QA lead technical operations
Spectraforce
Devens, Massachusetts
a year ago
Job Description
Position: QA Lead Technical Operations, Projects
Location: Onsite, Devens, MA, 01434
Duration: 6 Months
Work Schedule: Mon - Fri, First shift (8:30 AM - 5 PM)
Contractor must be able to come onsite Monday through Friday - 1st shift
Job Description/ Responsibilities:
• Provides Quality Assurance (QA) support to Devens Site and reporting Manager 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 approve Standard Operating Procedures (SOPs).
• Review and approval of Validation-related documentation such as risk assessments, protocols 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
assessment, 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
This position will regularly interact with the following:
Reporting Manager
Sometimes will interact with the departments listed below:
Quality Control
Manufacturing Operations
Manufacturing Engineering
Manufacturing Science and Technology (MS&T)
Validation
Site Engineering
Digital Plant
Education, Experience, and Qualifications:
• Knowledge of science generally attained through studies resulting in a B.S.; in Biological science, Engineering,
biochemistry, or related discipline, or its equivalent is preferred.
• Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product
quality. Preferred Active member of ASQ or ISPE.
• Prior experience of QC equipment Qualification and some project management experience
• Knowledge of biotech, bulk drug substance or finished product manufacturing, and medical device analytical testing is
highly desirable.
• Extensive knowledge of US and EU cGMP regulations, 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
• Knowledge of Data integrity principles
• Proven attention to details
• Comfortable working in an FDA-regulated environment.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 62.00/hr.
Location: Onsite, Devens, MA, 01434
Duration: 6 Months
Work Schedule: Mon - Fri, First shift (8:30 AM - 5 PM)
Contractor must be able to come onsite Monday through Friday - 1st shift
Job Description/ Responsibilities:
• Provides Quality Assurance (QA) support to Devens Site and reporting Manager 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 approve Standard Operating Procedures (SOPs).
• Review and approval of Validation-related documentation such as risk assessments, protocols 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
assessment, 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
This position will regularly interact with the following:
Reporting Manager
Sometimes will interact with the departments listed below:
Quality Control
Manufacturing Operations
Manufacturing Engineering
Manufacturing Science and Technology (MS&T)
Validation
Site Engineering
Digital Plant
Education, Experience, and Qualifications:
• Knowledge of science generally attained through studies resulting in a B.S.; in Biological science, Engineering,
biochemistry, or related discipline, or its equivalent is preferred.
• Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product
quality. Preferred Active member of ASQ or ISPE.
• Prior experience of QC equipment Qualification and some project management experience
• Knowledge of biotech, bulk drug substance or finished product manufacturing, and medical device analytical testing is
highly desirable.
• Extensive knowledge of US and EU cGMP regulations, 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
• Knowledge of Data integrity principles
• Proven attention to details
• Comfortable working in an FDA-regulated environment.
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 62.00/hr.