Senior Quality Assurance Specialist, Quality Systems & Compliance
We are seeking a professional to be part of the Quality Systems & Compliance group. This group is responsible for establishing/updating/executing cGMP Quality Systems & Compliance activities including Documentation Control, Training and Compliance in support of reagents, XtractCFTMand XpressCFTMmaterial manufacturing. This individual will be assisting Quality Organization strategies to establish a robust cGMP facility in San Carlos, CA.
- Responsible for supporting Quality Operations (QO) in Sutro Biopharma’s cGMP manufacturing facility
- Subject Matter Expert (SME) on Documentation Control platforms such as Master Control
- Drive initiation, execution, closure, and trending of Documentation Control. Training and Compliance activities in support of San Carlos Manufacturing Operations.
- 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.
- 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 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 support partner and/or regulatory authority audits.
- Develops, applies, revises, and maintains quality system protocols/methods/procedures.
- 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 in Quality Operations activities including processing change controls, deviations and CAPAs.
- Effectively follow Sutro Biopharma’s SOPs and policies, and cGMP compliance regulations.
- Independently manage review times to meet Sutro’s priorities and communicated timelines.
- May be asked to travel on behalf of Sutro Biopharma to support Quality Systems and/or Compliance initiatives. Anticipated travel is a minimal 0-10%.
- 3-5 years of Quality Assurance/Quality Systems and/or Compliance related experience in a cGMP regulated manufacturing environment is a requirement.
- 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.
- Ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
- 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
- Strong 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, ESPP (Employee Stock Purchase Plan) and stock options.
Sutro Biopharma is committed to the diversity of our team and we are committed to Equal Employment Opportunity without regard for race, ethnicity, gender, protected veteran status, disability, sexual orientation, gender identity or religion.
Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma. Please be advised, inquiries or resumes from recruiters will not be accepted.