Senior Quality Assurance Associate Jobs in California

Provide knowledge regarding QA concepts, methodology, best practices, tools and metrics.

Write, manage, and continuously re-evaluate test plans to adjust for new information and project schedules.

Assess projects to identify QA requirements and identify areas for improvement.

Excellent critical thinking and problem-solving abilities.

College Degree or equivalent experience required.

Experience testing ecommerce websites, responsive designs and mobile applications.

Experience in in the areas of Clinical Quality Assurance, Supplier Quality Management, External Manufacturing Oversight, or Cell Therapy a plus!

Report quality system and supplier performance metrics to Quality Management Review.

Minimum 8+ years of relevant experience including pharmaceutical/biotechnology industry and Quality Assurance experience.

Excellent understanding of GxP requirements with focus on FDA and EMA

Excellent verbal and written communication skills

Generate and maintain Quality Assurance procedures and programs, ensuring alignment with FDA and EMA regulatory expectations.

Proficient in MS Office applications and document management systems, TrackWise experience an asset

Document Management in TrackWise Digital, including document formatting, managing TrackWise workflows, and end-user support

0-2 years of GxP relevant experience

Excellent verbal and written communication skills

Strong organizational skills and attention to detail

Perform QA review and data audit for technical reports and other IND-enabling source documentation

You are an experienced leader who thrives on mentoring and leading others.

Oversee maintenance of current federal and state clinical laboratory accreditations, licenses, certifications, and permits.

You have a minimum of 5 years of experience in Quality Assurance/Systems in a CLIA laboratory environment.

Knowledge of LDT in a CAP-accredited and CLIA-certified laboratory is highly preferred.

Senior Manager of Quality Assurance

You work well as part of a cross-functional team and are highly adaptable to working in a fast-paced, matrix environment.

Strong technical writing and communication skills.

Work with other engineering functions for product design, development, verification, and validation.

Support the application of quality engineering/compliance of various functions and levels with technical responsibility or strategic input.

Identify and provide direction for statistical support in both design and routine manufacturing activities for achieving required levels of product reliability.

Lead the investigation, resolution, and prevention of product and process non-conformances.

Develop and conduct training when needed.

5. Experience with a Food Safety Management System in the role of Manager or Supervisor

· Program Management of all Quality Programs, e.g., cGMP, HACCP, CAPA, CCOF, Controlled Documents, Audits, etc.

· Acts as a secondary practitioner for the company’s Food Safety Management System.

· Performs audits and reporting of issues within the company’s Food Safety Management System

· Manages third party laboratory testing requirements.

3. Three (3) years of experience as a QA Laboratory Manager and/or Supervisor; AND

·2+ years of Quality Control experience in a manufacturing environment (preferred)

· Knowledge of Sanitation GMP, HACCP, SSOP

· Demonstrates experience in the food processing environment, encouraging food safety culture with coworkers.

· Experience working under Health Department and FDA guidelines.

· Team building/team leadership skills.

· Computer skills, including Office, Excel, and PowerPoint.

Bachelor's Degree or equivalent combination of education and experience.

5-8 years of QA experience of both web application and web service testing.

3+ years’ experience with running and developing automated test scripts.

S Degree (engineering preferred) or significant equivalent experience.

Experience developing automation code in Selenium, C#.

Experience creating, executing, and reviewing results of functional, integration, and regression testing.

Knowledge of Quality Management Systems; experience in implementing and managing quality systems (paper based and Veeva EDMS) in the pharmaceutical industry.

Support the implementation of GMP and GLP activities as required by internal procedures and application of regulatory requirements.

Minimum 10 years of GMP Quality Assurance experience with GLP experience a plus.

Strong understanding of small molecule manufacturing with direct experience in solid oral dosage forms.

Knowledge in clinical development to commercial is desired.

Hands-on experience in manufacturing and/or analytical testing and development.

0-2 years of experience is typical to meet the skills and responsibilities of the position.

Knowledge of quality management techniques and application;

Utilize quality management techniques to perform investigations and facilitate solutions.

Bachelor's degree, or an equivalent combination of education and experience (in lieu of a Bachelors)

Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices;

Ability to quickly gain knowledge, understanding or skills and is willing to learn.

Effective interpersonal skills for collaborating effectively with a broad range of managers and staff and with representatives of external regulatory agencies.

Thorough knowledge and understanding of compliance and regulatory standards across the healthcare industry or within a specialty area including pharmaceutical QMS.

Demonstrates working knowledge of quality assurance systems, methods and procedures.

Must be able to maintain confidentiality.

Must be able to work various hours and locations based on business needs.

UCSD Layoff from Career Appointment

Support Management Review activities and oversee trending of key quality, product and GMP metrics.

Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.

Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.

Bachelor's Degree and 3 + years of experience in a GMP environment.

Knowledge of and ability to apply GMP in conformance to US, EU and ROW standards.

Proficient in cGMP regulations, quality systems and regulatory requirements.

Scientific BG, don’t need to have experience, they will be trained

Screening complaints record and processing the records per Standard Operating Procedure (SOP) requirements

• Experience in the healthcare/device industry or exposure to medical device quality system regulations is preferred.

Prior experience processing medical device or drug complaints preferred.

Schedule: 8am - 4:30pm with some flexibility

Complaint handling - Mostly closing complaints, fielding complaints