Connexion Systems & Engineering, Inc. is hiring: QC Data Reviewer in Norwood

Job Title: Quality Control Data Reviewer
Location: Norwood MA
Comp: $50-60/hr
Shift: MON - FRI, 11AM - 7PM

 

The Role
In this role, you will support QC Bioassay Labs with review of test records and documents.
This is an on-site position. The shift is Monday to Friday, 11 am to 7pm.
Here’s What You’ll Do

• Review executed QC test records for molecular and cell-based assays
• Review Audit trails
• Review reagent and equipment logbooks
• Follow 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 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