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QA Specialist
Ref No.: 17-02751
Location: Woburn, Massachusetts
Position Type:Contract
Start Date / End Date: 09/18/2017 to 09/17/2018
In this role this candidate would be handling all validations- Ideal candidate would have science or engineering experience/degree with at least 8 years' experience in validation investigation within the Biopharma space. M-F onsite

• As a main priority, perform review, approval and tracking of cGMP validation documentation and including but not limited to Nonconformance, CAPAs, Change Control records
• Supports development and ensure adherence to projects timelines
• Ensures that deviations from established procedures are investigated and

• documented per procedures
• Ensures that documentation are complete, accurate, and documented according to written procedures and cGMP requirements
• Collaborates cross functionally and provides validation/technical input as needed
• Alerts of quality, compliance, supply and safety risks
• Completes required assigned training to permit execution of required tasks
• Performs additional duties as specified by management

Basic Qualifications
• Bachelor degree in a science or engineering discipline
• No less than 5 years of experience in the pharmaceutical environment and validation
• Knowledge in cGMP manufacturing and technical knowledge in validation of pharmaceutical processes/systems/equipment
• Project Management and organizational skills, including ability to follow assignments through to completion

Top 3 Must Have Skill Sets:
  1. Validation 2. Technical writing 3. Computer literate (Microsoft office)

Day to Day Responsibilities:
As a main priority, perform review, approval and tracking of cGMP validation documentation and including but not limited to Nonconformance, CAPAs, Change Control records • Supports development and ensure adherence to projects timelines • Ensures that deviations from established procedures are investigated and • documented per procedures • Ensures that documentation are complete, accurate, and documented according to written procedures and cGMP requirements • Collaborates cross functionally and provides validation/technical input as needed • Alerts of quality, compliance, supply and safety risks • Completes required assigned training to permit execution of required tasks

Employee Value Proposition:

Gain experience in competitive well known company. Will be part of a technical group and gain more skills and will expand current networks.