Sr Qa Specialist Investigations And Capas Jobs

Perform all job duties consistent with the 4-I values (Integrity, Intensity, Innovation, and Involvement).

Ability to influence and create an environment to encourage and promote adherence to Quality Assurance policies and requirements.

Minimum 8-10 years of industry experience in Quality Assurance and/or Quality Control with similar leadership experience.

The Sr. Manager, Quality Assurance position is the lead Quality

Serve as Quality member of Product Approval Committees for new product development projects to ensure high-quality product performance in the market.

Serve on PCA Operations Leadership team as Quality Representative and ensuring Quality is included in the Operations strategy.

Should possess strong interpersonal skills, solid communication skills; both written and oral.

Computer skills: - MS Word, MS Excel

Solid working experience with oscilloscopes, meters, and other instruments to capture data.

Medical, Dental, & Vision benefits - Effective Day 1

Understand and apply formal problem-solving tools.

This individual should be very comfortable engaging at all levels of the organization and shall be independent and a self initiator.

Supports the day-to-day management of the batch release process.

Communicates proactively with internal and external partners and management

Master’s degree with 3-5 years or Bachelor’s degree with 5+ years of relevant work experience

Experience providing QA support and oversight of GMP manufacturing operation

Experience with large molecule, biologics, cell/gene therapy, or Vial Vector/AV vectors

Experience successfully leading event investigations, Root Cause Analysis and CAPA

Must be able to discern the criticality of issues and to communicate to management regarding complex issues

Good written and verbal communication skills are required

Ability to summarize and present results, and experience with team-based collaborations is a must

Must exhibit strong leadership skills and effectively develop others

Ability to manage conflict and issues that arise with internal or external customers

Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs

Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity

QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones

Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.

Assist functional areas with achieving timely and compliant final product disposition of the product.

Review, approve and support procedures and production/testing records as required and assist in the training of site associates.

Review, approve and support investigations, corrective and preventive actions, change controls, and complaints, as required.

Strong experience in a test management tool, like ALM or Qtest or something similar

Experience leading the development of test automation solutions within a quality assurance team Additional Knowledge & Skills

Understanding the Macro Helix domain and learning how customers use Macro Helix products to manage their business

Experience leading a team of QA professionals

Experience testing large, complex, commercially available software solutions

Demonstrated experience utilizing test automation in functional, acceptance and integration testing

Should possess strong interpersonal skills, solid communication skills; both written and oral.

Computer skills: - MS Word, MS Excel

Solid working experience with oscilloscopes, meters, and other instruments to capture data.

Medical, Dental, & Vision benefits – Effective Day 1

Understand and apply formal problem-solving tools.

This individual should be very comfortable engaging at all levels of the organization and shall be independent and a self initiator.

Prior management experience in a medical device, pharmaceutical or heavily regulated industry.

Strong analytical skills including trend and statistical analysis, interpersonal, and management skills.

Responsible for performance management of assigned team members.

Present trends from investigation findings and recommendations for improvement to management.

Manage the timely analysis of data, development of investigation plans and execution of investigations to identify root cause(s).

Excellent problem solving and root cause analysis skills.

Ensure risk management procedures are utilized correctly

5+ years of experience in a quality role or a combination of education and experience

Ensure company compliance with GxP requirements, company policies and procedures, ISO standards, and MDD/MDR requirements

Ensure ongoing abidance by industry regulatory and quality requirements

Experience working in a quality capacity (pharmaceutical or medical device preferred)

Experience working in an ISO environment

Ensure risk management procedures are utilized correctly

5+ years of experience in a quality role or a combination of education and experience

Ensure company compliance with GxP requirements, company policies and procedures, ISO standards, and MDD/MDR requirements

Ensure ongoing abidance by industry regulatory and quality requirements

Experience working in a quality capacity (pharmaceutical or medical device preferred)

Experience working in an ISO environment

15+ years of experience in software development, DevOps, QA, or Operations management, or a related field.

Strong project management skills, with the ability to prioritize and manage multiple initiatives simultaneously.

Manage and monitor the release management process, including coordination with development and operations teams.

Communicate DevOps, QA, and Operations initiatives, progress, and results to executive management and stakeholders.

Develop and manage DevOps, QA, and Operations budgets, ensuring alignment with organizational goals and objectives.

Strong knowledge of DevOps principles, processes, and tools, including CI/CD, automation, and infrastructure as code.

Create detailed test cases for full system requirement coverage/traceability

Intermediate knowledge of QA standards

Increasing technical knowledge as it relates to O'Reilly's tech stack

· Previous experience with software testing

· Strong verbal and written communication skills

Work as the project lead on moderate sized software projects

Experience managing Document Control, NCRs, Audits, Management Review, CAPAs, Change Control, and Supplier Management processes

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

Manage and maintain the Document Control system, ensuring all documents are current, accurate, and compliant with requirements and policies

Oversee and manage the Management Review process, including the preparation of repots and presentations for senior management and other stakeholders

7+ years of experience in quality assurance, preferably in the medical device industry

Knowledge of FDA regulations and ISO standards related to medical devices

Strong project management skills with the ability to plan, organize, and multitask

Conducts investigations on atypical events and documents accordingly to meet a Code of Federal Regulations requirement

Investigation writing experience; production related experience in a highly regulated or cGMP environment.

Excellent presentation skills, meeting facilitation skills, verbal and written communication skills with all levels of the organization

Regular and predictable onsite attendance and punctuality.

Interviews the people involved with the process in question

Assist with trend analysis and report the analysis to management as appropriate and monthly KPI tracking for complaints.

NOTE: Relevant BIAH experience may be weighted more significantly.

Work experience in USDA or European Union (EU) regulated animal health industry required.

Good written and communication skills, strong investigative skills required as the position involves investigation involving various products and various departments.

Requires knowledge of vaccine products, manufacturing procedure and processes.

Has sound decision making skills along with ability to take quick actions and excellent attention to detail.

Bachelor’s degree in Human Resources or a combination of education, training, and relevant experience

Advises and assists managers and other internal stakeholders on EEO related matters.

Educates managers and employees, through one on one interactions and formal trainings, on prevention of workplace harassment.

3 years of relevant experience, including working in EEO, Law, Employee Relations, and/or Human Resources

Excellent written and verbal communication skills

Customer service focus and strong interpersonal skills

Reports to the Manager, Trade Compliance Strategic Applications in the Communications Systems segment of L3Harris Technologies, Inc.

Lead and guide internal investigations related to potential regulatory violations

Oversee the completion of corrective actions, to include tracking, validating, reporting on, and closing corrective actions

Draft government disclosures, notifications, closure justifications, and extension requests, and compile enclosures for submission

Track, update, and report on the status of all investigations, disclosures, and closure justifications

Maintain and contribute to CS Trade Compliance’s internal information web portal, file repositories, collaboration sites, and Trade software tools

Oversee the management of cGMP training files in the electronic document management system

Business administrator for electronic documentation management systems (Veeva QualityDocs EDMS) and Learning Management System (SuccessFactors LMS)

Identify trends, monitors document control and records performance and metrics, and participates in quality management review (QMR).

Heres What Youll Need (Minimum Qualifications)

Bachelors Degree in Chemistry, Biology or a related scientific discipline, or equivalent work experience

Heres What Youll Bring to the Table (Preferred Qualifications)

Requires 3-5 years’ experience in Banking Services, branch operations, risk management or related function and two years’ of BSA/AML experience

Bachelor's Degree or equivalent experience

2 years’ experience using Microsoft Office

Good knowledge of Bank Secrecy Act and USA PATRIOT acts

Great communication and writing skills.

To be considered for this position you must meet at least these basic qualifications

10+ years of hands-on experience in handling software QA responsibilities at enterprise level.

Manage day to day automation, performance and end to end QA and validation duties to support R+F applications and associated systems

Hands on experience and proficiency in qtest, TOSCA, JMeter and other testing tools

Experience with test Automation frameworks such as Selenium and Cucumber

Working knowledge of Jira, Jenkins, bitbucket, Splunk

Experience with testing on mobile devices and browsers