QC Associate II
6701 Kaiser Drive Fremont, CA 94555
Bayside Solutions is seeking a QC Associate II to be part of our client’ s team in Fremont. 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 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:
- Executes and coordinates routine and non routine testing in QC of bulk drug substance and drug product in a multi-product facility.
- Executes independently with adequate training fundamental operations such as biochemistry, drug product device testing, UV-vis absorbance, gel electrophoresis, pH, Osmolalilty
- Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
- Delivery of high quality analytical results within timeline right the first time
- Documents work according to cGMP and cGDP.
- Adheres to established regulations and follows cGMP established by site. Reports abnormalities and deviations in a timely and accurate manner.
- Adheres to safety standards and identifies unsafe situations / habits and escalates approriately.
- Maintains work production areas according to predefined standards (5s).
- Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
- Represents QC operations on cross-functional root cause analysis teams for deviations, CAPAs and risk assessments.
Summary of Qualifications:
- Bachelors' degree in Biology or Life Sciences required.
- 3-5 years of industry experience.
- GMP experience is highly preferred.
- Demonstrates strong interpersonal and communication skills (both written and oral), a strong customer focus, and an ability to interact with various departments and levels.
- Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals; is also able to work across functions to achieve common goals.
- Demonstrates strong attention to detail, and an ability to focus on details of execution.