Top 28 Senior quality assurance specialist Jobs in Columbus

Senior Quality Assurance Specialist - Investigations
Andelyn Biosciences, Inc —Columbus, OH
- Full-time
- Microsoft Excel
- Bachelor's degree
- Continuous improvement
- Paid parental leave
- Paid holidays
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5d
Senior Specialist, Data Analytics - Category Planning
Cardinal Health —Dublin, OH
- $68,500 - $88,020 a year
- Finance
- SQL
- Analysis skills
- Paid parental leave
- Health savings account
Sr Quality Improvement/HEDIS Spec, Health Plan Interventions (Remote In Ohio)
Molina Healthcare —Columbus, OH
- $54,922 - $107,099 a year
- Full-time
- Remote
- RN License
- Writing skills
- Analysis skills
- Health insurance
Commercial Lines Quality Assurance Senior Specialist (hybrid/remote)
Grange Insurance Company —Columbus, OH
- Remote
- 7 years
- Analysis skills
- Bachelor's degree
- Bereavement leave
13d
Specialist I, QA Operations
Forge Biologics —Columbus, OH
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Mid-level
- Paid parental leave
- Disability insurance
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9d
SUPPLY CHAIN SPECIALIST
Brewdog —Canal Winchester, OH
- Microsoft Excel
- Computer literacy
- Mid-level
- Parental leave
- Employee assistance program
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Micro Specialist
Brewdog —Canal Winchester, OH
- Mentoring
- Entry level
- Time management
- Parental leave
- Employee assistance program
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IT Functional Manager-NetSuite Order Management
Orveon Global US LLC —Columbus, OH
- $98,000 - $130,500 a year
- Full-time
- Hybrid work
- Computer science
- Computer Science
- 5 years
- Opportunities for advancement
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Micro Specialist
BrewDog USA Inc —Canal Winchester, OH
- $22 - $24 an hour
- Full-time
- Mentoring
- In-person
- Entry level
- Health insurance
- Dental insurance
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Collection Specialist
Phillips & Cohen Associates Ltd. —Gahanna, OH
- From $20 an hour
- Full-time
- Hybrid work
- Microsoft Excel
- High school diploma or GED
- Analysis skills
- Free parking
- Health insurance
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Financial Crime Compliance Specialist
Klarna Bank AB —Columbus, OH
- $105,394 - $132,206 a year
- Full-time
- English
- Analysis skills
- Senior level
- Health insurance
- Dental insurance
9d
Senior Design Specialist
Salas O'Brien, Inc. —Dublin, OH
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Engineering
Senior Data Scientist
Accenture —Columbus, OH
- $87,400 - $293,800 a year
- Full-time
- Hybrid work
- Azure
- 6 years
- Doctoral degree
- Paid holidays
- Disability insurance
13d
Specialist Manager, Engagement Matters
Deloitte —Columbus, OH
- $93,000 - $171,300 a year
- Full-time
- CPA
- 5 years
- Research
CRE Loan Closing Specialist - Senior
Huntington Bank —Columbus, OH
- $70,000 - $140,000 a year
- Full-time
- Office
- Analysis skills
- Bachelor's degree
- Wellness program
- Paid holidays
Audit - Valuation & Analytics - AI Specialist
Deloitte —Columbus, OH
- $67,950 - $136,375 a year
- Full-time
- Computer Science
- Office
- Finance
3d
Senior Manufacturing Engineer, Altius
Anduril Industries —Ashville, OH
- $126,000 - $167,000 a year
- Email
- Data analysis skills
- Senior level
- Commercial
Quick Apply
Regional Director of Community Engagement and Experience
National Church Residences —Dublin, OH
- Full-time
- Experience working with individuals with disabilities
- Computer literacy
- English
Quick Apply
Lead Software Engineer - Python/React, Ansible, RHEL
JPMorganChase —Columbus, OH
- $123,500 - $175,000 a year
- Full-time
- 5 years
- Senior level
- Leadership
- Health insurance
- Tuition reimbursement
AMER Commissioning Electrical SME, AMER Commissioning
Amazon Data Services, Inc. —Columbus, OH
- $136,600 - $184,800 a year
- Full-time
- 7 years
- Engineering
- Research
- AD&D insurance
- Health insurance

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Senior Quality Assurance Specialist - Investigations

Andelyn Biosciences, Inc -
Columbus, OH

Quick Apply

Job Details

Full-time
5 days ago

Benefits

Paid parental leave
Paid holidays
Disability insurance
Health insurance
Dental insurance
Tuition reimbursement
Paid time off
Adoption assistance
Parental leave
Employee assistance program
Vision insurance
401(k) matching
Loan assistance
Life insurance

Qualifications

Content creation for technical audiences
Pharmaceutical regulatory compliance
Drug regulation
Technical writing experience within manufacturing
Corrective and preventive actions (CAPA)
Manufacturing standard operating procedures
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
Technical project management
Productivity software
Cross-functional collaboration
Standard operating procedures (SOPs)
Cross-functional communication
Standard operating procedures drafting
Pharmaceutical manufacturing facility experience

Full Job Description

Overview of Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization. Located in Columbus, OH, the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities.

Our Values are founded in our origin story.

The name “Andelyn” is a hybrid of two gene therapy patients who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible.

Through this journey, we have been able to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Pioneering Solutions that Turn Hope Into Reality™ through our ACCTSions.

ACCOUNTABLE in our actions.

CURIOUS to discover.

COMPASSIONATE in our thinking.

TRUSTWORTHY in our communications.

SUPPORTIVE of one another.

Employees are expected to perform the following essential functions under the framework of our ACCTSions.

What you will do.

The Senior QA Specialist, QA Investigations/CAPA is an individual contributor role primarily responsible for conducting technical quality compliance-related activities in accordance with GxP regulations and internal SOP. This SME ensures deviations are thoroughly investigated, the root cause is determined, and appropriate corrective actions are identified and implemented based on associated risk to process, compliance or SISPQ. Additionally, the individual is responsible for the oversight and communication of critical metrics regarding deviations and CAPAs. The individual also provides QA review and oversight of Trend Review Reports to identify interrelationships between process inputs and critical process parameters and to identify process shifts.

Oversee and support the prompt evaluation, investigation, closure, and follow-up of unplanned events as well as identify opportunities for continuous improvements.
Works with SMEs to ensure thorough root cause analyses, assess impact to SISPQ, and ensures root cause is addressed through appropriate Corrective/Preventive Actions.
Works to establish appropriate ownership and timelines for CAPAs about the risk related to the event or issue.
Assesses final supporting documentation to complete/close CAPAs as adequate. Conducts CAPA effectiveness checks for high-risk events.
Communicates critical metrics regarding deviations and CAPAs and chairs the Investigation Review Board meeting.
Provide oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.
Acts as the SME and trainer for the TrackWise Investigation/CAPA module.
Prepares and reports quality metrics as necessary to ensure upper management is aware of trends and ongoing activities relevant to investigations, CAPA, etc.
Ensures that documentation is maintained in accordance with internal procedures and regulatory requirements.
Assess accuracy and compliance of procedures as an SOP author, reviewer, and approver and work with cross-functional approval panels for timely, accurate document revisions.
Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.
Performs the function of Senior QA Specialist and other related assignments and duties as required and assigned.

What you bring to the team.

Minimum of 5 years’ experience GMP/Biopharmaceutical/Biotech Industry/FDA, 3-5 years specific QA hands-on experience in a pharmaceutical environment, cell and gene therapy experience preferred.
Bachelor’s Degree in a technical or scientific discipline or equivalent • Operational knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211
Demonstrated Project Management abilities to lead and manage several projects, meeting deadlines, and use critical thinking skills to problem solve effectively.
Excellent verbal and written communication skills at all levels of the organization. Technical writing is required.
Experience with the authoring and execution of Quality documentation including SOPs, CAPAs, and Investigations.
Experience with FDA, and EMA inspection interaction.
Strong experience working in cross-functional teams. Ability to influence, negotiate, manage conflict, and collaborate.
Must demonstrate a “can-do” attitude. • Proficient in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint). Knowledge of application software such as Trackwise, and SAP, preferred.

What you can expect when working at Andelyn.

The pride of contributing to the development and manufacturing of life-saving therapies
The invaluable experience of being a part of building the foundation of a new organization.
The opportunity to work alongside experts that have over 10 years in the gene therapy field.
Competitive compensation
Eligible day one for medical, dental and vision insurance plans with basic vision at 100% company-paid
160 hours of Paid Time Off annually
11 Company Paid Holidays plus 2 floating holidays annually.
Company Paid Life Insurance
401(k) Match
Company Paid short and long-term disability.
4 weeks of Paid Parental Leave for birth and adoption
Adoption Assistance
Tuition Reimbursement and Student Loan Repayment Assistance
Company Paid LinkedIn Learning access.
Employee Assistance Programs
Flexible work options (role specific)

Andelyn Biosciences embraces diversity and is an equal opportunity employer and does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status. As an organization, we are committed to creating an environment where everyone ACCTS.

Quick Apply

Refine Your Search

senior quality assurance specialist jobs in columbus

Senior Quality Assurance Specialist - Investigations

Senior Specialist, Data Analytics - Category Planning

Sr Quality Improvement/HEDIS Spec, Health Plan Interventions (Remote In Ohio)

Commercial Lines Quality Assurance Senior Specialist (hybrid/remote)

Specialist I, QA Operations

SUPPLY CHAIN SPECIALIST

Micro Specialist

IT Functional Manager-NetSuite Order Management

Micro Specialist

Collection Specialist

Financial Crime Compliance Specialist

Senior Design Specialist

Senior Data Scientist

Specialist Manager, Engagement Matters

CRE Loan Closing Specialist - Senior

Audit - Valuation & Analytics - AI Specialist

Senior Manufacturing Engineer, Altius

Regional Director of Community Engagement and Experience

Lead Software Engineer - Python/React, Ansible, RHEL

AMER Commissioning Electrical SME, AMER Commissioning

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