Quality Assurance Senior Specialist Jobs

Preferred Education, Experience, & Skills

2 to 5 years of experience in software testing, with a focus on automated testing.

Strong knowledge of automated testing frameworks and tools, such as PyTest, Selenium, or similar.

Familiarity with agile development methodologies and experience working in an agile team.

Experience collaborating with cross-functional teams to understand user stories and acceptance criteria.

Knowledge of 508 compliance testing and accessibility standards.

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

The only company to be recognized by KLAS twice for Overall Healthcare Management Consulting

Ranked #1 on Charlotte’s Healthiest Employers list for 2019, 2020 and 2022, and 49th Healthiest Employer in America (2022)

Named one of the World’s Most Ethical Companies® by Ethisphere® Institute for the 13th year in a row

You have experience writing detail-oriented test plans and test cases for manual testing.

Act as the day-to-day QA Owner for dedicated client projects, exhibiting senior-level ownership over QA planning and execution.

Read more about What to Expect through our Recruiting process.

Must have knowledge and experience with cGMP manufacturing, quality, and compliance as well as US and global cGMP requirements.

Excellent verbal and written communication skills with ability to prepare written communications and communicate problems to management with clarity and accuracy.

REQUIRED COMPETENCIES Knowledge, Skills, And Abilities

Able to recognize conflict and escalate to management.

Demonstrates a high degree of attention to detail, with strong documentation expertise. Able to effectively multi-task and demonstrate strong organizational skills.

Working knowledge of applicable business systems including SAP, LIMS/Celabs, Maximo and/or Veeva Vault.

Must have knowledge and experience with cGMP manufacturing, quality, and compliance as well as US and global cGMP requirements.

Excellent verbal and written communication skills with ability to prepare written communications and communicate problems to management with clarity and accuracy.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

Able to recognize conflict and escalate to management.

Demonstrates a high degree of attention to detail, with strong documentation expertise. Able to effectively multi-task and demonstrate strong organizational skills.

Working knowledge of applicable business systems including SAP, LIMS/Celabs, Maximo and/or Veeva Vault.

BS with 10+ years relevant Quality experience

Strong relevant experience in executing, developing, and/or administrating GMP programs in cGMP biotech and/or pharmaceutical environments.

What Takeda can offer you:

Responsible for review of all criteria required for disposition of raw materials and products

Responsible for review of investigations and quality systems related to disposition of specific batches

Responsible for SAP transactions relevant to disposition

Qualify and maintain skills as a green coffee cupper through the completion of knowledge check requirements and cupping skill maintenance objectives

Responsible for Quality Assurance daily management systems results and equipment maintenance, and calibration

Proven project management and time management

Additional skills and experience that we think would make someone successful in this role:

5+ years Quality Lab experience

Strong communication and cross collaboration skills

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.

Working knowledge and technical understanding of the manufacturing and testing of biologics or Cell and Gene therapy highly desired.

Paper batch records (drug substance or drug product) review and batch disposition experience is a plus.

EnsuresthatManufacturing F acilities andEquipment arecompliant withcGMP requirements:

Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:

Performs line clearances for all manufacturing runs in the Cleanroom. Must be willing to gown.

Verifies Leukopak Receipt. QA primary contact for verification of release of starting material performed by Supply and Logistics for GMP production

Good Knowledge of quality management systems

Strong knowledge in Quality Management Systems

Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave

Ensure that the current NN procedures & requirements from health authorities are reflected in the validation planning & quality related decisions

Minimum of five (5) years of experience within the pharmaceutical industry

Good Knowledge of cGMP manufacturing & production processes & how to apply

Project management experience although not required is beneficial to this position.

Ability to communicate information to customers and senior management.

Ability to effectively present information to top management, and public groups.

Knowledge of cGMP, cGLP and FDA regulations, as well as internal quality-related procedures.

Practical and theoretical knowledge of the basic principle of validation and its applications.

Excellent verbal, presentation, and written communication skills.

Excellent communication, analytical and time management skills. Must demonstrate ability and desire to continually learn.

Experience with test case management tools such as Azure DevOps, test case generation techniques, and problem tracking/reporting systems.

Experience with database management systems/SQL.

Experience developing UI and API automated tests

Experience testing web services that support protocols such as SOAP, REST and HTTP

Extensive experience with the creation/refinement of acceptance criteria

Excellent Communication, Time Management, Reporting and Analytical Skills

Use coding standard for automation testing, documentation, release and configuration management and expertise in CI/CD.

Exceptionally Strong SQL writing skills for Database Testing to ensure data integrity, validating database consistency and verifying accurate transaction

Provide Source to Target data validation for ETL, tables and feed files as per business requirements

Experience testing applications in cloud native platforms

Participate in scope definition, requirements analysis, functional and technical design, application build, product configuration, unit testing, and production deployment.

Strong time management and detail-oriented skills.

Strong leadership and management skills, with the ability to lead and motivate a team to achieve objectives

Conduct regular audits to assess the quality of our grant management processes, including application, reporting, compliance, and final grant reporting

Work closely with consultants to understand and mitigate the risks involved in grant management

Maintain/pursue ongoing knowledge, certifications, training, and subject matter expertise as appropriate

10+ years' advanced or subject matter expert level knowledge/experience working in a leadership role

Knowledge of Software Quality Assurance or Software Engineering Methodologies.

Reviewing and interpreting business requirements and design specifications and translating them into test procedures.

Good communication skills (interpersonal, listening, written and oral), be self-motivated, organized, thorough, and efficient.

Skill with application testing using SQL, PL SQL.

Skill with testing of applications designed in Java, and .NET.

Skill with developing Web application testing automation using Java and Selenium, or similar.

Perform electronic archival of Category 1 and Category 2 packets and upload to server or document management system

Working knowledge of GMP, Quality Systems, and regulatory requirements (21 CRF Part 11/210/211/600/610), practices/principles

Master's Degree and 2+ years' experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations OR

Bachelor's Degree and 4+ years' experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations OR

High School Degree and 8+ years' experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations

Knowledge of relevant ICH and FDA guidance documents

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.

Mastery knowledge and expert experience with system development, data analysis, analytic application, reporting, administrative data sources, data use policies and procedures.

Mastery skills in analyzing healthcare service requirements and formulating policies. Ability to plan, organize, and implement independent projects concurrently.

Mastery knowledge of Quality Framework for long-term care programs.

Works with healthcare provider organizations and healthcare advocacy organizations on policy and programmatic changes.

Provides training and support to the Quality Improvement Strategy team on systems, policies, and procedures.

to support a local contract.

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