quality assurance specialist - gmp - hybrid.

• norwood , massachusetts

• posted may 9, 2024

job details

summary

• $55 - $56 per hour

• temporary

• bachelor degree

• category life, physical, and social science occupations

• referenceAB_4531458

job details

The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug products produced at this facility. He/she will provide quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight or manufacturing experience in early stage clinical products. They will be able to interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Manufacturing, Logistical and Process Development Technology Transfer counterparts. Here's What You'll Need:

• 3+ years of experience in a GMP Manufacturing environment, focused on Quality Assurance

• Bachelor's degree in a science related field

• Experience with Raw Material Batch record review (DNA and lipids) preferred

This role is 95% remote, with on-site requirements quarterly and as needed for audits

salary: $55 - $56 per hour

shift: First

work hours: 8 AM - 4 PM

education: Bachelors

Responsibilities

• Conduct thorough review of Master Batch Records (MBR) and electronic Batch Records (eBR), collaborating closely with the manufacturing team to ensure timely finalization of documentation.

• Perform quality inspections of logbooks that are pending review to ensure compliance and completeness.

• Provide quality supervision during the implementation of corrective actions and preventive actions (CAPA) and verify the effectiveness of these actions to sustain production continuity or advance processes to subsequent phases.

• Oversee the resolution of quality documentation, including deviations, change controls, CAPAs, Process Improvements (PI), and Engineering Changes (EC), prioritizing collaboration with interdisciplinary teams to expedite the completion of these records, addressing them in order of receipt or as per the backlog.

• Review and certify scanned copies of GMP documents submitted for archive.

• Additional duties as may be assigned as needed

Skills

• Quality Assurance (2 years of experience is required)

• GMP

• CAPA

• Process Improvement

• Batch Record Review

• SAP

• Veeva

• CMO Review

• DNA

• lipids

Qualifications

• Years of experience: 3 years

• Experience level: Experienced

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Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

Applications accepted on ongoing basis until filled.

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SD

samantha dougherty

• sam.dougherty@randstadusa.com