Global Senior Quality Assurance Specialist Jobs

4-6 years of experience in the finance industry focusing on quality assurance for AML transaction monitoring, internal/external investigations, and KYC functions

Conduct quality assurance reviews on transaction monitoring and customer due diligence

Analyze completed cases to ensure that analysis is completed and all required and relevant documentation supporting each review is provided

Review cases related to the disposition of adverse media alerts to ascertain whether they are correctly determined

Collaborate with the AML Team to provide feedback as appropriate and ensure any corrective actions required are completed

Participate in the development and implementation of procedures and objectives for the QA function

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

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.

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

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

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

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

Oversees and leads quality and compliance risk management initiatives to minimize risk and potential impact of quality and/or non-compliance events

Provide leadership in global issue management (GIM) including product complaints and product recall process management and reporting.

Extensive knowledge and experience in GMP, GCP and GDP global regulations, principles, concepts, practices, and standards.

Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management

Develop and manage department budgets and long-range plans for the team.

15+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry

Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs)

Proactively report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented and documented.

Report and escalate compliance issues to management, including requests for directed audits and manage Quality Council Quarterly Meetings.

Lead, develop and manage R&D quality systems (procedures and processes) to provide compliance oversight, training and inspection readiness.

Train on QA overall, R&D SOPs, QA related regulatory intelligence and requirements, inspection readiness.

Manage QA reviews of project-related essential documents.

Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control requirements.

Completes software quality tasks in accordance with current Quality System Requirements.

Works independently with objectives given by SWQA Manager.

Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.

5 to 8 years’ experience in Software Quality Assurance and/or Software Testing experience.

Must have excellent oral and written communication skills.

Familiarity with basic business process management activities (process mapping, improvement, implementation, etc.)

Maintain comprehensive knowledge of payroll tax changes and rules; utilize all available data and resources to make and support complex decisions

Support other teams, including Customer Success and Finance as a payroll subject matter expert

Demonstrable working knowledge of annual wage bases, employee and employer taxes, and accrual rules

Execute day-to-day operations for Justworks’ payroll system, such as processing and reviewing customer payroll and handling corrections

Monitor payments processing, triage and resolve incoming payroll related issues

Drafting and revising controlled documents such as policies, processes, and procedures associated with the Quality Management System (QMS).

Knowledge of FDA/EMA/ICH regulations and guidelines regarding compliance requirements

Experience working with electronic system(s) to ensure compliance in 21CFR Part 11 and other applicable regulations.

Excellent written and verbal communication skills with the ability to communicate cross-functionally.

Innovation and strategic compliance skills including identification and implementation of best practices.

Prior experience working in compliance for cell or gene therapy manufacturing.

Strong analytical and problem solving skills, including understanding of risk management and risk-based quality systems

8+ years experience in leading or managing quality systems in regulated and non-regulated spaces. (ie, ASQ certification, past experience),

Bachelor's degree (or equivalent experience)

10 years of professional experience in areas of Supply Chain/Manufacturing Operations, Quality Improvement, or Continuous Improvement/Optimization work.

Strong leadership & Influence skills – Ability to set direction and drive results

Strong coaching and development skills

Knowledge of learning management systems and web delivery tools

Detail oriented team player with effective time management, planning, organization, and execution skills.

Minimum of an Associates degree and/or equivalent combination of education and experience is required.

Experience working with Subject Matter Experts and translating content and performance requirements into sound training content.

5-8 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals, cell therapy manufacturing, or quality control is preferred.

Knowledge of adult learning methods, strategies, and techniques.

Recommends improvements to record management systems and/or work order processes to ensure the integrity of company records.

Communicates the information to company personnel at all levels, including making presentations to management teams.

Leads team initiatives, through frequent communication with the team and management.

Benefits eligibility begins on your first day

ASQ Certified Auditor or Lean Six Sigma Green Belt Certification.

Subsides metro and parking discounts

Strong database management, including development, maintenance, and evaluation (metrics).

Assist in the scheduling, performance, and tracking of Kite Audits in accordance with regulatory and company requirements.

Execute audits to verify compliance with global Good Manufacturing Practices regulations, product CMC license/dossier filings, and corporate requirements.

Assure communication of compliance concerns, regulatory agency expectations and industry trends as part of on-going education and training for GMP compliance.

MS/MA Degree in life sciences or engineering discipline and 6 years of experience in regulated industry, biologics or biotech.

BS/BA Degree in life sciences or engineering discipline and 8 years of experience in regulated industry, biologics or biotech.

Provide additional support for certification programs.

Education: Bachelor’s degree in Food Science, Microbiology or related fields.

Experience: Minimum 4 year of responsibility in food and/or supplement quality role.

Knowledge of cGMP, regulatory affairs, business processes (stage gates), consumer complaints, GMP warehouse standards, and quality documentation.

Excellent communication skills, both written and oral.

Experience with NetSuite a plus.