Top 23 Quality assurance manager Jobs in Lincolnton, Nc

HAL Quality Manager
BioCytics Inc —Huntersville, NC
- Full-time
- Background check
- Pass drug screening
- 3 years
- Health insurance
- Dental insurance
Quick Apply
Quality Lead
Steel Warehouse —Hickory, NC
- $40,000 - $50,000 a year
- Full-time
- Background check
- ERP systems
- Mid-level
- Health savings account
- Health insurance
Quick Apply
Quality Assurance Manager
UTZ Brands, Inc —Kings Mountain, NC
- Full-time
- 3 years
- Bachelor's degree
- Experience equivalent to degree accepted
- Profit sharing
- Health insurance
19h
Quality Manager
Eaton —Kings Mountain, NC
- $130,000 - $190,000 a year
- Full-time
- Background check
- 5 years
- Engineering
- Retirement plan
5d
Manager, Qualification
AptarGroup, Inc. —Lincolnton, NC
- 5 years
- Engineering
- English
Quality Manager
Zion Industries —Hildebran, NC
- From $75,000 a year
- Full-time
- Mid-level
- US work authorization
- In-person
- Health insurance
- Dental insurance
Quick Apply
3d
Quality Manager
Wanzl NA —Denver, NC
- Management
- Engineering
- Travel
Quick Apply
4d
Food Safety Quality Assurance Supervisor
TheogCompanies —Bessemer City, NC
- $79,000 - $82,000 a year
- Overtime
- Microsoft Access
- Management
- Research
Quick Apply
Project Quality Completions Manager
Zachry Group —Terrell, NC
- Full-time
- 5 years
- Bachelor's degree
- Senior level
Quality Management Systems Coordinator
Magnera Corporation —Charlotte, NC
- Full-time
- Mid-level
- Analysis skills
- Business Administration
Warranty Inspection Supervisor
Yokohama Tire Corporation —Cornelius, NC
- $80,000 - $90,000 a year
- 4 hour shift
- Forklift
- Supervising experience
- Bachelor's degree
11d
Supervisor, Operations
Southwire Company LLC —Huntersville, NC
- Overtime
- High school diploma or GED
- Team management
- Warehouse
- Paid holidays
- Disability insurance
4d
Quality Manager, Aerospace & Defense
DAE Systems —Claremont, NC
- $85,000 - $110,000 a year
- Full-time
- Background check
- Mentoring
- In-person
- Health insurance
- Dental insurance
Quick Apply
(Electrical) QA/QC Project Manager- Data Center Construction
Turner & Townsend —Maiden, NC
- Full-time
- Microsoft Outlook
- Construction site
- 5 years
Quick Apply
QC Deputy Manager - Bilingual in Mandarin
Green New Energy Materials —Denver, NC
- From $70,000 a year
- Full-time
- Background check
- Ability to walk for extended periods
- Writing skills
- Health insurance
- Dental insurance
Quick Apply
Inspections Operations Leader
PFS TECO An NFPA Global Solutions Company —United States
- Mid-level
- Residential
- High school diploma or GED
Quick Apply
Quality Control Manager- Dam Project
Thalle Construction Company —United States
- Full-time
- Construction site
- Senior level
- Professional Engineer
- Paid holidays
- Disability insurance
Quick Apply
7d

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HAL Quality Manager

BioCytics Inc
Huntersville, NC

Quick Apply

Job Details

Full-time

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance

Qualifications

Team leadership
Corrective and preventive actions (CAPA)
Supervising experience
Bachelor's degree
Quality risk management
Biomedical regulatory compliance
Laboratory staff supervision
Quality audits
GMP for research safety and compliance
Managing product quality assurance teams
Supplier quality assurance (SQA)
FDA regulations
Customer complaint resolution

Full Job Description

The Human Applications Laboratory (HAL) Quality Manager is responsible for leading the development, implementation, and ongoing maturation of the Quality Management System (QMS) supporting GMP and GLP operations for cellular immunotherapy products, including immune cells, within the Human Applications Laboratory (HAL). This position will establish the quality infrastructure necessary to support compliant laboratory operations by developing quality processes, Standard Operating Procedures (SOPs), Quality Control (QC) programs, controlled documentation, training programs, and quality records in accordance with applicable FDA regulations, current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and internal quality standards.

Responsibilities:

Quality Management System (QMS)

· Lead the development, implementation, maintenance, and continuous improvement of the Human Applications Laboratory (HAL) Quality Management System (QMS) supporting GLP and GMP operations.

· Develop, implement, and monitor quality policies, procedures, forms, and work instructions to ensure compliance with applicable regulatory requirements and industry standards.

· Ensure compliance with Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Tissue Practices (GTP), Good Documentation Practices (GDP), and other applicable regulations and accreditation standards.

· Partner with laboratory leadership to establish quality objectives, quality metrics, and continuous improvement initiatives.

Document Control and Quality Records

· Develop, review, approve, revise, and maintain SOPs, batch records, controlled forms, specifications, validation documentation, and other quality records.

· Ensure timely and accurate completion, review, and retention of GMP and GLP documentation, including laboratory records, batch records, equipment logs, training records, QC documentation, and quality reports.

· Maintain document control processes and ensure version control of all controlled documents.

Quality Assurance and Quality Control

· Support the QC Specialist in the development of and oversee the Quality Control (QC) programs for laboratory operations and cellular therapy manufacturing.

· Review and approve analytical testing, reagent verification, equipment qualification, process validation, environmental monitoring, and batch documentation.

· Review and approve material receipt, inspection, release, Certificates of Analysis (COAs), Safety Data Sheets (SDS), and product disposition.

· Monitor quality performance through quality indicators, QC charts, monthly quality monitors, and trend analysis.

Quality Systems

· Manage deviations, nonconformances, investigations, Root Cause Analyses (RCA), Corrective and Preventive Actions (CAPA), Change Control, and risk assessments.

· Perform trend analysis of quality data to identify recurring issues, systemic risks, and opportunities for process improvement.

· Prepare quality metrics, management reports, and quality summaries for leadership review.

· Maintain inspection readiness and facilitate internal, customer, vendor, and regulatory inspections.

Supplier and Regulatory Quality

· Develop and maintain supplier qualification and supplier monitoring programs.

· Investigate customer complaints and coordinate appropriate quality actions.

· Support regulatory inspections, accreditation activities, and customer audits, including responses to findings and implementation of corrective actions.

· Ensure compliance with FDA regulations, AABB Standards, FACT Standards, and other applicable regulatory requirements.

Training and Personnel Qualification

· Develop and maintain quality training, orientation, competency assessment, and personnel qualification programs.

· Ensure personnel training and competency records remain current and compliant.

· Support qualification of personnel for GMP activities, including aseptic processing, as applicable.

Laboratory Operations Support

· Collaborate with the HAL team to ensure GMP processes for the isolation, processing, expansion, characterization, and storage of immune cells are compliant.

· Support development, validation, qualification, and continuous improvement of laboratory processes, equipment, biobanking and manufacturing workflows.

· Support FDA IND-enabling activities and Phase I clinical trial manufacturing through quality oversight and documentation review.

Technical Laboratory Responsibilities

· Oversee quality review of bioanalytical testing, including flow cytometry, cell counting, microscopy, immunomagnetic cell selection, fluorescence-activated cell sorting (FACS), and related laboratory techniques, as required.

· Ensure appropriate equipment qualification, calibration, maintenance, and documentation.

Operational Support

Perform additional Quality duties and special projects as assigned.

Qualifications:

Minimum of 7 years of progressive experience in regulated quality systems.
Demonstrated experience developing and implementing GMP Quality Management Systems.
Cell therapy or biologics experience.
Startup GMP facility experience.
Experience supporting FDA inspections.
Experience with deviations, CAPA, Change Control, document control, risk management, training, supplier qualification, and internal auditing.
FACT or AABB experience preferred.
Minimum of 3 years of leadership experience supervising quality personnel. Supervisory required, management preferred

Education Requirements:

Bachelor's degree in a scientific, engineering, or related discipline required.
Preferred: ASQ certification

Work Location:

One location

Work Remotely:

Job Type: Full-time

Benefits:

401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance

Application Question(s):

Are you willing to undergo a background check, in accordance with local law/regulations?
Are you willing to take a drug test, in accordance with local law/regulations?
Will you now or in the future require employer-sponsored work authorization (e.g., H-1B visa sponsorship) to work in the United States?

Education:

Bachelor's (Required)

Experience:

supervisory: 3 years (Required)
regulated quality systems: 7 years (Required)

License/Certification:

ASQ certification (Preferred)

Ability to Commute:

Huntersville, NC 28078 (Required)

Work Location: In person

Quick Apply

Refine Your Search

quality assurance manager jobs in lincolnton, nc

HAL Quality Manager

Quality Lead

Quality Assurance Manager

Quality Manager

Manager, Qualification

Quality Manager

Quality Manager

Food Safety Quality Assurance Supervisor

Project Quality Completions Manager

Quality Management Systems Coordinator

Warranty Inspection Supervisor

Supervisor, Operations

Quality Manager, Aerospace & Defense

(Electrical) QA/QC Project Manager- Data Center Construction

QC Deputy Manager - Bilingual in Mandarin

Inspections Operations Leader

Quality Control Manager- Dam Project

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