Bioassay Data Reviewer

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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