300 Bel Marin Keys Blvd. Novato, CA 94949
Bayside Solutions is seeking a QC Technician to be part of our client’ s team in Novato. 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.
- 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:
- Organizes reviewed test records according to departmental policies.
- Organizes of documents for archival purposes.
- Receives samples for testing by the QC laboratory.
- Monitors laboratory equipment for calibration needs, maintenance and tracking of issues related to instrumentation.
- Communicates with QC Analysts, Associates, Management and consultants regarding critical equipment issues, events or deviations.
- Provides guidance to internal customers submitting samples for testing.
- Identifies testing requirements based upon predefined testing schemes.
- Manages elements of a Laboratory Information System (LIMS) for sample management and tracking.
- Support continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and sample management (cGMP, ICH).
- Work collaboratively with manufacturing/supply chain, quality assurance, regulatory, and project management to ensure timely availability of lot release, stability data, and other required analytical data.
Summary of Qualifications:
- BS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 0-2 years professional experience ).
- Relevant experience in a Quality Control function at a technician level is required.
- Experience with analytical systems (LIMS, laboratory control systems, stability/release systems) is required.
- Basic understanding of regulatory agency (FDA) requirement and international guidance (ICH) for drug substance and product under GMP is required as applied to biologics.
- Ability to effectively prioritize and deliver on tight timelines in a fast-paced environment.
- Excellent written and verbal communication skills.
- Experience in analytical data systems (Empower, LIMS) would be a plus.
- Accuracy and attention to detail.
- Excellent cross-functional team participation skills.
- Good problem-solving abilities.
- Ability to be flexible with changing work needs
- Interacts with other functional leaders, project management and QC/AD team personnel
- Interacts with Contract Testing Laboratories, Contract Manufacturing Organizations, consultants and external partners