External Quality Associate Jobs

Knowledge of Basic Archive Research & Media Management

Develop knowledge of all resources available for research purposes

Experience necessary with Premiere Pro

Develop knowledge of NFL file-based delivery systems such as Signiant Media Exchange

Thorough knowledge of NFL & its history required

Non-linear editing & research experience

• Knowledge, Skill and Abilities

• Good project management skills

• Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

• Must have basic English written and oral communication skills adequate to communicate with other team members.

• Minimum of 5-8 years of experience in Quality, or related field in the medical products industry.

Job Title: Quality Associate III

Pay: $110-115/ Hourly based on experience

• Ability to manage internal DSCSA deviation investigations through resolution and approval.

• Requires business and application experience in warehouse operations including managing orders, inventory, warehousing, and logistics.

• Well versed in general IT capabilities.

• Proven ability to function in a self-directed environment, can manage multiple projects simultaneously

10+ years of related experience

Demonstrated excellence in the education and development of small-group leaders.

Strong listening and communication skills.

wide variety of people with a range of knowledge base.

requirements set by the Presbyterian Church (U.S.A.). In addition, the ideal candidate will have a vision for

Develop and strengthen the church's small-group ministry program by recruiting, training, and

Provide support and outreach to young adults and young families within the congregation, and develop

Performs daily tasks including data entry, track returned finished goods movement through the facility, and assist others in understanding quality issues.

Understanding and working knowledge of quality tools and problem solving methodology.

Computer skills required including Office (Word, Excel).

Inspects a selection of finished product (QA) against customer expectations and NB Global Standards.

High school diploma or equivalent and 5 plus years in a manufacturing and/or a quality assurance environment. Associate degree preferred.

Ability to recognize and problem solve root cause(s) of defective product.

Lead project manager for all External Affairs projects and able to offer support when necessary.

Reconcile and manage corporate credit card and expense reports for the Vice President and other finance related duties.

Manage written and oral communication with various stakeholders including members, partners, and clients.

Manage ABFE job board which includes correspondence with ABFE members and other stakeholders.

Excellent writing and verbal communication skills

Results-oriented with proven ability to manage multiple projects.

Collect and publish quality and compliance metrics and reports trends to management

Track and oversee document management to assure quality compliance

Coordinate / revise / manage QA SOPs and product specifications

Document and coordinate product risk assessments to assure compliance with Quality System requirements

Strong analytical, organizational and problem solving skills

Excellent written and verbal communication skills

5 years management/supervisory experience in cGMP organization.

Experience working with CMOs, CTLs, vendors, and relationship management preferred

Working knowledge of relevant US and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participation of regulatory inspections.

Bachelor’s degree in relevant scientific discipline with minimum experience of 10 years within quality control.

Experienced in executing quality control testing, analytical method transfers and validation within a biotechnology industry.

Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.

Provide detailed analysis and reporting on the financials to desk heads, business managers, and senior finance management

Required Qualifications, Capabilities And Skills

Experience doing P&L and month end close process

Bachelor's degree in Accounting, Finance, Business or related area

Strong analytical skills and attention to detail including a strong control focus

Excellent communication skills and ability to develop strong working relationships.

Able to identify, escalate, and communicate issues to management in an effective and succinct manner

A hybrid working model, allowing for in-office / work from home flexibility, generous vacation, personal and volunteer days

Competitive compensation packages including health and wellbeing benefits, retirement savings plans, parental leave, and family building benefits

Educational resources, matching gift, and volunteer programs

Relevant experience of AML Investigations and Correspondent Banking investigations experience

Experience in Correspondent Banking investigations

Education And Qualifications / Skills And Competencies

Conduct tests manually or automatically during the development/testing/optimizing phases of SAP IAG software offering.

Actual working experience with software development and operation lifecycle is essential.

Must have good communication skills in both verbal and written proficiency. Multi-linguistic is very helpful but not mandatory.

Has basic to advanced working experience with Microsoft Office products, such as Word, Excel, or PowerPoint.

Basic working knowledge of modern software automation testing tool is important.

Prior experience with drug substance and drug product manufacturing, including aseptic operations and with managing external manufacturing operations.

Upstream, downstream, fill finish and plasmid manufacturing experience preferred. A subset of this experience can be considered.

A continuous improvement mindset, with prior experience managing performance objectives, monitoring and assessing results, identifying areas for improvement, and implementing solutions.

Demonstrated project leadership skills with the ability to provide cross functional, and cross-company leadership of key initiatives.

Prior hands-on GMP operations experience, prior experience preparing for and executing manufacturing site regulatory inspections and regulatory filings.

Prior experience managing manufacturing of gene therapy products is strongly preferred.

Previous experience driving a forklift is preferred

Previous inspection experience is preferred

Previous manufacturing or warehouse experience preferred

Physical Requirements / Working Conditions:

Benefits that set Toyota apart:

Ability to read Inspection Standards to insure the quality of the product being inspected.

Update trackers and required applications & tools and keep management informed of emerging issues/risks

Works closely with Quality Team Lead and Manager to aggregate, prioritize, and report on the top issues impacting the program

Be an exceptional team player when it comes to knowledge sharing, training, people development and reporting

Participate in special projects/manage individual projects, and act as a guide to ensure the project meets SLA’s

Strives to identify new opportunities to provide a better reviewer and end-user experience

Contribute to and participate proactively in knowledge sharing sessions

Scan records as per the provided list by the manager.

Demonstrate strong attention to detail and quick learning abilities.

Significant experience in scanning quality documents in a GMP environment.

Fresh graduates with experience using commercial scanners and editing documents with Adobe will also be considered.

Scan records ranging from 50 to 500 pages.

Support various teams within Abbott's molecular diagnostics site.

Familiarity with buy-side investment management workflows

2+ years of work experience in the financial services industry

Strong interest in FinTech, with prior knowledge of databases

Experience advising Clients on portfolio strategies, portfolio optimization, risk assessments, and attribution

Outstanding communication and presentation skills, with the ability to convey complex concepts simply and clearly to clients

Experience with SQL, UNIX, modern programming languages, and/or Aladdin

Assist with reviewing and communicating ImPaQ (Quality Management System) cases

2 years of relevant experience in Quality

Strong analytical, quantitative, and interpersonal skills

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Be an advocate for Quality, driving a strong and committed Quality culture throughout the organization

Assist with Historical Quality Data Processing and Reporting to help define trends/focus areas

Documenting and reporting compliance issues to management

Partnering with other Quality colleagues on significant product quality impact assessments, particularly for notifications to management, recalls, etc.

Risk assessment and risk management

Excellent written and verbal communication and negotiating skills

Strong mature leadership and interpersonal influencing skills

Minimum 5-8 years’ experience of drug substance/drug product manufacturing processes in a cGMP environment and technology transfers.

A. Education / Training and Work Experience

Beaumont offers a comprehensive benefits package to meet your financial, health and life-work balance goals.

Knowledge of Formal PI methodology

Knowledge of Kaizen and Kaizen training activities

For Bachelor’s degree candidates: 3 – 5 years’ experience in clinical data abstraction, patient safety activities, and/or clinical quality improvements required

Certification in patient safety/process improvement preferred.

Prepare on a Monthly basis the Quality Data Review and Management review presentations of the Operations area.

Take decision, problem solving, time management, negotiations, personnel interview, feedback and recognition.

EDUCACIÓN Y/O EXPERIENCIA (EDUCATION AND/OR EXPERIENCE):

TAREAS Y RESPONSABILIDADES (DUTIES AND RESPONSABILITIES):

Participate and maintain full knowledge of the operations

Keep in compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies.