Top 49 Senior quality specialist Jobs in Gainesville, Fl

Senior Quality Specialist, Quality Operations
Ascend Advanced Therapies FL, Inc. —Alachua, FL
- Full-time
- 5 years
- Bachelor of Science
- Mentoring
- Health savings account
- Health insurance
Quick Apply
Test Engineer - Fluids | New Glenn (Mid to Senior | D and 3rd Shift)
Blue Origin —Florida
- Background check
- Management
- Schematics
- Paid parental leave
- Paid holidays
Senior Human Resources Business Partner in Gainesville, FL
The Collier Companies —Gainesville, FL
- Full-time
- Background check
- 5 years
- English
- Health insurance
- Dental insurance
Quick Apply
7d
Cath Lab Tech Lead
HCA Florida North Florida Hospital —Gainesville, FL
- Full-time
- Mid-level
- Trade school
- Medical-Surgical
- Employee stock purchase plan
- Disability insurance
Quick Apply
Senior Cyber Security Specialist, Technology and Digital, FT,8:30A - 5P
Baptist Health South Florida —Florida
- $99,583.81 - $129,458.95 a year
- Full-time
- Bachelor's degree
- Mentoring
- Senior level
- Wellness program
- Health insurance
2h
Patient Representative
AVECINA - Butler Plaza —Gainesville, FL
- Full-time
- Internal Medicine
- Urgent Care
- Entry level
- Employee stock purchase plan
- Disability insurance
Quick Apply
Senior Public Relations Specialist
University of Florida —Gainesville, FL
- $61,000 - $65,000 a year
- Weekends as needed
- Master's degree
- University
- Bachelor's degree
5d
Medical Record Technician (Coder-Outpatient and Inpatient)
US Veterans Health Administration —Gainesville, FL
- $60,885 - $79,147 a year
- Online Application
- Background check
- Anatomy knowledge
- Microsoft Outlook
- Paid parental leave
- Paid holidays
2d
Researcher III
Cherokee Federal —Gainesville, FL
- $54,000 a year
- Full-time
- Background check
- CPR Certification
- 5 years
- Health insurance
- Dental insurance
Quick Apply
FOOD CONTROL SPECIALIST - TRAY LINE - 67013476
The State of Florida —Gainesville, FL
- $34,760 - $38,236 a year
- Online Application
- Background check
- Writing skills
- Assembly
- Paid holidays
- Health insurance
13d
CCP Operations & Monitoring Specialist
ECS4KIDS —Gainesville, FL
- $26.61 an hour
- Full-time
- Background check
- Classroom
- Writing skills
- 403(b) matching
- Paid holidays
Quick Apply
AR Resolution Specialist Lead
The Cardiac and Vascular Institute —Gainesville, FL
- Full-time
- Hybrid work
- Research
- High school diploma or GED
- Analysis skills
Quick Apply
Training Specialist
The Chemours Company —Starke, FL
- $73,947 - $115,542 a year
- Full-time
- Military
- Mid-level
- 3 years
- Commuter assistance
- Employee stock purchase plan
Home Health Coder II
HCA Florida North Florida Hospital —Gainesville, FL
- Full-time
- Mid-level
- Home Health
- 1 year
- Employee stock purchase plan
- Disability insurance
Quick Apply
11d
Clinical Research Coordinator I - Neuromuscular Division
University of Florida —Gainesville, FL
- $46,000 - $52,000 a year
- Full-time
- Customer service
- Writing skills
- Clinic
7d
Senior Biologist
Barge Design Solutions —Gainesville, FL
- 5 years
- Bachelor's degree
- Quality control
Move Specialist - Packing, Unpacking, Sorting (Part-time)
Family Nest North Central Florida —Gainesville, FL
- $16 an hour
- Part-time
- Heavy lifting
- Travel
- In-person
- Opportunities for advancement
- Flexible schedule
Quick Apply
9d
Senior Casualty Claims Specialist, Attorney Represented - Southeast
Liberty Mutual —Gainesville, FL
- $61,000 - $126,000 a year
- Full-time
- Mid-level
- Bachelor's degree
- Experience equivalent to degree accepted
Licensed Practical Nurse - LPN
HCA Florida Gainesville Primary Care —Gainesville, FL
- Full-time
- Primary Care
- No experience needed
- Mid-level
- Employee stock purchase plan
- Disability insurance
Quick Apply
12d
Medical Assistant
Heart & Lung Surgery Specialists —Gainesville, FL
- Full-time
- Surgery
- No experience needed
- 1 year
- Employee stock purchase plan
- Disability insurance
Quick Apply

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Senior Quality Specialist, Quality Operations

Ascend Advanced Therapies FL, Inc.
Alachua, FL

Quick Apply

Job Details

Full-time

Benefits

Health savings account
Health insurance
Dental insurance
401(k)
Flexible spending account
Paid time off
Parental leave
Employee assistance program
Vision insurance
401(k) matching
Life insurance

Qualifications

Drug regulation
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

Job Overview

Ascend Advanced Therapies is seeking a Senior Quality Specialist, Quality Operations to provide end-to-end Quality Assurance support for the manufacture and release of gene therapies, oncolytics, vaccines, immunotherapies, and other biological products in a GMP-regulated environment. This role partners closely with Manufacturing, Quality Control, and cross-functional teams to ensure compliance with FDA, EU, and ICH regulatory requirements while supporting product disposition, batch record review, investigations, CAPAs, change controls, audits, and continuous improvement initiatives.

The ideal candidate brings strong GMP Quality experience within biologics, cell therapy, or gene therapy manufacturing and possesses the ability to apply regulatory requirements to complex operational situations while promoting a culture of quality throughout the organization.

Duties

Provide end-to-end Quality support for the manufacture of mid-phase through Commercial gene therapies, oncolytics, vaccines, immunotherapies, or other biological products under the regulatory purview of current Good Manufacturing Practices (21 CFR Parts 210/211, 600, and 610); to include, but not limited to, the following:

o Review and approve master batch records, material specifications, quality control test methods/validations, raw material inspection and release packets, environmental monitoring data, and any other documentation associated with the development, execution, and review/approval of manufactures for product release.

o QA on the Floor

o Room Release activities

o Drafts and/or approves Certificates of Analysis, Certificate of Compliance, and any other certificates issued to Clients in support of product disposition and release.

o Acts as QA representative in Client meetings; providing sound Quality perspectives, citing the appropriate regulations, standards, or guidance to resolve potential issues.

o Acceptance Quality Limit (AQL) inspections

o QA on the Floor

o Room Release activities

o Drafts and/or approves Certificates of Analysis, Certificate of Compliance, and any other certificates issued to Clients in support of product disposition and release.

o Acts as QA representative in Client meetings; providing sound Quality perspectives, citing the appropriate regulations, standards, or guidance to resolve potential issues.

o Acceptance Quality Limit (AQL) inspections

Write, review, and revise Standard Operating Procedures (SOPs)
Provide QA oversight to ensure adherence to procedures, while also increasing compliance awareness and promoting a culture of quality throughout the company through strong collaborations with the cross-functional teams.
Readily identify gaps in compliance during conversations and can devise an equitable solution that resolves the issue(s) and ensures regulatory compliance.
Provide training in GxP regulations, best practices, and internal requirements
Provide direct support in investigating complex issues and non-conformances – is able to use critical thinking to establish investigation plans and effective, data-driven discussions in evidence of root causes.
Be proactive in forecasting upcoming tasks and is highly communicative with Management and other departments in establishing business priorities.
Establish and implement effective CAPA and Change Control plans
Performs internal and external (i.e. supplier/sub-contractor) audits.
Assist with the analysis of trends and metrics to recommend and implement continuous quality improvements.
Interface with contract testing organizations and alliance partners to resolve quality-related issues with minimal supervision
Host Client audits and/or regulatory inspections.
Other duties as assigned.

Qualifications & Education Requirements

Minimum of BS in Life Science or equivalent years of education and/or years of experience (i.e. Associate's Degree and minimum 5 years in a regulated pharmaceutical environment)
A minimum of 5-7 years’ experience in a technical or administrative field related to the industry or equivalent in a GMP (biologics) environment is required.
5+ years of experience in biologics, cell therapy or gene therapy manufacturing Quality.

Preferred Qualifications

Strong foundational knowledge of US FDA cGMP regulations is required, and some experience with EU GMPs (Directives 2001/83/EC and 2003/94/EC) and ICH guidelines is highly preferred. Must possess the capacity for applying regulatory knowledge to practical situations throughout the organization.
Understands the distinct difference to achieve and sustain manufacture of Commercial Products in the regulatory space, not just early phase clinical materials.
Experience with GMP manufacture of biological products; technical aptitude needed for reviewing master batch records for production or testing and can readily identify process gaps.
Critical thinking and resourcefulness to help solve complex issues that involve various cross-functional teams.
Strong communication skills, both with internal and external parties. Awareness of when to escalate matters to Management.
Can handle difficult conversations with professionalism and objectivity.
Shows initiative in seeking out work and not waiting for instruction. Understanding the objectives of the Quality team are shared, and success is dependent on partnerships and the willing support of the entire unit.
Ability to work independently and possesses the knowledge and credentials to represent the Quality unit objectives without constant Management oversight.
Capable of making decisions or can provide input to Management for reaching resolutions.
Possesses a willingness to share knowledge, even mentoring more junior members, where possible.
Highly meticulous and detail-oriented in reviews; is able to sort through many data sets to assemble a full picture with the understanding of its outputs and impact.

Physical Requirements

Physical demands: (check one)

sedentary (< 10 lbs.) x light work (< 20 lbs.)

Physical activity:

walking
typing/grasping
standing
hearing
Visual acuity (preparing/analyzing data, transcribing, reading, use of measuring devices, machinery labels, color differentiation, etc.)
Personnel may be required to be vaccinated in order to perform some job duties.
Working conditions (indoor/outdoor, noise levels, hazards, working quarters)

Travel Requirements

Less than 10%

Supervisory Responsibilities

This position does not require previous supervisory experience.

Location

This position is onsite in Alachua, FL (Gainesville, FL metropolitan area)

Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Retirement plan
Vision insurance

Quick Apply

Refine Your Search

senior quality specialist jobs in gainesville, fl

Senior Quality Specialist, Quality Operations

Test Engineer - Fluids | New Glenn (Mid to Senior | D and 3rd Shift)

Senior Human Resources Business Partner in Gainesville, FL

Cath Lab Tech Lead

Senior Cyber Security Specialist, Technology and Digital, FT,8:30A - 5P

Patient Representative

Senior Public Relations Specialist

Medical Record Technician (Coder-Outpatient and Inpatient)

Researcher III

FOOD CONTROL SPECIALIST - TRAY LINE - 67013476

CCP Operations & Monitoring Specialist

AR Resolution Specialist Lead

Training Specialist

Home Health Coder II

Clinical Research Coordinator I - Neuromuscular Division

Senior Biologist

Move Specialist - Packing, Unpacking, Sorting (Part-time)

Senior Casualty Claims Specialist, Attorney Represented - Southeast

Licensed Practical Nurse - LPN

Medical Assistant

I want to receive the latest job alert for senior quality specialist in gainesville, fl

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