Quality Monitoring Coordinator
Quality Monitoring Coordinator
Posted on :
11-04-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
11-04-2025
Job Description
Job Summary:
The Quality and Monitoring Coordinator (QM) is responsible for supporting compliance with quality system procedures and all applicable Federal State Local International and Industry regulations in addition to company training policies guidelines and standard operating procedures.
Responsibilities:
Education and Experience Requirements:
Skill Requirements:
BENEFITS
The Quality and Monitoring Coordinator (QM) is responsible for supporting compliance with quality system procedures and all applicable Federal State Local International and Industry regulations in addition to company training policies guidelines and standard operating procedures.
Responsibilities:
- Responsible for supporting compliance with all applicable regulations (Local State Federal International FDA and other applicable agencies).
- Responsible for supporting Quality Management System processes and procedures including Document Control Internal Auditing Quality Management Review and CAPA plans.
- Participate in the preparation and review of study and applicable QA files in preparation for sponsor site visits and regulatory inspections; assure that QA audit files are retained.
- Support regulatory inspections accreditations and client qualification audits.
- Cohost/represent the company at regulatory inspections.
- Provides support to Quality and Compliance by writing editing or reviewing responses and submissions of preaudit questionnaires audit response documents and corrective action implementation and/or response.
- May be responsible for coordinating authoring and revising controlled documents including but not limited to; company policies guidelines and SOPs.
- May represent the company at client inspections and study monitoring events.
- In collaboration with the Quality Team conducts periodic studybased audits to ensure compliance with regulatory requirements internal policies and procedures.
- Partner with scientists and the Quality Team to support the review of study data and review study reports for compliance against standard operating procedures protocols and GLP/GCLP regulations (as applicable).
- Interact professionally with company management senior staff and third parties as required to provide effective compliance management and guidance.
- May be responsible to Identify the required initial and continuing training for quality systems and compliance and ensures all employees are trained on appropriate curricula.
- Partners with the QAU consultant to schedule and provide GLP training to applicable personnel.
- Collaborates with Organizational Development/Training Development (OD/TD) Team to ensure employee training programs are compliant with all regulatory requirements.
- Complies with all regulatory guidelines occupational health as well as health and safety programs in accordance with company policies and procedures.
- Performs all other duties as required.
Education and Experience Requirements:
- Required: Associatesor Bachelors degree in Science (or equivalent) preferred.
- Greater than 2 years of experience
Skill Requirements:
- Functions independently with guidance from the head of QD and the head of QAC.
- Improves company quality assurance and compliance program in collaboration with senior staff.
- Edits and/or creates company policies guidelines and SOPs in collaboration with senior staff.
- Edits and/or creates training on QA Quality Systems and regulatory policies in collaboration with the head of Training.
BENEFITS
- Medical Dental and Vision Insurance Biomere pays substantial portion of premium
- Health Reimbursement Arrangement (HRA) automatic reimbursement of any spending toward first half of deductible
- Flexible Spending Accounts Medical and Dependent Care
- ShortTerm and LongTerm Disability Life Insurance AD&D premiums paid by Biomere
- Vacation Holidays Sick/Personal Days
- 401K Plan with 5 matching
- Referral Bonus Program & Certification Bonuses
- Free parking
No agencies please.
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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