Notes:

Hybrid role- Minimum 50% onsite and some activities can be done remote and other activities must be done onsite

Contractor must be able to come onsite when needed

Work Schedule- Monday through Friday - 1st shift

Job Description/ Responsibilities:

• Strong background in Validation, Engineering, QA Computer System Engineer, or QA Engineering.
• Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions.
• Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations
• Reviews and approves Quality, Quality Control, Validation and Automation related documents
• Review and approves Standard Operating Procedures (SOPs).
• Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reports.
• Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements.
• Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.
• Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working environment
• Able to interpret complicated data and make sound decisions, Independently
• Preferred some cell banking or project management experience.
• Preferred AIQ (Analytical Instruments qualification)/ Quality Control(QC) qualification experience

This position will regularly interact with:

• Reporting Senior Manager

Sometimes will interact with departments listed below:

• Quality Control
• Manufacturing Operations
• Manufacturing Engineering
• Manufacturing Science and Technology (MS&T)
• Validation
• Site Engineering
• Digital Plant

Qualifications:

• Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
• Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic or paper based batch records desirable.
• Excellent Technical writing and oral communication skills are required.
• Background in problem solving

Job Type: Contract

Salary: $48.26 - $62.00 per hour

Benefits:

• Health insurance

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Devens, MA 01434: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Validation engineer: 3 years (Preferred)
• US and EU cGMP regulations: 3 years (Preferred)
• CAPA: 3 years (Preferred)
• SAP, LIMS, TrackWise, Veeva Vault: 2 years (Preferred)
• pharma industry: 3 years (Preferred)

Work Location: One location

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