Quality Assurance Associate II
6755 Kaiser Dr Fremont, CA 94555
Bayside Solutions is seeking a Quality Assurance Associate II 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.
QA Associate II
- 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:
- This position is responsible for ensuring compliance and providing QA oversight of site according to cGMP regulations. Also responsible for implementing, maintaining, and monitoring Quality processes necessary for that assurance. This includes overseeing junior team members, executing operations according to cGMP regulations, and identifying and implementing business process improvements that will drive business performance and Quality innovation.
- With autonomy and authority, makes difficult decisions with little time for deliberation which may have a direct impact on active manufacturing operations, the release of product, equipment, systems, or areas.
- Requires strong interfaces with all functions in network. Key functions are Manufacturing, E&T, PS, and Quality.
- Responsible for supporting batch disposition activities of internal and client products by review of batch deliverables (CoA, deviations, change controls).
- Support and represent Quality with clients on project teams. Support manufacturing readiness with oversight of batch records, specifications, protocols. Required to communicate with clients, external vendors and external services to resolve issues.
- Responsible for providing quality oversight of quality systems for deviations, CAPAs and change controls. Identifies, classifies and reports minor and major deviations. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with others to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations.
- Assess Quality documents and processes for continuous improvement opportunities.
- Bachelor' s Degree in relevant Life Sciences discipline.
- Minimum of 6 years of relevant work experience in Quality in a highly regulated pharmaceutical environment.
- Strong communication, interpersonal and problem-solving skills.
- Detail-oriented and resourceful.
- Ability to prioritize and work under pressure to handle multiple timelines.
- Able to work independently and collaborate in a team setting.
- Demonstrate ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
- Proficiency with MS Office products (Word, Outlook, Excel, PowerPoint), SAP, TrackWise