Quality & Monitoring Coordinator

Worcester, MA
Full Time
Biomere
Experienced
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:
  • Responsible for supporting preclinical GLP projects 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’s or Bachelor’s degree in Science (or equivalent) preferred.
  • 2 years of experience in preclinical (auditing preferred)

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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