Quality Systems Specialist
6755 Kaiser Dr Fremont, CA 94555
Email VMS@baysidesolutions.com, to connect with Eli & team members for approval prior to submitting into wand and client submitting into bullhorn
Please do not submit higher than the provided rate.
Bayside Solutions is seeking a Quality Systems Specialist to be part of our client’ s team in the East Bay. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients’ lives.
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 Systems 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:
- Manage risk review tracker by adding relevant deviation and change control information to excel spreadsheet; filter risk review data to provide details required for regularly occurring risk review meetings
- Schedule risk review meetings, prepare agendas, take notes, and post meeting minutes in a timely manner; follow-up on action items and report progress to QRM manager
- Prepare risk communication slide decks and work with Management Review system owner to include QRM topics in the management review agenda
- Work with Document Management System coordinators and Risk Assessment Owners to retire Quality Risk Assessment reports for inactive projects
- Schedule Periodic Review meetings for active projects, prepare agendas, take notes, and post meeting minutes in a timely manner; follow-up on action items and report progress to QRM manager
- Proactively manage QRA summary report status tracking spreadsheet to support QRM manager in resource planning and project schedule commitments
- Schedule QRM Instructor-led training sessions, document attendance, and interface with managers and employees requesting QRM training (QRM manager provides the training)
- Schedule Site RA meetings, prepare questionnaire / excel templates, take notes, and post meeting minutes in a timely manner; follow-up on action items and report progress to QRM manager
- Develop MS Teams site for QRM; transfer relevant files from share room to the MS Teams app and monitor incoming posts for action by QRM manager
- Maintain QRM share room to the extent needed to support the transition to MS Teams; this includes maintaining current and accessible QRM files (e.g. presentations, training materials, templates, WIP folders for risk assessments)
- Develop QRM Biowiki page; make accessible to internal customers and manage link with QRM MS Teams site
- Interface with Product Project Managers and Risk Assessment Owners to assure clarity and synergy in relation to QRM deliverables and project timelines
- Support inspection readiness activities as assigned (e.g. querying, downloading, and printing requested GMP documentation; collection and formatting of data for SME review / presentation)
- Support for Document Management, Data Integrity, and Management Review systems as assigned
- Support for Supplier Quality, Change Control, Deviation / CAPA, and Training systems as assigned
- Bachelor’ s degree from an accredited institution, preferably in a related concentration (such as life sciences) plus five (5) years of biotech / pharma professional experience with cross-functional support to other cGMP areas.
- This position requires a person who is organized, hard working with a productive work ethic.
- The individual should be able to make sound decisions and manage tasks and priorities in alignment with department goals and objectives.
- The individual will communicate clearly and professionally in both verbally and written forms.
- A person with well-developed interpersonal skills and the ability to maintain highly functional relationships with diverse personalities is necessary.
- A solid knowledge of cGMP and a compliance mindset are critical; familiarity with ICH Q9 and ISO 14971 risk management principles is preferred
- Strong independent judgment and decision-making abilities required.
- Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
- Proficient with core MS applications: Word, Excel, PowerPoint (Visio a plus)
- Familiarity with collaborative MS tools: SharePoint and Teams (with ability to build upon existing knowledge to become proficient in short time)
- Familiarity with Quality Systems tools, or equivalent applications: TrackWise, Documentum, SAP, Veeva, etc. (minimum of read-only access)