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QC Equipment Specialist Jobs in Norwood, Massachusetts, USA at Mastech Digital
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QA Validation Consultant
Location:
Norwood, MA
Long term Contract
Job description of the role:
Responsible for managing the Quality review/approval of design and commissioning documentation, validation protocols (including associated discrepancies), reports and/or support records to ensure compliance with industry standards and regulations as well as internal specifications and procedures; ensures timely resolution of documentation, compliance, and quality system issues
Support review and approval of validation lifecycle documentation; including but not limited to: IA, URS, DQ, ERES, CDS/FRS, FMECA, IOQ
Reviews and assists in investigating discrepancies/deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments
Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method, and computer system validation
Participates in cross functional meetings for planning and discussing changes to be commissioned, qualified, validated equipment/facilities/utilities
Participates in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs
Use critical thinking skills to partner with CQV and facility engineers to problem solve
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.
Seniority level:
Mid-Senior level
Employment type:
Full-time
Industries:
Engineering Services and Pharmaceutical Manufacturing
Thanks
Ritika Aithmian
#J-18808-Ljbffr
Title: QC Equipment Specialist
Company: Mastech Digital
Location: Norwood, Massachusetts, USA
Category: Quality Assurance – QA/QC (Quality Engineering)
