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.
- Co-host/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 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,
- 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: Associate’s or Bachelor’s 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
- 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
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What We Do
Biomere is a global, nonclinical contract research organization (CRO) with locations on the east and west coast, as well as multiple locations in China (JOINN). Our globality, personal approach and our drive to expedite research timelines, makes us ideally suited to support our clients’ needs. Visit the “CRO Expertise” area of our website at Biomere.com to review our capabilities and resources. Our Facilities are AALAC accredited, OLAW Assured, DEA Licensed, and USDA Registered. JOINN is a pioneer in commercial GLP services and is a leading CRO in China, with facilities in Suzhou, Beijing, Wuzhou and Chongqing. The following differentiators set us apart from many other CROs: • Competitive study-start timing • Largest colony of NHPs available in New England • Enhanced and rapidly growing ocular research program (U.S. and China) • East coast vivarium and headquarters near Boston (Worcester, MA) • New west coast vivarium (San Francisco North Bay area) • Dedicated concierge team skilled in navigating studies placed in China • China concierge team member with over 10 years USDA experience • 20 - 30% savings on studies placed in China At Biomere, It's Personal. Our relationships with our clients are what sets us apart. We are truly driven to expedite your research journey. Make sure to visit The Concourse, our private life science sharing community on our website to take advantage of the resources created for you by KOLs in the life science community. Visit soon! Visit Often! resources are added frequently.
