Document Control Specialist
900 Island Dr, Suite 101 Redwood City, CA 94065 | Contract
Bayside Solutions is seeking a Document Control Specialist to be part of our client’ s team in Redwood City. 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.
Document Control 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:
- Develop, implement and manage reliable Document control System.
- Oversee all quality system documentation.
- Manage and maintain training compliance by initiating training plans, updating assessments as needed and conducting training sessions.
- Establish and maintain company Approved Supplier List.
- Generate quality system metrics such as ECO, Training, etc. for Management Reviews.
- Maintain external standards library.
- Perform documentation audit to completed BT/Traveler.
- Complete designated internal audits.
- Participate in agency audits (i.e. CA FDB, FDA, and ISO).
- Ability to use CAD (SolidWorks) to make simple redline changes to part drawings.
- May be required to cross train in other areas with the Quality Department to support workload required, e.g. Supplier Quality, Quality Inspection, CAPA, Complaints.
- Understands and practices the company Quality Policy.
- Maintains trained status for, and complies with, all relevant aspects of the company Quality Management Systems to ensure product quality and support regulatory compliance.
Summary of Qualifications:
- One year certificate from college or technical school; or two or three years related experience and/or training; or equivalent combination of education and experience.
- Basic working knowledge of CAD (SolidWorks) software.
- Basic knowledge of QSR documentation and records requirements.