Quality Assurance Associate II
6701 Kaiser Drive Fremont, CA 94555
Bayside Solutions is seeking a Quality Assurance Associate II to be part of our client’ s team in the Fremont. 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:
- Works independently to provide quality assurance oversight of any area assigned where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs) including Quality Control Systems and areas.
- Demonstrates a high level of independent judgment and discretion in the timely identification, investigation and resolution of events impacting the Quality of products and processes.
- Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA)/Deviation management, impact assessments for changes to equipment and processes, risk management, and ensuring documentation and investigations meet all requirements.
- 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 equipment, systems, or areas.
- Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls. This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business.
- Performs independent technical review of documentation during and post-execution of cGMP activities.
- Ensures all specifications are met and that applicable requirements are completed and acceptable.
- Ensures all issues/documentation associated with each process in assigned area have been resolved and approved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures.
- Analyzes and reports findings to appropriate departments.
- Bachelor’ s degree in Life Sciences or Engineering
- Some Team Lead and/or Supervisory experience.
- Attention to detail, good organizational and interpersonal skills, and problem solving skill.
- Ability to prioritize and work under pressure.
- Ability to work effectively and to respond quickly in a fast paced environment.
- Knowledge of SAP, MS Word and Excel.