Quality Assurance Senior Associate Jobs

• 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.

• 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

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.

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

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.

Expert working knowledge of regulatory requirements, standards and regulations, with experience of managing inspections/audits by the FDA and other bodies.

Masters degree in Business Management or MBA is preferred

Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.

Corporate and GQO requirements, Quality System Regulations and standards.

Minimum of 6+ years' experience in a Medical Device, Pharmaceutical, Bio-Medical/Pharma, or regulated manufacturing environment.

Experience of successfully creating and managing a talented, engaged and performing team is advantageous.

Partner with Training and Management to identify programs that reduce errors, and improve both individual and department results.

Work in conjunction with the Call Center Management team to improve the overall associate and department QA scores.

Maintain positive, productive, and effective relationships with peers, management, and call center employees.

What other skills/experience would be helpful to have?

Provide statistical data and patterns of top errors by client, product/benefit, and department/team.

Ability to work with various skill sets, personalities, and working styles.

Experience with Agile/Scrum methodology and JIRA, test management tools such as QMetry.

Tuition reimbursement and education benefits

Bachelor's degree in Computer Science or Information Technology; or equivalent years of experience

At least 5 years of hands-on experience in software quality assurance with at least 2 years as a Team Lead

Hands-on experience with manual and automation testing on android applications, microservices, APIs, AWS

Experience with automated script development using Python, JavaScript, Appium, selenium, and maven is preferred.

Must possess organizational skills with the ability to use resource materials to manage multiple projects

Reviews customer purchase orders, specification and prints to ensure processing meets all requirements

Experience in diffusion coatings operations and processes/equipment typically used in a coatings-manufacturing environment

Proven ability to combine theoretical training with practical experience in a "hands-on" environment

Excellent written and verbal communication skills

Experience with ISO/AS quality systems

Excellent writing skills and the ability to succinctly convey information to senior business and compliance management.

Keeping management apprised and recognizing when to escalate issues as needed.

At least 3 – 5 years of BSA/AML banking compliance or regulatory experience.

Experience working with FFIEC Exam Manual high risk customer types, including conducting CIP, KYC, and CDD / EDD.

Experience with transaction monitoring and case investigations, including Suspicious Activity Report filing.

CAMS and/or ACFCS certification desired.

Expertise in Microsoft Access and Excel, with Adobe InDesign or Quark Express experience preferred.

Prior B2B / B2C eCommerce experience a plus.

Tuition Assistance Program that covers professional continuing education.

Develop and implement quality assurance / testing policies, processes and procedures.

Conduct manual testing of website defects and new enhancements.

Perform regression testing of site functionality as part of an SDLC.

Strong knowledge of risk-based approach to commissioning, qualification and validation activities in a biotech manufacturing environment.

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

Experience reviewing and approving commissioning and qualification documentation

Provide QA oversight for the qualification of laboratory equipment and systems.

Provide QA oversight for the qualification, validation, and transfer of analytical methods.

Strong computer skills including MS Office (Word, Excel)