Quality Control Manager
1 month ago
Job Title: Quality Control Bioassay and Virology Operations Lead
Position Summary:
This role is responsible for the daily management and operations of the QC Bioassay and Virology Testing team within the QC Operations department, supporting clinical and commercial AAV-based products. Key responsibilities include overseeing cGMP processes such as in-process, lot release, stability, and raw material testing. The role also involves managing quality systems, including deviations, CAPAs, OOS, change controls, and data integrity, as well as supporting audit readiness and ensuring team training. The position includes managing, coaching, and developing a team of 4+ analysts across various experience levels.
Key Responsibilities:
- Maintain a compliant, efficient, and safe cGMP laboratory in accordance with regulatory, site, and corporate standards.
- Manage daily QC operations for cGMP routine and non-routine testing of in-process samples, drug substances, final products, virus banks, and cell banks.
- Review and approve equipment validation protocols, ensuring all QC instrumentation remains validated and compliant.
- Manage QC supplies, including critical reagents and controls.
- Support method validation and facilitate analytical technology transfers in collaboration with QC Technical Services and QA.
- Lead quality management systems such as Change Controls, Deviations, OOS, CAPA, and other essential processes.
- Author or review detailed documentation including retest protocols, investigations, CMC regulatory sections, SOPs, and more.
- Oversee data and KPI trending to maintain quality metrics.
- Conduct risk assessments to support QC Operations and ensure regulatory compliance for both internal and external audits.
- Drive continuous improvements in processes and procedures to enhance compliance and efficiency.
- Represent QC at cross-departmental meetings and maintain strong relationships with key stakeholders.
- Train and develop team members to meet business needs and career goals.
Requirements:
- Bachelor’s degree in Life Sciences or Engineering.
- 10-15 years of experience in cGMP QC testing within Bioanalytical/Bioassay/Virology, with 8-10 years of leadership experience.
- Technical expertise in large molecule, gene, or cell therapy; cell culture experience required.
- Strong analytical, problem-solving, communication, organizational, and time-management skills.
- Proven ability to mentor and develop staff and work collaboratively with diverse teams.
Physical Requirements:
- Frequently work in a BSL-2 environment with appropriate PPE and aseptic techniques.
- Regular exposure to large machinery, typical pharmaceutical utilities, and occasionally to mechanical parts, high areas, hazardous chemicals, and loud noise levels.
- Frequent standing, walking, and lifting up to 25 pounds; occasional lifting up to 50 pounds.
- Strong close vision and communication abilities necessary.
-
Quality Control Manager
1 month ago
Lexington, United States TalentCraft Full timeJob Title: Quality Control Bioassay and Virology Operations LeadPosition Summary:This role is responsible for the daily management and operations of the QC Bioassay and Virology Testing team within the QC Operations department, supporting clinical and commercial AAV-based products. Key responsibilities include overseeing cGMP processes such as in-process,...
-
Quality Control Manager
2 months ago
Lexington, United States TalentCraft Full timeJob Title: Quality Control Bioassay and Virology Operations LeadPosition Summary:This role is responsible for the daily management and operations of the QC Bioassay and Virology Testing team within the QC Operations department, supporting clinical and commercial AAV-based products. Key responsibilities include overseeing cGMP processes such as in-process,...
-
Quality Control Manager
7 months ago
Lexington, United States Choctaw Global Full timeJOB SUMMARY/OBJECTIVE: The Quality Assurance Manager holds an instrumental role in safeguarding the integrity and compliance of logistical management and facility service maintenance operations, ensuring adherence to stringent government regulations and quality standards. The ideal candidate will possess proactive leadership skills, an innate passion for...
-
Quality Control and Training Manager
2 days ago
Lexington, Kentucky, United States Kentucky Blood Center Inc Full timeResponsibilitiesCoordinate with the Testing Laboratory Manager to develop, administer, and evaluate proficiency and competency evaluations.Train new and existing employees on quality control and assurance procedures.Monitor and maintain quality control and assurance records.Collaborate with other departments to ensure compliance with regulatory requirements.
-
Quality Administrator/Document Controller
1 week ago
Lexington, United States {w[l]=w[l]|[];w[l].push.getTime,event:'gtm.js'});var f Full timeQuality Administrator/Document Controller New Resource Recruitment are happy to announce we are assisting a financially strong Global Engineering Organisation in securing fulltime and permanent Quality Administrator/Document Controller. Based in the Melksham area, they offer good long-term prospects for those looking to build their career and skills base....
-
Virtual Quality Control Inspector
3 weeks ago
Lexington, United States Xometry Full timeXometry (NASDAQ: XMTR) powers the industries of today and tomorrow by connecting the people with big ideas to the manufacturers who can bring them to life. Xometry's digital marketplace gives manufacturers the critical resources they need to grow their business while also making it easy for buyers at Fortune 1000 companies to tap into global manufacturing...
-
Virtual Quality Control Inspector
1 month ago
Lexington, United States Xometry Full timeXometry (NASDAQ: XMTR) powers the industries of today and tomorrow by connecting the people with big ideas to the manufacturers who can bring them to life. Xometry's digital marketplace gives manufacturers the critical resources they need to grow their business while also making it easy for buyers at Fortune 1000 companies to tap into global manufacturing...
-
Virtual Quality Control Inspector
4 weeks ago
Lexington, United States Xometry Full timeXometry (NASDAQ: XMTR) powers the industries of today and tomorrow by connecting the people with big ideas to the manufacturers who can bring them to life. Xometry's digital marketplace gives manufacturers the critical resources they need to grow their business while also making it easy for buyers at Fortune 1000 companies to tap into global manufacturing...
-
Virtual Quality Control Inspector
1 month ago
Lexington, United States Xometry Full timeXometry (NASDAQ: XMTR) powers the industries of today and tomorrow by connecting the people with big ideas to the manufacturers who can bring them to life. Xometry's digital marketplace gives manufacturers the critical resources they need to grow their business while also making it easy for buyers at Fortune 1000 companies to tap into global manufacturing...
-
Quality Assurance Manager
2 days ago
Lexington, Kentucky, United States Schneider Electric USA, Inc Full timeAt Schneider Electric USA, Inc., we are seeking a highly motivated and experienced Manufacturing Quality Engineer to support our end-to-end manufacturing operations in Lexington, KY.About the Role:This position is responsible for leading problem-solving initiatives regarding internal and external customer concerns utilizing tools such as 8D, Kaizen, Six...
-
Production Control Manager
1 month ago
Lexington, United States ElectraMet Full timeThe very technologies that are creating a more sustainable future for us — electric vehicles, semiconductors, and solar panels — are built on a foundation of metals extracted from the earth at great financial and environmental cost. At ElectraMet® our mission is to build a circular economy that reduces our dependence on extracting these...
-
Production Control Manager
1 month ago
lexington, United States ElectraMet Full timeThe very technologies that are creating a more sustainable future for us — electric vehicles, semiconductors, and solar panels — are built on a foundation of metals extracted from the earth at great financial and environmental cost. At ElectraMet® our mission is to build a circular economy that reduces our dependence on extracting these...
-
Production Control Manager
1 month ago
Lexington, United States ElectraMet Full timeThe very technologies that are creating a more sustainable future for us — electric vehicles, semiconductors, and solar panels — are built on a foundation of metals extracted from the earth at great financial and environmental cost. At ElectraMet® our mission is to build a circular economy that reduces our dependence on extracting these...
-
Production Control Manager
1 month ago
lexington, United States ElectraMet Full timeThe very technologies that are creating a more sustainable future for us — electric vehicles, semiconductors, and solar panels — are built on a foundation of metals extracted from the earth at great financial and environmental cost. At ElectraMet® our mission is to build a circular economy that reduces our dependence on extracting these...
-
Injection Molding Quality Manager
2 months ago
lexington, United States United Employment Group, Inc. Full timeESSENTIAL DUTIES, TASKS AND RESPONSIBILITIES: These are duties that the person holding this job MUST be able to perform.Manage the day-to-day operations of the Quality Department, while providing clear direction to all functional subordinates to ensure the location meets its internal and external quality objectives.• Ensure the implementation of effective...
-
Injection Molding Quality Manager
1 month ago
Lexington, United States United Employment Group, Inc. Full timeESSENTIAL DUTIES, TASKS AND RESPONSIBILITIES: These are duties that the person holding this job MUST be able to perform.Manage the day-to-day operations of the Quality Department, while providing clear direction to all functional subordinates to ensure the location meets its internal and external quality objectives.• Ensure the implementation of effective...
-
Injection Molding Quality Manager
6 months ago
Lexington, United States United Employment Group, Inc. Full timeESSENTIAL DUTIES, TASKS AND RESPONSIBILITIES: These are duties that the person holding this job MUST be able to perform.Manage the day-to-day operations of the Quality Department, while providing clear direction to all functional subordinates to ensure the location meets its internal and external quality objectives.• Ensure the implementation of effective...
-
Lexington, Kentucky, United States Lexmark International Inc Full timeJob Title: Project EngineerAbout Us:Lexmark International Inc is a global technology leader in document management and printing solutions. Our commitment to innovation, quality, and customer satisfaction has made us a trusted partner for businesses and individuals worldwide.Salary: $150,000 - $200,000 per year (depending on experience)Job Summary:As a...
-
Quality Control Analyst
3 weeks ago
Lexington, United States LanceSoft, Inc. Full timeqPCR experience is required.Job Summary/Operations Involvement:Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies.Testing may include but not limited to samples from drug substances and drug product manufacturing, stability and various protocol...
-
Quality Control Analyst
3 weeks ago
Lexington, United States LanceSoft, Inc. Full timeqPCR experience is required.Job Summary/Operations Involvement:Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies.Testing may include but not limited to samples from drug substances and drug product manufacturing, stability and various protocol...