Associate, Clinical Quality
300 Bel Marin Keys Blvd. Novato, CA 94949 US
This position reports to the Director / Supervisor/ Manager/ Senior Manager, Clinical Quality Operations and is responsible for quality oversight for processes relating to the development, manufacture and testing of clinical material made for the company
The responsibilities in the role include the following:
- Review of GMP documentation from Pilot Plant, CDMOs, Analytical Sciences, including log books, batch records and test records.
- Issuance of Batch Records for clinical production
- Review and approval of procedures and batch records related to early phase programs(Quality, Pilot Plant, Analytical Sciences, other areas).
- Review and approval of quality system records including change requests, deviations and CAPA for Technical Development (i.e. Pilot Plant, Analytical Sciences, Process Development).
- Oversee manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations.
- Bachelor's degree in scienfitic field.
- Minimum 3 years of experience in a Quality/Compliance/Regulatory setting
- Sound knowledge of cGMPs and equivalent industry regulations
- Prior experience with oversight of manufacturing or testing operations
- Proficiency with computer systems – Microsoft Office Suite
- Proficiency with database use for example Veeva or other QMS, Benchling or other ELN, LIMS, Oracle or other ERP preferred
- Collaboration - Ability to work across teams and individuals at various levels in the organization to complete work tasks and activities. Strong follow-up and an ability to relate well to others.
- Ownership and Accountability– Takes accountability for actions, drives results, and able to learn from mistakes. Delivers on promises, goals, and expectations. Makes quality decisions and resolves problems with minimal delay as appropriate. Asks “what can I do to help?”
- Communication- Ability to communicate effectively with peer and managers. Strives for simplicity. Ability to draft and deliver clear and concise written communications.
- Planning - Ability to prioritize and ask questions when priorities are not clear. Ability to adapt to changing deadlines and escalate when roadblocks occur. Able to deliver results despite shifting environment.
- Customer focus - Partners with customers, looks ahead to predict future customer needs. Manages expectations.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.