QA Specialist I
500 Forbes Blvd., SSF56 South San Francisco, CA 94080
Bayside Solutions is seeking a QA Specialist I to be part of our Client’ s team in South San Francisco. 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.
QA Specialist I
- 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:
- Familiar with Quality System for change control and document management functions for GMP changes involving equipment, document, test methods, processes and specifications for IMP Small Molecule and Biologics.
- Manage workflow through Trackwise and EDMS to ensure timely release of systems and documents.
- Proactively identify, prioritize and assess quality systems compliance risks across the IMP network.
- Manage Quality System for discrepancy and CAPA management for IMP customers.
- Perform routine Quality trend analysis of IMP discrepancies and audit of incident discrepancies.
- Manage workflow through Trackwise discrepancy and CAPA systems.
- Assist with GMP self-inspection program for IMP manufacturing and testing areas including:
- Maintenance of self-inspection audit plan and schedule.
- Coordination of self-inspection audit with other subject matter experts.
- Issue audit reports and track corrective action from audits.
- Communicate to PTDQ-U leadership regarding compliance status.
- Maintain list of approved contract testing laboratories and corresponding Quality Agreements.
- Participate in lab audits as needed.
- Mentor and supervise (as required) other Quality System staff members on Change Control, Discrepancy, CAPA, Self-Inspection, Quality Agreements and/or other related processes and projects.
- May be requested to take on challenging assignments as an Individual Contributor (working with complex cross functional global teams).
- Ensure proper department policies and procedures are in place to execute QS&C functions.
- Provide input into the design and presentation of department performance metrics.
- Must be willing to train team members on specific assignments based on core experience.
- Participate on Ad Hoc teams not related to primary role and responsibilities.
- Provide input to the development of personal performance goals and departmental objectives.
- Collaborate with Management to establish and meet targets and timelines
- B.A., B.S., M.S degree (preferably in Life Science or Engineering) and at least 5 years’ experience in the pharmaceutical, biopharmaceutical, device/combination or related industry, or an equivalent combination of education and experience.
- Several years’ experience working with simple to complex Quality System software (Trackwise, SAP, LIMS).
- Strong with MS Office Suite (Word, Visio, Excel).
- Familiar with Google Docs.
- Basic knowledge of US, EU and global cGMP requirements.
- Experience supporting production and testing of investigation medicinal products (IMPs).
- Strong background in Quality Systems for IMP, Biologic and Combination products.
- Ability to interpret and relate Quality Standards for implementation and review.
- Proven record of applying Quality, Compliance and Risk concepts to make sound technical decisions.
- Ability to make sound decisions about scheduling, allocation of resources, and managing priorities.
- Ability to communicate clearly and professionally both in writing and verbally.