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
Co-host/represent the company at regulatory inspections
Provides support to Quality and Compliance by writing, editing, or reviewing responses and submissions of pre-audit 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 study-based 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: Associate’sor Bachelor’s 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
Short-Term and Long-Term 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.
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Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Internet Publishing
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