GLP Quality Assurance Lead
GLP Quality Assurance Lead
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The QA Lead 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 providing quality oversight and compliance verification for GLP requirements across GLP studies.
- 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.
- Participate as GLP QA expert on GLP studies at facility audits.
- Cohost/represent the company at regulatory inspections client inspections and study monitoring events.
- Provide 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
- Collaborate with senior staff to implement inspection and audit readiness activities.
- 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.
- 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: Associates or Bachelors degree in Science (or equivalent) preferred.
- Certifications preferred: ASQ GLP
- 5 years of experience within preclinical GLP Quality Assurance
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 senior staff.
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
Required Experience:
Senior IC
Employment Type
Full-Time
