Senior Quality Assurance Associate Jobs in Dallas, Texas

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.

Operate the ECO system within our electronic Quality Management System (eQMS)

Experience operating a change control system in a regulated environment (medical device, pharma, diagnostics) with five years of experience preferred

Strong verbal and written communication skills and interpersonal skills

Document Control including releasing approved documents and controlling revisions

Assisting other professionals with ECO creation

Routing ECOs and associated documents to the appropriate reviewers/approvers

Identifies and communicates substandard product performance or inadequate implementation of product requirements to engineering and management

Identifies, reproduces, and escalates new or persistent software or hardware related failure modes to management and appropriate Engineering teams

Represents department cross-functionally in meetings that may include engineers, management, and external personnel

Escalates to direct management all quality issues that could impact patient safety or surgical efficacy

Ensures successful, on-time completion of department projects; communicates constraints to direct management when successful project completion is at risk

Performs a broad variety of tasks in support of product and process design as assigned by department management

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

Relevant certifications and/or experience may be substituted in lieu of this requirement

Assist the site QAS in collaborations, including problem-solving and continuous improvement efforts, and communications with the Facility Manager and Operations team.

Assist in the oversight of the metrology program at the site (i.e., equipment, personnel qualifications, validations, etc.).

Support the site QAS and Facility Manager in aseptic operations compliance (e.g., cleaning, sanitation, organization, etc.)

Support compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements.

Assists QAS, Directors, QA and Regional Managers, QA, etc. as necessary.

Three (3) years of professional experience within Technology or a related field

Two (2) years of professional experience in mobile applications quality assurance

Experience with XCode for iOS and/or Android Studio for Android

Experience with Charles Proxy or equivalent tool

Five (5) + years of professional experience within Technology or a related field

Knowledge of mobile app deploying to test app stores

Knowledge and experience with implementation, maintenance, and audit of Quality Management Systems (ISO 9001 or similar)

Excellent project management and organization skills

People: Accomplishes objectives through high quality recruiting, selecting, orienting, training, assigning, scheduling, and performance management of employees.

Quality risk identification and management

5+ years experience in manufacturing in chemical industry (surfactants and person care product manufacturing preferred)

5+ years of supervisory experience

Prior experience with document management and record-keeping.

Administer Electronic Document Management Systems with a focus on Quality.

Bachelor's degree or equivalent experience in a relevant field.

Strong organizational abilities and attention to detail.

Excellent written and verbal communication abilities.

Ideal candidates would be needing the following qualifications:

Strong project management skills including the ability to handle multiple projects concurrently

Ensure customer issues are addressed while maintaining compliance with internal company requirements and standards and agency or government regulations

Mentor less experienced colleagues and assist with their development

Provide guidance to team regarding documentation and resolution requirements

Strong analytical skills with high attention to detail and accuracy

Excellent verbal, written, and interpersonal communication skills

Minimum of 5 years in quality management and supervision or related education, training, management and supervisory experience.

Assist with a training program to continually reinforce and upgrade personnel qualifications related to Quality Management Program.

Know and understand Floworks Quality Management System requirements, Operating and Technical Procedures and workplace instructions.

Working knowledge of personal computers as related to management software uses.

Perform various other duties as required by management, within the physical constraints of the job.

Understand and comply with all Safety and Environmental requirements.

Assist in the advancement, implementation or enhancement of quality processes and procedures, such as change control, CAPA, and risk management.

Assist in leading the Management Review meetings.

Support cross-functional teams to support all aspects of quality management, including documentation, testing, audit, and continuous improvement.

Coordinate complaint management activities and Customer Feedback activities.

Strong knowledge and/or experience with ISO9001:2015 or higher ISO

Conduct internal audits and assess compliance with ISO9001 standard and customer requirements.

• 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.

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.

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

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

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

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.

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.