Job Number: 20-00578
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Associate for our client in Andover, MA.
Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- This Quality position is an Andover based position which reports into PharmSci QA responsible for supporting the Pharmaceutical Sciences Organization.
- The candidate works primarily in support of clinical manufacturing operations.
- This position requires strong collaboration skills with a focus on procedures, documentation, inspections, continuous improvement and compliance effectiveness.
- The Colleague will perform a range of duties associated with the management of documentation, procedures, manufacturing operation support (batch record review) to ensure consistency and compliance with regulatory expectations and company standards.
- Support day to day clinical manufacturing operations from a Quality support perspective (batch record review)
- Performs procedural activities within the Global Documentation Management System
- Partners with SOP authors to develop procedures and appropriate implementation plans for the management of physical and electronic documents
- Reviews SOPs, determines gaps and provides input to as it relates to documentation management
- Role is primarily office-sitting, standing, walking, and bending. This may be inclusive of leading/participating in Webex
- Experience in biologics and or Quality Assurance
- Team player with strong interpersonal, organizational, documentation and communications skills
- Mental agility to handle a broad scope of different types of quality assurance work (e.g. reviewing documentation focus, communication 1:1 and with larger groups)
- BA or BS
- MS with 1 year of experience
- QA support
- 1 year of GMP experience (internship, fresh grad, etc.)
- 1-3 years of experience in general support, SOP and batch record review
- BS Science degree
- Pharma industry experience (1-3 years)
- Knowledge of GMP and regulatory requirements as related to the drug development process
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Jay Lucas | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.