Senior Quality Assurance Specialist

Sutro Biopharma, Inc.
is looking for 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 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.
While collaborating with cross-functional departments, you will play a key role in maximizing our technology and progressing our novel therapeutics.
We are dedicated to making a difference in the lives of patients, both as individuals and as part of a team.
Responsibilities: This individual will be responsible for supporting Quality Systems (QS) in Sutro Biopharma’s cGMP Manufacturing Facility and will, at a minimum, include: 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.
Drive initiation, execution, closure and trending of Documentation Control, Training and Compliance activities in support of San Carlos Manufacturing Operations.
Subject Matter Expert (SME) on Documentation Control platforms such as Master Control to drive efficiency and maximum utilization of the system.
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 support partner and/or regulatory authority audits.
Develops, applies, revises, and maintains quality system protocols/methods/procedures.
Perform cGMP documentation issuance, reconciliation, and archival according to policies and 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.
Qualifications: 5+ years of Quality Assurance/Quality Systems and/or Compliance 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.
Sound exciting? Apply today and join our team! Sutro Biopharma, Inc.
requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment.
As required by applicable law, Sutro will consider requests for reasonable accommodations.
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.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions.
Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team.
Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability, or citizenship status.
We are dedicated to creating a safe environment where our employees can grow and succeed together.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California-based locations will be [110,000-125,000] (not including bonus, equity, and benefits).
The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.
About Sutro Biopharma Sutro Biopharma, Inc.
, is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, transforming what science can do for patients.
Sutro’s fit-for-purpose technology, including cell-free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience.
Sutro has multiple clinical-stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FolRα)-targeting ADC in clinical studies.
A robust pipeline, coupled with high-value collaborations and industry partnerships, validates our continuous product innovation.
Sutro is headquartered in South San Francisco.
For more information, follow Sutro on social media @Sutrobio, or visit www.
sutrobio.
com.