Quality Assurance Specialist - SGA Inc.

Software Guidance & Assistance, Inc., (SGA), is searching for a Quality Assurance Specialist for a Contract assignment with one of our premier Healthcare clients in San Francisco, CA .

Responsibilities :

• Applies research compliance professional concepts to review protocols to ensure that all regulatory criteria are met, as well as policies and/or regulations from the organization, the state, and systemwide.
• Routine implementation of quality systems including document management, supplier qualification, record review, report monitoring and tracking, deviation investigation, and other processes per established procedures
• Participates in the development and revision of standard operating procedures and guidelines.
• Draft and revise Standard Operating Procedures
• Communicates directly with investigators to resolve all concerns as identified during the review process.
• Perform internal audits. Ensure readiness for inspections by the FDA and audits from funders and collaborators.
• Participates in training of individuals and departments on relevant compliance processes, forms, and policies.
• Coordinate and maintain records of personnel training specific to cell therapy program operations
• Additional Tasks as assigned to ensure quality in cell therapy development and manufacturing activities.

Required Skills:

• At least five years' experience in a quality role in an FDA-regulated industry such as cell therapy, biotechnology, pharmaceuticals, or medical devices.
• Bachelor's degree in related area and / or equivalent experience / training.
• Independence, planning and decision-making abilities to complete assigned duties.
• Knowledge of relevant Federal and State regulations, and policies.
• Ability to solve problems, issues; listen, interpret and confirm understanding of others' communications; and be objective.
• Effective, efficient and tactful oral and written communication skills.
• Time management skills and the flexibility to accommodate changing priorities in unit.
• Ability to work in a team oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction.
• Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities.
• Strong organizational skills, the ability to multi-task, and work with frequent interruptions.

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com/ .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy. Salary:35.0-40.0 USD/Hour