirements, guidelines, and recommendations.
- Proficient organizational, spelling, grammar, and typing skills.
- Understanding of complex systems.