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Title: Administrative Support, Quality Assurance

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

• Duration: 6 mos, possibility to extend
• Pay rate: $28-35/hr
• Job Location: Boston MA
• Job#: bh14220

Administrative Support, Quality Assurance

General Position Summary: Provides temporary administrative support for Quality Assurance processes as defined under Key Responsibilities below.

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Creates Certificate of Analysis and Release data files within the electronic document management system (EDMS) and coordinates review with Quality representative
• Performs Archival of QA Records in EDMS (e.g., CMO batch records, data packages)
• Conduct follow up on Action Items for Quality Leadership Team (QLT) meetings
• Assist with quarterly updates for Continuous Improvement Projects and Risk Trackers
• Assist with generation of Metrics and Metrics reports
• Performs Data Entry into GxP Regulated Systems as required
• Manages events/CAPAs in electronic quality management system (EQMS), including data entry, tracking, and follow-ups with Owners to drive completion
• Coordinates document approval and creates Docusign workflows, as necessary
• Schedules and coordinates meetings for CMC Quality Operational team (Leadership meetings, Extend group meetings).  Manages agenda and minutes and follows up on all action items

Minimum Qualifications:

• Bachelor’s degree and 0 – 3 years of relevant work experience in the Biotech or Pharmaceutical industry, or relevant comparable background

Preferred Qualifications:

• Adaptability/flexibility
• Strong written and verbal communication skills
• Attention to detail
• Organizational/planning and coordination skills

Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.

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