Company: Confidential
Job Title: Senior Specialist, CMC Quality Assurance Contractor
Job Number: 87233
Location: 100 Cambridgepark Dr Cambridge, US
Job Description
Vor Bio is seeking a Senior Specialist, CMC Quality Assurance Contractor who will be responsible for providing onsite Quality support for CMC Operations at Vor’s internal manufacturing facility in Cambridge, MA. The successful candidate will engage with and support batch record review, manage deviations and other quality system records, and provide on-the-floor Quality Assurance support.
Responsibilities
Key areas of responsibilities: * Responsible for clinical batch record review, and quality oversight of CMC operations. Review batch records, deviations, and other quality events as applicable to determine acceptability of product disposition * Responsible for QA oversight of raw material receipt and release * Responsible for onsite QA support for supply chain * Responsible for onsite QA support for manufacturing (must be willing to work in a cleanroom environment and pass gowning qualifications for ISO 7 areas) * Review and approval of product and materials stability records * Review and approval of logbooks and other on-the-floor documentations * Provide on-the-floor QA support as needed
Required Skills
Skills and requirements: * BA/BS and a minimum of 5-7 years’ experience in a Quality Assurance position within a GMP environment. * Experience with cell and gene therapy products preferred * Strong knowledge of GMP regulations and quality systems * Must be able to work collaboratively with cross-functional groups to ensure compliance and adherence to regulations and established procedures. * Should be highly motivated, flexible, and have excellent organizational and communication skills. * Must be able to work both independently and as part of a multi-disciplinary team * Must be able to work onsite at our Cambridge MA facility on a regular basis * Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines * Experience in managing relationships with internal departments and external vendors in a collaborative, constructive manner
Application Deadline: 2024-12-02
To apply for this job please visit jobrxiv.org.