Sutro Biopharma, Inc. is seeking a professional to be part of the Quality Operations (QO) group. This group is responsible for establishing/updating/executing cGMP Quality Operation activities including Change Control, Deviation Management, CAPA Management and Line Clearance in support of reagents, XtractCFTM and XpressCFTM material manufacturing. This individual will be assisting Quality Organization strategies to establish a robust cGMP facility in San Carlos, CA.
The Senior Quality Assurance Specialist is also a hands-on QA professional capable of performing tactical tasks. The Senior Quality Assurance Specialist reports to the Sr. Manager, Quality Operations.
This individual will be responsible for supporting Quality Operations (QO) in Sutro Biopharma’s cGMP Manufacturing Facility and will, at a minimum, include:
- Drive initiation, execution, closure and trending of Change Controls, Deviations, CAPAs and Line Clearances in support of San Carlos Manufacturing Operation.
- Conducting Quality reviews of production documentation, including production batch records, analytical records and any supporting documentation to ensure compliance with cGMPs and Sutro policies and procedures, and in some cases prepare disposition documentation.
- Performing routine reviews of all cGMP documentation, to include laboratory notebooks, equipment logs and facility monitoring reports. Additionally, create and/or utilize various databases to track compliance issues and their resolution.
- Providing QA support during manufacturing operations, which may include shift coverage.
- Assist with investigation and resolution of cGMP or procedural compliance gaps, as well as work with staff from other departments to resolve compliance issues found during the Quality reviews.
- Assist with training of personnel, to ensure compliance and conformance to Sutro’s requirements.
- Assist with Quality audits of internal departments, as well as external potential and/or current vendors, contract organizations and regulatory authorities.
- Develops, applies, revises and maintains quality assurance protocols/methods/procedures for processing materials into partially finished or finished products.
- Designs methods/procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
- Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- May assure compliance to in-house and/or external specifications and standards, (i.e. GLP, GMP, ISO, Six Sigma).
- May assist/support activities as it applies to regulatory filings (BLAs, INDs and CTAs).
- May assist/support in Quality Systems activities including Documentation Control, Training Supplier Management and Raw Material/Product Release.
This individual will be expected to effectively follow Sutro Biopharma’s SOPs and policies, and cGMP compliance regulations. Additionally, he/she should be able to independently manage review times to meet Sutro’s priorities and communicated timelines.
This individual may be asked to travel on behalf of Sutro Biopharma to support business operations that involve contract manufacturing. Anticipated travel is approximately 5-20%.
- 3-6 years of Quality Assurance related experience in a cGMP regulated manufacturing environment is required
- Bachelor’s degree or higher in a relevant scientific area is strongly preferred
- Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
- Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
- Results self-driven with a “can do” positive attitude
- Knowledge and ability to sufficiently train others on regulatory compliance issues
- Strong interpersonal skills and ability to work with others in a positive and collaborative manner
- Strong verbal and written communication skills essential
- Strong communication, prioritization and organizational skills
- Knowledge of cGMP concepts and guidelines, as well as good documentation practices
- Ability to utilize multiple word-processing and database applications. Experience with contract manufacturing operations is a plus.
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, and stock options.