Top 41 Senior regulatory technical 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
Quick Apply
5d
Business Process Red Team Operator
JPMorganChase —Columbus, OH
- $156,750 - $260,000 a year
- Full-time
- 5 years
- Research
- Windows
- Health insurance
- Tuition reimbursement
Sr. Field Applications Specialist - Chemistry/Immunoassay - 95% Travel
Beckman Coulter Diagnostics —Columbus, OH
- $40 - $46 an hour
- Full-time
- Clean driving record
- Ability to walk for extended periods
- Ability to climb stairs
- Health insurance
- Dental insurance
Commissioning / Qualification / Validation Specialist
Salas O'Brien, Inc. —Columbus, OH
- $90,000 - $100,000 a year
- Hybrid work
- Microsoft Excel
- 5 years
- Data analysis skills
- Paid holidays
- Health insurance
14d
Absence Management Specialist - HCM Senior Analyst
State of Ohio - Behavioral Health —Columbus, OH
- $32.35 an hour
- Online Application
- Background check
- Databases
- Analysis skills
- Paid holidays
- Disability insurance
Senior Payment Operations Specialist
Western Alliance Bank —Columbus, OH
- $26.40 - $32.61 an hour
- Full-time
- Writing skills
- Research
- Mid-level
- Wellness program
- Health insurance
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
14d
Principal Clinical Specialist
Abbott Laboratories —Columbus, OH
- $86,700 - $173,300 a year
- Full-time
- 6 years
- Senior level
- Health insurance
- Tuition reimbursement
4d
Screening Adjudication Expert
Klarna Bank AB —Columbus, OH
- $77,539 - $110,884 a year
- Full-time
- 5 years
- Senior level
- Communication skills
- Health insurance
- Dental insurance
10d
Sr Payroll Specialist
DHL —Westerville, OH
- Senior level
- Communication skills
5d
Cyber AI Governance and Privacy Senior Consultant
Deloitte —Columbus, OH
- $105,400 - $207,800 a year
- Full-time
- Up to 50% travel
- Bachelor's degree
- Travel
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
Senior Manager - ServiceNow
Deloitte —Columbus, OH
- $163,400 - $322,100 a year
- Full-time
- Computer Science
- Up to 50% travel
- Bachelor of Science
Electron Microscopy Specialist 2 - Pathology - Days
The Ohio State University Wexner Medical Center —Columbus, OH
- Online Application
- Background check
- Pass drug screening
- Mid-level
8h
Microsoft Purview and Data Governance Senior Consultant
Deloitte —Columbus, OH
- $105,400 - $207,800 a year
- Full-time
- Computer Science
- Up to 50% travel
- 3 years
Audit - Valuation & Analytics - AI Specialist
Deloitte —Columbus, OH
- $67,950 - $136,375 a year
- Full-time
- Computer Science
- Office
- Finance
4d
Senior Project Engineer - Conveyance and Infrastructure Rehabilitation
Brown and Caldwell —Columbus, OH
- $128,000 - $191,000 a year
- Hybrid work
- Background check
- Pass drug screening
- Supervising experience
- Paid holidays
- Disability insurance
Cyber ServiceNow - Senior Consultant
Deloitte —Columbus, OH
- $105,400 - $207,800 a year
- Full-time
- Remote
- Computer Science
- Up to 50% travel
- Mid-level
Senior Construction Safety Professional
AECOM —Columbus, OH
- $120,000 - $150,000 a year
- Full-time
- Construction site
- Bachelor of Science
- 8 years
- AD&D insurance
- Employee stock purchase plan
Senior Oncology Specialist - Sapphire - Columbus, OH
Amgen —Columbus, OH
- $140,465 - $190,041 a year
- 3 years
- High school diploma or GED
- Bachelor's degree
- Disability 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 regulatory technical specialist jobs in columbus

Senior Quality Assurance Specialist - Investigations

Business Process Red Team Operator

Sr. Field Applications Specialist - Chemistry/Immunoassay - 95% Travel

Commissioning / Qualification / Validation Specialist

Absence Management Specialist - HCM Senior Analyst

Senior Payment Operations Specialist

Senior Data Scientist

Principal Clinical Specialist

Screening Adjudication Expert

Sr Payroll Specialist

Cyber AI Governance and Privacy Senior Consultant

CRE Loan Closing Specialist - Senior

Senior Manager - ServiceNow

Electron Microscopy Specialist 2 - Pathology - Days

Microsoft Purview and Data Governance Senior Consultant

Audit - Valuation & Analytics - AI Specialist

Senior Project Engineer - Conveyance and Infrastructure Rehabilitation

Cyber ServiceNow - Senior Consultant

Senior Construction Safety Professional

Senior Oncology Specialist - Sapphire - Columbus, OH

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