Job Description

Job Description

Job Description

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

Connexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

Company Description

Connexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

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