Quality Systems Support Associate
300 Bel Marin Keys Blvd Novato, CA 94949 | Contract
Bayside Solutions is seeking a Quality Systems Support Associate to be part of our Client’ s team in Marin County. This is an opportunity to work with a local Biopharmaceutical company focusing on the developing and commercializing novel therapies for rare diseases.
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. Their company has been recognized as one of the fastest drug developers in the industry and has also been recognized among the Top 10 World’ s Most Innovative Company’ s in 2015 & 2016.Their organization is fueled by their employee’ s passion and dedication to change the course of disease.
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.
Quality Systems Support Associate
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- 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:
- Review and closure of QC discrepancy reports within specified timelines: EM excursions, laboratory deviations, laboratory investigation reports, out of specification/trend reports.
- Provide technical expertise and knowledge to QC support group in determining root causes and developing effective CAPAs.
- Reviewing compendial updates and evaluating current QC practice compliance.
- Providing departmental metrics.
- Assisting with the closure of departmental Change Requests.
- Training record GDP review and resolution.
- Assist in the investigation of training discrepancies.
- Support the FVIII production/project for deviations, discrepancies and training item build for QC.
- Record entry into Learning Management Systems.
- Assist with the development and administration of the training system for QC groups.
- Associates degree or higher with a minimum of 5 years’ experience with GxP environment.
- Excellent with writing and reviewing skills.
- Knowledge of discrepancy records (deviations, laboratory investigation reports, out of specification, out of trend) for assignable root cause, development of appropriate CAPAs, and evaluation of CAPA effectiveness a plus.
- Knowledge of Learning Management Systems and other QC information systems (such as Trackwise, ComplianceWire, document control systems).
- Experience with compendial updates and compliance.
- Meticulous record keeping skills, excellent attention to detail.
- Knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies a plus.