Associate Quality Assurance Manager Jobs

• 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

Support the execution and implementation of a Corporate Quality Management System (QMS) software.

5+ years of Quality Assurance experience in Pharmaceuticals, Compounding and Warehouse activities.

Quality Assurance certifications are a plus.

Excellent cross-functional collaboration, communication, and interpersonal skills.

Utilize the Quality GAP analysis to implement short and long-term Quality goals and objectives.

Determine, develop and train employees on appropriate inspection points at the warehouse using AQL inspection method techniques.

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

Experience with a Learning Management System, such as Plateau or SAP SuccessFactors Learning highly preferred

Update GMP training materials, as needed, to reflect current practices, regulatory requirements, and industry trends

Identify and implement process improvements to guarantee training effectiveness and personnel qualification

Bachelor’s Degree in Life Science or Education

2-3 years’ experience working relevant work experience in the Biotechnology or Pharmaceutical industries or relevant comparable background

Able to demonstrate strong internal customer service and interpersonal 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

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.

Strong experience in Quality Systems: CAPA, deviation, risk analysis and change control management.

Organizational Skills – Ability to balance multiple responsibilities and still meet high quality and timeliness standards under pressure.

Manage GCP inspection-readiness preparation for corporate Blueprint as well as CROs and investigator sites.

8 + years of demonstrated experience in Sponsor companies, CROs, GLP laboratories and/or GCP consulting.

Experience supporting Regulatory Authority GCP/GLP Inspections.

Relevant professional certifications are a plus.

Have demonstrated project management skills and management of complex cross-functional activities

Assist in the development, management, and implementation of strategies and initiatives, policies and procedures to support the PV audit program

Be responsible for primary internal customer base including Global Safety, LOCs, Safety Governance, Risk Management, QPPVs, GRA

Expert knowledge of global, regional and national PV regulatory requirements and regulations

Maintain an up-to-date and in-depth knowledge of appropriate national and international PV/GCP legislation and guidelines that affect the business

Maintain an in-depth knowledge of PV processes and procedures

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

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.

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.

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

3 years of experience in management of QA organization including management of third parties that are also delivering QA services.

Ensure that management and allocation of QA resources based on project needs is performed.

Develop and/or lead change management efforts across all phases of projects and initiatives to drive the Firm's culture of continuous improvement.

Establish relationship and governance with internal and third-party team members to conduct Quality Assurance responsibilities.

Oversee and manage a global QA team with diverse backgrounds supporting QA development, which may include one or more third-party organizations.

Bachelor's degree in Computer Science, Computer Engineering, Information Technology or equivalent experience.

Supports the maintenance and upkeep of the Quality Management System (QMS).

Manages the review cycle of QA controlled documents to assure practices reflect written procedures.

Knowledge of current GCP regulations preferred.

Maintains the Quality Assurance (QA) training program, document control, customer complaint program and CAPA program.

Supports clinical sites and vendors/suppliers.

Supports internal audit program and performance metrics system for continual improvement.

Updates, maintains and improves quality management systems process documents and documentation

Supports during regulatory inspections, audits and Management Reviews

Tracks, reviews and assists in organizing reporting metrics and data for use in continuous improvement and Quality Management System reviews.

A minimum of 3 years of relevant work experience in a GMP environment.

Health Benefits: Medical, Dental, Vision

a minimum of 3 years of relevant work experience in a GMP environment.

Support the execution and implementation of a Corporate Quality Management System (QMS) software.

5+ years of Quality Assurance experience in Pharmaceuticals, Compounding and Warehouse activities.

Quality Assurance certifications are a plus.

Excellent cross-functional collaboration, communication, and interpersonal skills.

Utilize the Quality GAP analysis to implement short and long-term Quality goals and objectives.

Determine, develop and train employees on appropriate inspection points at the warehouse using AQL inspection method techniques.