Top 2096 Quality assurance specialist ii, device Jobs in Columbus

QA Change Control Specialist II
American Regent, Inc. —New Albany, OH
- Overtime
- Microsoft Excel
- Mid-level
- Office
14d
Quality Specialist
US AMR-Jones Lang LaSalle Americas, Inc. —New Albany, OH
- $67,000 - $97,000 a year
- Online Application
- Word processing
- Computer literacy
- Mid-level
- Paid parental leave
- Paid holidays
Quick Apply
Technology Integration Specialist
Groveport Madison School District —Groveport, OH
- $55,746.46 - $83,111.00 a year
- Full-time
- Background check
- Google Workspace
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Principal Specialist, Quality Assurance - Microbiology
Cardinal Health —Lewis Center, OH
- $80,900 - $103,950 a year
- Bachelor's degree
- No degree
- Mentoring
- Paid parental leave
- Health savings account
Test Technician - TSA Acceptance Testing
Battelle —Columbus, OH
- $29 - $41 an hour
- Weekends as needed
- Hybrid work
- Computer literacy
- Maintenance
- Mid-level
- Wellness program
- Health insurance
Specialist, Quality Operations
Safecor Health —Columbus, OH
- English
- Mid-level
- 3 years
5d
Clinical Athletic Trainer - Musculoskeletal - $5,000 Signing Bonus
Ohio State University Physicians —Columbus, OH
- $24.05 - $35.76 an hour
- Full-time
- BLS Certification
- Clinic experience
- Outpatient experience
- Wellness program
- Paid holidays
HVAC Service Tech III(Columbus)
Polk Mechanical Company —Columbus, OH
- $45 - $58 an hour
- Full-time
- OSHA
- High school diploma or GED
- Driver's License
- Paid holidays
- Disability insurance
Quick Apply
Ultrasound Technologist
Life Line Screening —Columbus, OH
- $55,000 - $65,000 a year
- Overtime
- Background check
- Pass drug screening
- Driver's License
- Paid holidays
- Disability insurance
6d
Field Service Manager Columbus, OH (Heath)
BearCom —Worthington, OH
- On call
- Microsoft Excel
- Microsoft Outlook
- Customer service
- Paid holidays
- Disability insurance
Quick Apply
Security Low Voltage Technician
PLUGOUT —Dublin, OH
- $25 - $35 an hour
- Full-time
- Construction site
- Mid-level
- Mentoring
- Health insurance
- Dental insurance
Quick Apply
Merchandiser - PT
McClatchy Media —Columbus, OH
- $15 an hour
- Overtime
- Background check
- Merchandising
- Pass drug screening
- Employee assistance program
- 401(k) matching
Assembly Team Member - 1st Shift - $1000 Hiring Bonus
Rogue Fitness —Columbus, OH
- $21 - $22 an hour
- Overtime
- Background check
- Pass drug screening
- English
- 401(k)
Personal Vehicle Delivery Driver
Saginaw Delivery Corporation —Grove City, OH
- From $11 an hour
- Part-time
- Background check
- Clean driving record
- Driver's License
Quick Apply
Local CDL A Driver - 3K Sign On Bonus
Red Classic Transportation —Lockbourne, OH
- $0.66 - $0.72 per mile
- Urgently hiring
- No touch freight
- Local
- CDL A
- Fuel card
- Paid holidays
9d
BAS Controls Service Technician - L2
CMS Controls - Ohio —Columbus, OH
- $40 - $60 an hour
- Full-time
- 3 years
- Ability to lift 50 pounds
- Driver's License
Quick Apply
Delivery Driver
Superhero Logistics LLC —Lockbourne, OH
- $21.75 an hour
- Full-time
- Customer service
- Ability to climb stairs
- Ability to lift 50 pounds
- Paid training
- Health insurance
Quick Apply
Industrial Electrical Field Technician-Nationwide Travel
Electrical Power and Safety Company —Columbus, OH
- $35 - $38 an hour
- Full-time
- Up to 50% travel
- Military
- Mid-level
- Travel reimbursement
- Health savings account
Quick Apply
8d
Experienced 26' Box Truck Drivers - Columbus, OH
Lia Corp —Columbus, OH
- $0.50 per mile
- Weekends as needed
- Dedicated
- Customer service
- Mid-level
- Fuel card
- Referral program
Quick Apply
Certified Occupational Therapy Assistant (COTA)
Westerville Post Acute —Westerville, OH
- Full-time
- CPR Certification
- Ability to walk for extended periods
- BLS Certification
Quick Apply
3d

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quality assurance specialist ii, device jobs near columbus

QA Change Control Specialist II

American Regent, Inc. -
New Albany, OH

Apply Now

Job Details

Full-time
14 days ago

Qualifications

Microsoft Excel
Visio
Bachelor's degree
Productivity software

Full Job Description

Nature and Scope

This position is a member of the Change Control Group and is responsible for implementation of processes and/or changes related to the manufacture of safe, pure, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Change Control Group provides support to other departments as needed and is critical in maintaining production schedules and meeting company goals. The QA Change Control Specialist will participate in all aspects of the Change Control Process. This includes all elements of the change lifecycle such as initiation, assisting all participants, and hand-offs to implementation as per applicable Standard Operating Procedures. The level II position requires an individual to perform tasks autonomously with anticipated lead roles for the detailed responsibilities below. There is minimal direct supervision.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Responsible for the review and approval of change controls, as designee, related to new processes, equipment, material, supplier changes in addition to revisions of documents and creation of new documents.
Assessing the adequacy of submitted change controls.
Independently coordinate with requesting departments to obtain supporting information, resolve change control issues, and facilitate the review/approval/implementation of changes.
Assist users with the electronic document management system for the site. Tasks include training new personnel on the use of the system, and coordinating with GxP and service provider to resolve system issues.
Assessing document drafts for format and content in relation to stated change(s).
Preparing monthly departmental metrics related to change control and document control processes.
Preparing product specific change control reviews for Annual Product Review assessments.
Ensuring the appropriate versions of documents are readily accessible in electronic and/or hard copy form.
Develop, maintain, and facilitate applicable training around the Change Control process and functions. Support preparation of controlled documents through the change control process including proofreading, tracking, and management through completion.
Collaborate and interact with functional areas within the business (Operations, Quality Control, Research & Development etc.).
Work independently and is able to recognize daily needs with minimal supervision while delivering timely results.
Effectively manage multiple tasks while working under pressure.
Providing support for regulatory inspections including tracking inspection requests, retrieving and copying requested documents, and contacting subject matter experts as needed.
Ensure all work is performed and documented in accordance with cGMP requirements and existing company policies and procedures.
Able to independently problem solve, provide investigation support, and support the change management function.
Able to develop and revise Standard Operating Procedures related to the Change Control process.
Establish and maintain quality metrics related to the Change Control process.
Take ownership of continuous improvement initiatives to improve the Change Control process.
Able to provide post-implementation support to all stakeholders and Document Control group.
Perform any other tasks/duties as assigned by management.
We all must embrace the QUALITY culture.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

Bachelor’s Degree required in science related discipline strongly preferred.
Minimum 3 years experience in Quality Assurance function or related field required.
Advanced computer skills to include Microsoft Word, Excel, Access, Visio or comparable software, PowerPoint, email.

Demonstrated analytical and critical thinking skills.
Knowledge of applicable FDA regulations and established expertise in interpreting and applying to the organization required preferred.
Excellent organizational, interpersonal and communication skills (written and oral) required.
Ability to take feedback constructively and function in a team oriented work environment.
Ability to work overtime as needed.

Physical Environment and Requirements

While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.
Ability to work in an office environment including extensive computer activity.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:

All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
Our recruiting process includes multiple in person and/or video interviews and assessments.
If you are unsure about the legitimacy of a message, contact John Rossini at [email protected] before responding.
We never request payment, bank information, or personal financial details during our offer process.

Your security is important to us, and we encourage you to stay vigilant when job searching.

American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [email protected].

Apply Now

Refine Your Search

quality assurance specialist ii, device jobs in columbus

QA Change Control Specialist II

Quality Specialist

Technology Integration Specialist

Principal Specialist, Quality Assurance - Microbiology

Test Technician - TSA Acceptance Testing

Specialist, Quality Operations

Clinical Athletic Trainer - Musculoskeletal - $5,000 Signing Bonus

HVAC Service Tech III(Columbus)

Ultrasound Technologist

Field Service Manager Columbus, OH (Heath)

Security Low Voltage Technician

Merchandiser - PT

Assembly Team Member - 1st Shift - $1000 Hiring Bonus

Personal Vehicle Delivery Driver

Local CDL A Driver - 3K Sign On Bonus

BAS Controls Service Technician - L2

Delivery Driver

Industrial Electrical Field Technician-Nationwide Travel

Experienced 26' Box Truck Drivers - Columbus, OH

Certified Occupational Therapy Assistant (COTA)

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