Quality Control Equipment Qualification Specialist
1 Antibody Way Oceanside, CA 92056
Bayside Solutions is seeking a Quality Control Equipment Qualification Specialist to be part of our client’ s team in Oceanside, Ca. 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.
QC Equipment Qualification 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:
- Support site training for “ standard systems” during the rollout
- Work with sites to build Standardized URS and IOV documents as dictated by equipment type.
- Creation of “ current state” to document how sites are doing qualification. Creation of “ future state” benefits going forward (new way of doing business)
- Work to revise Global Standard Document documents to align with the new processes governed.
- Creation of repository of necessary supporting documents such as Supplier Assessments.
- Work closely together with development and other QC technology groups to ensure that new technologies are well document so that other sites can adopt the qualification strategy of these new technologies.
- Lead Global teams to bring together all groups impacted by “ Standard systems” such as Quality Control, Manufacturing, Development, and Computer System Validation.
Summary of Qualifications:
- Bachelor or above in Life Science, Pharmacy or equivalent
- Relevant experience in GMP environment for Biologics or Small Molecules.
- Experience in Equipment Qualification and/or Computer Systems Validation.
- Experience in analytical technologies a plus
- German Language is a plus
- Ownership and Accountability - Takes accountability for actions, drives results, learns from mistakes. Is direct and truthful and therefore widely trusted - delivers on promises, goals, and expectations. Makes quality decisions and resolves problems rapidly.
- Customer Focus - Partners with customers/stakeholders and looks ahead to predict future stakeholder needs.
- Decision Making – Demonstrates sound judgment in synthesizing data and information to make timely decisions; communicates, influences and escalates issues and decisions as needed.
- Teamwork & Communication – Contributes to an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation.
- Up to 20% Travel maybe necessary for this position.