Job Title: Bioassay Data Reviewer
Contract Duration: 6 Months
Pay range: $60 - 65/hr
Location: Norwood, MA
Work Type: 100% Onsite, Monday - Friday 11 am to 7 pm.

Job Description:
In this role, the Bioassay Data Reviewer will support QC Bioassay Labs with a review of test records and documents.

Job Responsibilities:
Review executed QC test records for molecular and cell-based assays
Review Audit trails
Review reagent and equipment logbooks
Bioassay Data Reviewer follows all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
Complete training in the assigned required learning plan according to the defined timing and the prescribed requalification cadence.
Additional duties may be assigned.

Here's What You'll Need ( Basic Qualifications):
Education: BA /BS Degree
Experience: STEM degree with 5+ years of experience in a cGMP laboratory setting, with hands-on experience in molecular biology and cell-based assays (e.g. qPCR, sequencing, potency, mammalian, and bacterial cell culture)
Specific Certifications or Training: None

Here's What You'll Bring to the Table (Preferred Qualifications):
Excellent communication skills (verbal and written)
Working knowledge of USP, ISO, FDA, and ICH guidelines
Experience with laboratory information systems
Demonstrated ability to work effectively under established guidelines and instructions
Ability to collaborate effectively in a dynamic, cross-functional matrix environment
Working knowledge of Data Integrity principles and Good Documentation Practices
Previous experience reviewing data in GMP environment for GDP/GMP compliance as well as audit trail review
Previous experience using Labvantage LIMS and LES worksheets

Benefits:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund

About the Company:
mRNA therapeutics company developing innovative drugs for various diseases. Offers expertise in prophylactic vaccines, therapeutic vaccines, immuno-oncology, localized therapeutics, and liver intracellular therapies. Join our team and make a difference in the future of medicine.

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