Top 16122 Coordinator Regulatory Programs Jobs

Stability Coordinator I
Norwich Pharmaceuticals Inc —Norwich, NY
- $62,354 a year
- Full-time
- Computer literacy
- Organizational skills
- 1 year
- Wellness program
- Health savings account
Quick Apply
Quality, Regulatory & HazMat Training Manager
Tanner Industries, Inc —Southampton, PA
- Full-time
- Up to 50% travel
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
Community Clinical Program Director (aka Director of Clinical Community Programs)
The Hume Center —Concord, CA
- $129,000 - $160,000 a year
- Weekends as needed
- Background check
- Spanish
- Addiction Medicine
- Mileage reimbursement
- Paid holidays
Quick Apply
13d
Quality Improvement and Risk Management Coordinator
Brightwell Behavioral Health —Garden City, MI
- Full-time
- Nursing
- RN License
- Inpatient
- Health insurance
- Dental insurance
Quick Apply
HR Learning and Development Coordinator
Tageos —Fletcher, NC
- Up to $72,000 a year
- Full-time
- Mid-level
- Bachelor's degree
- Continuous improvement
- Health savings account
- Health insurance
Quick Apply
Executive Director
Sitka Sound Science Center —Sitka, AK
- $117,000 - $165,000 a year
- Full-time
- Background check
- Driver's License
- Presentation skills
- Health insurance
- Dental insurance
Quick Apply
Defense Fuels Program Manager
EX FIS US, INC —Durham, NH
- $40,000 - $50,000 a year
- Full-time
- Military
- Office
- Project management
Quick Apply
MDS Coordinator (RN or LPN)
Leisure Village Health Care Center —Tulsa, OK
- Full-time
- CPR Certification
- Nursing
- Skilled nursing facility
- Dental insurance
- 401(k)
Quick Apply
12d
Child Psychiatrist
Interborough Developmental and Consultation Center —Brooklyn, NY
- $350,000 - $375,000 a year
- Full-time
- Bilingual
- Background check
- Medicine
- Profit sharing
- Health savings account
Quick Apply
Special Education Coordinator
Uncommon New York City Charter Schools —New York, NY
- $77,000 - $120,000 a year
- Full-time
- Classroom
- Mid-level
- 403(b) matching
- Health savings account
Quick Apply
Health Sciences Distance Site Coordinator
Great Falls College Montana State University —Bozeman, MT
- $22.00 - $23.25 an hour
- Full-time
- Customer service
- Computer literacy
- Clinic experience
- Relocation assistance
Quick Apply
12d
MDS Coordinator
Brewster Village —Appleton, WI
- $75,566 - $85,051 a year
- Full-time
- Background check
- CPR Certification
- Nursing
- Health savings account
- Disability insurance
Quick Apply
Elem. Director of Special Education Services - 5+ yrs Experience in that Role Req.
CARDINAL MCCLOSKEY COMMUNITY CHARTER SCHOOL —Bronx, NY
- From $70,000 a year
- Full-time
- Bilingual
- School experience
- 5 years
- Health savings account
- Health insurance
Quick Apply
Clinical Education Coordinator - Diagnostic Medical Sonography
Monroe University —Bronx, NY
- $80,000 - $90,000 a year
- Full-time
- Writing skills
- Clinic experience
- Mid-level
- Health savings account
- Health insurance
Quick Apply
EMS Operations Coordinator
El Dorado County Emergency Services Authority —Diamond Springs, CA
- $62,500 - $85,500 a year
- Full-time
- Background check
- Mid-level
- Driver's License
- Paid holidays
- Health insurance
Quick Apply
8d
Registered Nurse Assessment Coordinator (RNAC / MDS Coordinator)
Country Lane Manor —Keosauqua, IA
- $40 - $45 an hour
- Weekends as needed
- Skilled nursing facility
- RN License
- Mid-level
- Commuter assistance
- Disability insurance
Quick Apply
Safety Coordinator
Norton Transport —Ringgold, GA
- $33,000 - $40,000 a year
- Full-time
- Writing skills
- Research
- Mid-level
- Health savings account
- Health insurance
Quick Apply
Safety and Health Coordinator
Western Sugar Cooperative —Scottsbluff, NE
- $60,000 - $72,000 a year
- Full-time
- Background check
- Spanish
- Microsoft Outlook
- Relocation assistance
- Health insurance
Quick Apply
Community Living Team Coordinator
Horizons Specialized Services —Steamboat Springs, CO
- $25.35 an hour
- Full-time
- Background check
- 18 years or older
- CPR Certification
- Health insurance
- Dental insurance
Quick Apply
BHH Coordinator - Children's Case Management
Woodfords Family Services —Manchester, ME
- $45,000 - $47,000 a year
- Full-time
- Hybrid work
- Experience working with individuals with developmental disabilities
- Mid-level
- Office
- Wellness program
- Paid holidays

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Stability Coordinator I

Norwich Pharmaceuticals Inc -
Norwich, NY

Quick Apply

Job Details

Full-time
$62,354 a year

Benefits

Wellness program
Health savings account
Paid holidays
Disability insurance
Health insurance
Dental insurance
Flexible spending account
Paid time off
Vision insurance
Life insurance
Prescription drug insurance

Qualifications

Computer operation
Customer communication
Laboratory standard operating procedures
Desktop applications
Productivity software
Standard operating procedures (SOPs)

Full Job Description

SUMMARY OF POSITION

The Stability Coordinator I is responsible for all aspects of the stability sample program. The Stability Coordinator initiates and manages stability studies, including protocol development and maintenance, sample handling, and data reporting.

ORGANIZATION STRUCTURE

The Stability Coordinator I reports to a QC Manager or Team Leader.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

1. Master Stability Protocol Management

a. Create and maintain Master Stability Protocols based on the registered requirements and in compliance with all current ICH/FDA regulatory guidance.

b. Work directly with project team to define stability commitments for study design, testing requirements, and material specification references.

c. Calculate the number of samples required per study based on pack types and storage conditions.

d. Review specification changes for products to assess impact to Master Stability Protocols and revise protocols as needed using appropriate change management systems.

2. Study Protocol Management

a. Create, review, and/or approve stability study protocols and summary report tables.

b. Submit sample request forms to be included with the production records for individual stability studies.

c. Assign stability study identification numbers and stability sample quantities to individual study protocols.

d. Ensure stability samples are labeled properly and placed in the correct conditioned chamber(s) for storage.

e. Revise stability study protocols as needed throughout study lifetime.

3. Study Scheduling and Implementation

a. Perform stability study sample pulls according to daily pull schedule.

b. Review and ensure the correct samples are pulled and delivered to the appropriate NPI laboratory when due.

c. Provide stability data to customers when applicable.

d. Dispose of stability samples when study is completed or discontinued.

e. Work with metrology department on chamber monitoring and maintenance.

f. Participate in stability improvement projects.

4. Compliance Activities

a. Complete corrective and preventive actions when assigned.

b. Prepare stability data tables and summary reports as needed for customer Annual Reports or ongoing regulatory and/or stability data review processes.

c. Review stability summary data tables for compliance and possible trends. Ensure any stability issues or potential issues are appropriately communicated to laboratory management.

5. Additional duties as required

QUALIFICATIONS

1. A degree in life sciences, plus 1-3 years of pharmaceutical experience, or equivalent combination of education and experience.

2. Excellent oral and written communication skills.

3. Proficient in computer use (Word, Excel, PowerPoint, internet) with ability to learn new computer applications.

4. Ability to comprehend and follow standard operating procedures and test methods.

5. Strong attention to detail and ability to multitask.

6. Operates with a sense of urgency in a fast-paced environment.

7. Strong organization, communication, and interpersonal skills.

GMP DECISION-MAKING AUTHORITY

1. Authors regulatory documents and reports.

2. Authors and revises stability protocols.

3. Maintains and implements stability sample pull schedule.

4. Reviews and reports stability data.

5. Participate in audits as required.

The anticipated base salary for this position is $62,354.00. This position is eligible for Alvogen’s annual discretionary bonus and comprehensive benefits package, consisting of medical and prescription drug coverage (two PPO plans and an HDHP with Health Savings Account and employer contribution), dental, vision, flexible spending accounts. Alvogen’s benefits package also includes a retirement savings program, long-term care coverage, paid time off (176 hours per year, prorated to hire date) inclusive of sick time, disability benefits, life insurance, a wellness program, and 13 company recognized paid holidays per year. We anticipate this position will be posted on [Posting Date] and remain open for at least 20 days. To apply, select the apply button and submit your application.

An Equal Opportunity Employer, including disability/vets

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Refine Your Search

Coordinator Regulatory Programs jobs

Stability Coordinator I

Quality, Regulatory & HazMat Training Manager

Community Clinical Program Director (aka Director of Clinical Community Programs)

Quality Improvement and Risk Management Coordinator

HR Learning and Development Coordinator

Executive Director

Defense Fuels Program Manager

MDS Coordinator (RN or LPN)

Child Psychiatrist

Special Education Coordinator

Health Sciences Distance Site Coordinator

MDS Coordinator

Elem. Director of Special Education Services - 5+ yrs Experience in that Role Req.

Clinical Education Coordinator - Diagnostic Medical Sonography

EMS Operations Coordinator

Registered Nurse Assessment Coordinator (RNAC / MDS Coordinator)

Safety Coordinator

Safety and Health Coordinator

Community Living Team Coordinator

BHH Coordinator - Children's Case Management

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