Senior Quality Assurance Associate Jobs in San Mateo, California

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

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.

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.

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.

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

• 2+ years of people management experience (required).

• 5+ years of experience working with quality management system (desired).

The Senior Quality Assurance Manager will:

• Bachelors Degree with relevant fields with 4+ years of medical device industry experience.

• A competitive salary and stock option plan along with a range of benefits

• opportunities for continuing education.

Participate in product design review with product managers, software engineers, and other stakeholders to contribute to product design, testability, and implementation.

5 years of experience working in a complex, matrixed & dynamic organization.

4 years of experience in Software development, coding, developing test automation using Python, or Java or C#.

3 years of experience in building and scaling test automation for web based applications using Javascript or Typescript.

4 years of experience in developing test methodologies, writing test plans, creating test cases, and debugging.

Experience with at least one automated test framework like Cypress, Playwright, or Selenium Webdriver.

• May work with management to update job training matrix.

• May track and report deviation QC trends to management.

• Coordinates and schedules all assigned quality control projects with minor assistance from coworkers and manager.

• Participates in continuing education through self-study, attending training sessions and lectures and meetings.

• Supports safety, quality, and 5S requirements and initiatives.

• Complies with company's procedures and regulatory requirements, as applicable.

Monitor routine manufacturing operations for conformance to applicable procedures (see Gowning Qualification requirements below)

Sample and perform visual inspection of final products and raw materials. Perform other testing under the direction of QA Operations Manager

Transfer materials between facilities (see lifting requirements below)

Required experience in GMP and FDA regulated environments (ISO 13485:2016preferred)

1 year experience in regulated industry highly desirable

Perform line clearance activities and in-process inspections

Communicates confidently and effectively with management, peers, and key stakeholders.

Creates and reviews risk management documentation to reduce or eliminate risk.

Minimum 5 years In Quality or related field experience; Less experience may be appropriate with advanced degree.

Career development with an international company where you can grow the career you dream of.

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

An excellent retirement savings plan with high employer contribution

Work with Department management to assign personnel and training materials to the appropriate Job Roles/curricula in Veeva

Interact with internal customers at various management levels to provide customer service

Manage GXP central filing system

Support Quality Control data entry processes

Minimum of 1-3 years of experience in a pharmaceutical and/or biotech company.

Advanced computer capabilities including all MS Office products

5+ years experience as QA Engineer or Test Automation Engineer

Excellent scripting skills in JavaScript

Experience using Selenium, JMeter, and Postman

Experience using and testing Single Page Applications

Experience using JIRA and TestRail

Experience with load and performance testing

Minimum of 5 years of experience in quality management

Prior experience in a quality management system within a manufacturing environment. Preferably ISO9001 and ISO13485

Ensures all sites meet quality management standards of ISO9001 and ISO13485. Manage site audits.

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

Prior experience in support internal and external audits

Knowledge of robotic liquid handling or comparable complex scientific lab equipment

Excellent problem-solving skills and experience with root cause investigations and CAPA determination

Knowledge of U.S. and international regulatory standards and guidelines

Strong computer skills including MS Office (Word, Excel)

Experience with rare diseases, neuromuscular diseases and/or gene therapy products

Experience in a small company and high growth, fast-paced environment

Perform review and approval of master production batch records.

Management of multiple quality system processes including, but not limited to, change control, deviation/CAPA management, and internal auditing.

Support and train on Quality Management Systems as needed.

Understand and comply with ethical, legal, and regulatory requirements applicable to our business.

5+ years of GMP quality experience in a biologic, Active Pharmaceutical Ingredient, or Drug Product manufacturing environment

Good working knowledge of associated industry and regulatory guidance documents; FDA guidelines, ICH Q7, 21 CFR Parts 210 and 211

Good working knowledge of cGMP and regulatory standards as they pertain to Drug Product and/ or API manufacturing.

Uses complete understanding and wide application of technical concepts, standards,and practices in chosen field and is expanding knowledge or related disciplines

Full knowledge of industry standards and Good Lab Practices

Applies analytical skills and independent judgment to develop innovative, practical, and consistent solutions to a wide range of complex problems

Working knowledge of U.S. and international regulations (QSR, ISO, GLP, cGMP)

Experience working under pressure, prioritizing, and multitasking quality issues in real-time

Excellent oral and written communication skills

Experience with us of ethylene oxide and at least one additional sterilization modality (e.g. radiation, moist heat, dry heat)

Good interpersonal and organizational skills.

Experience with GMP audits, internal and relevant external audits

Experience with overseeing biocompatibility studies

Work directly with the BWI R&D teams to validated and transfer break-through technologies to enable future growth and innovations.

Drive selection of sterilization modality, validation approaches and validation of the sterilization process for new products, and the sites for execution.

Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data

Support QA management to ensure product quality and compliance with cGMPs .

Familiar with ISO 9001, FDA QSR requirements

Exceptional written and verbal skills

Typically requires 2 years of related experience.

The estimated pay scale for the Quality Assurance Associate role based in Vista, CA is $23.52 - $35.28/hour depending on experience

Timeline management and experience using internal and external resources to achieve objectives.

Experience in inspection readiness and management.

Develop and reports Key Performance Indicators to measure CMO and Labeler performance and for contribution to Management Review.

Analytical and problem-solving skills; experience in root cause analysis.

Develop and use Quality Agreements to manage vendor activities, outputs and records.

Solid experience working within US and EU GMPs.

Requires proficient knowledge of job area typically obtained through advanced education combined with experience. May have practical knowledge of project management.

Perform product inspections in accordance with the applicable specifications/ drawing requirements and review supporting assembly instructions.

Experience in micro circuits and/or circuit card assemblies

Experience evaluating complex electronic hardware, under magnification, to IPC-J-STD-001 and/or NASASTD-8739 is required.

Certified, or the ability to obtain certification to the above referenced workmanship standards

Experience with engineering drawing review and interpretation

At least 6 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.

Advanced knowledge of cGMP regulations and FDA/EU guidance related to biologics or cell and gene therapies.

Demonstrated experience directly supervising employees.

A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.

Main responsibilities will include, but are not limited to:

Collaborate with business partners and provide meaningful guidance to help facilitate resolution of issues across organizational boundaries.