Senior Quality Assurance Validation Contractor

The Steely Group

Bedford, MA
30+ days ago

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Skills

Automationunmatched
Biochemistryunmatched
Biotech and Pharmaceuticalunmatched
Cell Culturesunmatched
Chemistryunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Cross-Functionalunmatched
Data Analysisunmatched
Data Qualityunmatched
Detail Orientedunmatched
Documentation Reviewunmatched
Equipment Validationunmatched
FDA Requirementsunmatched
GMP (Good Manufacturing Practices)unmatched
Microbiologyunmatched
On Site Supportunmatched
Organizational Skillsunmatched
Presentation/Verbal Skillsunmatched
Process Validationunmatched
Quality Assuranceunmatched
Risk Analysisunmatched
System Lifecycleunmatched
System Validationunmatched
Systems Analysisunmatched
Technical Writingunmatched
Validation Documentationunmatched
Writing Skillsunmatched

Description

The Senior Quality Assurance Validation Contractor position is ab onsite contract position at the facility located in Bedford, MA to provide support primarily for project related work.

Responsibilities:

Provide onsite QAV support at the facility located in Bedford, MA to support the following QAV activities for the tech transfer project:
Review and approval of equipment, automation, facility, and utility system validation lifecycle documents for the tech transfer project including but not limited to:
SLRA (System Level Risk Assessments)
DI (Data Integrity) Assessments
DR/DQ
Specifications
IQ/OQ/PQ Qualification Protocols
Validation Issues
IQ/OQ/PQ Qualification Reports
Risk assessments
Review and approval of BMRAM work orders for equipment, automation, facilities, and utilities.
Independently represent QAV in cross functional project meetings.

Requirements / Qualifications:

A B.S. degree in Engineering or other Science field such as microbiology, chemistry or biochemistry.
Experience in biopharmaceutical or biotechnology based GMP operations with experience in Quality and/or Validation roles.
Direct experience with facility, equipment, and utility validation is required.
Experience with cell culture and single use systems is preferred.
Knowledge of relevant FDA and EMA regulations.
Ability and willingness to work in a fast-paced environment that will require a combination of individual contribution documentation reviews and communication of quality requirements aligned with program procedures in cross functional meetings.
Excellent oral and written communication skills with strong technical writing experience is required.
Excellent organizational skills and attention to detail.
Experience with continuous improvement efforts.

Numbers & Facts

Location

Bedford, MA

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