QA Lead Technical Operations

Katalyst CRO; Harvard (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading CRO is seeking a seasoned Quality Assurance Specialist to oversee QA support and documentation approval processes at their Harvard site. This role requires extensive experience in GMP environments, strong problem-solving skills, and a solid foundation in regulatory expectations, offering the opportunity to work in a dynamic and regulated setting.

Qualifications

• 8+ years of experience in GMP, GCP or GXP focused on product quality.
• Excellent technical writing and oral communication skills.
• Extensive knowledge of US and EU cGMP regulations.

Responsibilities

• Provide QA support through approval of Investigations and Corrective Actions.
• Review and approve Quality Control, Validation and SOP documentation.
• Coach across departments in Investigations and CAPAs.

Skills

Quality Assurance

Technical writing

Problem solving

Data integrity principles

Education

B.S. in biological science, Engineering, or biochemistry

Tools

SAP

LIMS

Track Wise

Veeva Vault

Job description

Responsibilities

• 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 approve 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.
• This position will regularly interact with the Reporting Manager.
• Quality Control.
• Manufacturing Operations.
• Manufacturing Engineering.
• Manufacturing Science and Technology (MS&T).
• Validation.
• Site Engineering.
• Digital Plant.
  
  

Requirements

• 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, medical device analytical testing is highly desirable.
• Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
• Knowledge of electronic systems including any of the following: SAP, LIMS, Track Wise, 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.