Top 609 Quality management system Jobs in Bloomington In

Regulatory Affairs Specialist
Singota Solutions —Bloomington, IN
- Full-time
- Hybrid work
- Mid-level
- Microsoft Office
- Bachelor's degree
- Health savings account
- AD&D insurance
SDS Author (Remote)
Pace Analytical Life Sciences —Indiana
- $25 - $27 an hour
- Full-time
- Remote
- Microsoft Excel
- Data analysis skills
- Mid-level
- Wellness program
- Health savings account
10d
QUALITY ASSURANCE TESTER II
Palco —Bloomington, IN
- Remote
- Writing skills
- SQL
- Analysis skills
- Paid training
- AD&D insurance
9d
Work Management Specialist I or II
Duke Energy —Bloomington, IN
- Full-time
- Customer service
- Mid-level
- High school diploma or GED
2d
IT User Support Technician
Indiana University —Bloomington, IN
- Full-time
- Computer literacy
- Mid-level
- Windows
- Paid parental leave
- Health savings account
5h
Retail Customer Service Associate
FedEx Office —Bloomington, IN
- Full-time
- Maintenance
- High school diploma or GED
- Project management
Logistics supervisor
Blackwood Solutions —Bloomington, IN
- Full-time
- Writing skills
- Mid-level
- High school diploma or GED
Quick Apply
Online Grocery Pick-Up Clerk
Kroger —Bloomington, IN
- Part-time
- Basic math
- Adults
- Cash register
- Paid holidays
- Health insurance
Billing Analyst - Hybrid Remote
Hoosier Energy —Bloomington, IN
- Hybrid work
- Computer literacy
- Mid-level
- Bachelor's degree
Production Operator
Tasus Corporation —Bloomington, IN
- 8 hour shift
- High school diploma or GED
- Manufacturing
- Entry level
Quick Apply
Exam Coordinator (Educational Resources Coordinator), Accessible Educational Service
Indiana University —Bloomington, IN
- Full-time
- Customer service
- Mid-level
- Office
- Paid parental leave
- Health savings account
1d
Office Manager- Urology
Indiana University Health —Bloomington, IN
- Full-time
- 5 years
- High school diploma or GED
- Bachelor's degree
Assistant Director of Academic Advising (Academic Advisor)
Indiana University —Bloomington, IN
- $57,000 a year
- Full-time
- Research
- Mid-level
- Office
- Paid parental leave
- Health savings account
8d
Contracts and Grants Specialist
Indiana University —Bloomington, IN
- $65,000 a year
- Full-time
- Mid-level
- Office
- University
- Paid parental leave
- Health savings account
Academic Advisor
Indiana University —Bloomington, IN
- $50,000 a year
- Full-time
- Research
- Mid-level
- Office
- Paid parental leave
- Health savings account
9d
Outside Recovery Associate
Rural King —Bloomington, IN
- Part-time
- Ability to walk for extended periods
- Merchandising
- Forklift
- Health insurance
- 401(k) matching
System Administrator
TCS Inc —Bedford, IN
- Full-time
- 5 years
- High school diploma or GED
- SQL
- Paid holidays
- Disability insurance
Financial Administration Specialist
Indiana University —Bloomington, IN
- $55,000 - $65,000 a year
- Full-time
- Mid-level
- Office
- Finance
- Paid parental leave
- Health savings account
8d
Associate Director (Program Management Specialist)
Indiana University —Bloomington, IN
- $70,000 - $80,000 a year
- Full-time
- Google Workspace
- 5 years
- Office
- Paid parental leave
- Health savings account
8d
Cashier
Rural King —Bloomington, IN
- Part-time
- Computer skills
- Communication skills
- Entry level
- Health insurance
- 401(k) matching

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Regulatory Affairs Specialist

Singota Solutions
Bloomington, IN

Apply Now

Job Details

Full-time

Benefits

Health savings account
AD&D insurance
Paid holidays
Disability insurance
Health insurance
Dental insurance
401(k)
Tuition reimbursement
Paid time off
Employee assistance program
Vision insurance
401(k) matching
Employee discount
Life insurance

Qualifications

Microsoft Office
Attention to detail
Pharmaceutical company experience
Regulatory affairs
Productivity software
Standard operating procedures (SOPs)
Manufacturing company experience
Technical Proficiency

Full Job Description

Why join Team Singota?

We pride ourselves on a high-trust, high-accountability environment where we lift each other up. When you join Singota, you are a part of a team that respects, supports, and values its people. We celebrate wins together, brainstorm solutions together, and genuinely enjoy the work we do. The result? A team that’s not just efficient, but also passionate, dedicated, and fun to work with.

Job Title: Regulatory Affairs Specialist

Department: QA/RA

Reports to: Sr. Regulatory Affairs Specialist

Location: Bloomington, IN (Hybrid)

Position Type: Full-time, Exempt, 40 hr/wk

General Description:

The Regulatory Affairs Specialist assists in the support and execution of regulatory affairs and compliance programs at Singota. This role will be responsible for supporting day-to-day regulatory operations, including providing regulatory guidance and support to Singota’s diverse client base. The Regulatory Affairs Specialist will support the organization by providing CMC regulatory support, preparing and managing regulatory documentation, and coordinating with internal and external technical teams and stakeholders to ensure compliance with applicable regulatory standards and guidance. The role also includes supporting the implementation and maintenance of procedures to verify that the regulatory program remains effective and efficient. This is a remote position; however, routine onsite presence will be required as needed to support audit activities and other business requirements.

Key Responsibilities:

1. Conduct ongoing regulatory surveillance to proactively identify and address upcoming regulatory changes and collaborate with relevant departments to identify and implement necessary changes.

2. Assist in the management of Singota licensing, certifications, and registrations, including but not limited to domestic and foreign agencies, regulatory bodies, and government agencies.

3. Assist in commercial/controlled substance license evaluations of Singota’s supply chain partners to ensure compliance with Drug Supply Chain Security Act (DSCSA) requirements.

4. Support internal compliance with applicable regulatory requirements (e.g., FDA, MHRA, EMA, ICH, etc.)

5. Collaborate with internal departments in addressing regulatory topics and provide guidance as needed.

6. Assist with impact assessments for manufacturing, analytical, facility, and supplier change notifications.

7. Interface with clients during routine project meetings to provide regulatory guidance and support.

8. Coordinate information requests between Client(s) and internal technical functions.

9. Provide support during client and regulatory audits of Singota, ensuring regulatory and quality standards are met.

10. Provide support in preparation of client regulatory submission documentation, as applicable, including but not limited to Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Biologics License Applications (BLAs) in accordance with regulatory requirements.

11. Provide support in preparation and submission of facility Drug Master File (DMF), as well as annual product review(s) (APRs), and annual reporting requirements.

12. Author and review site procedures and specifications to verify adherence to applicable regulations.

13. Design and deliver training sessions and refresher courses to communicate regulatory changes to key stakeholders across the organization.

14. Assist with compilation, formatting, and quality verification of regulatory submissions to ensure accuracy and completeness.

15. Assist in the development and management of audit responses, working collaboratively across functions and ensuring accurate documentation and management of all audit records.

16. Participate in the preparation, evaluation, and modification of client Quality Agreements

17. Provide primary ownership of deviations, CAPAs and change controls as needed.

18. Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes, and procedures.

19. Contribute to the assessment of business opportunities by evaluating potential projects from a regulatory standpoint as part of a cross-functional team.

20. General support required of a company where everyone is expected to perform multiple tasks both inside and outside their department to meet the needs of the business.

Skills and Physical Activity Requirements:

1. Must possess excellent written and oral skills.

2. Demonstrate a positive attitude and professional presence within the workplace and when interacting with external parties

3. Must possess strong organizational skills with the ability to manage competing priorities across multiple client programs.

4. Individual must have a strong attention to detail for review and interpretation of quality and regulatory documentation/submissions.

5. Ability to follow established standard operating procedures and established processes; escalating issues appropriately.

Education and Work Experience Requirements:

1. Bachelor’s degree or equivalent experience – science or regulatory related field preferred.

2. Minimum 3-5 years pharmaceutical experience is required, preferably in a quality/regulatory role.

3. Experience with regulatory submissions/regulatory surveillance is desired.

4. Proficiency in Microsoft Office; familiarity with document management system(s) and eQMS platforms is desired

Benefits:

Dental insurance - effective day one of employment

Health insurance - effective day one of employment

Vision insurance - effective day one of employment

Health savings account

Life & AD&D insurance

Short & long term disability

Paid time off & holidays

Employee Assistance Program

Tuition assistance

401(k) with company match

Singota Solutions is an Equal Opportunity Employer

Job Type: Full-time

Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Employee discount
Health insurance
Health savings account
Life insurance
Paid time off
Tuition reimbursement
Vision insurance

Experience:

life sciences: 3 years (Required)

Ability to Commute:

Bloomington, IN 47404 (Required)

Work Location: Hybrid remote in Bloomington, IN 47404

Apply Now

Refine Your Search

quality management system jobs in bloomington in

Regulatory Affairs Specialist

SDS Author (Remote)

QUALITY ASSURANCE TESTER II

Work Management Specialist I or II

IT User Support Technician

Retail Customer Service Associate

Logistics supervisor

Online Grocery Pick-Up Clerk

Billing Analyst - Hybrid Remote

Production Operator

Exam Coordinator (Educational Resources Coordinator), Accessible Educational Service

Office Manager- Urology

Assistant Director of Academic Advising (Academic Advisor)

Contracts and Grants Specialist

Academic Advisor

Outside Recovery Associate

System Administrator

Financial Administration Specialist

Associate Director (Program Management Specialist)

Cashier

I want to receive the latest job alert for quality management system in bloomington in

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