Mindlance
Job Description: QA Lead Technical Operations, Projects
Location:
Onsite, Devens Work Schedule:
Mon - Fri, First shift (8:30AM - 5PM) Responsibilities: Provide Quality Assurance (QA) support to Devens Site and reporting Manager through review and approval of investigations and corrective actions. Make decisions regarding non-conformance based on a thorough understanding of Quality Systems and Regulatory expectations. Review and approve quality, quality control, validation, and automation related documents. Review and approve Standard Operating Procedures (SOPs). Review and approve validation documents such as risk assessments, protocols, test scripts, and summary reports. Review and approve change proposals and related deliverables, ensuring compliance with regulatory and internal guidelines. Coach departments on investigations, CAPAs, risk assessments, and validation processes. Manage and prioritize multiple deliverables in a remote work environment. Interpret complex data and make sound independent decisions.
Interaction:
Regular interaction with Reporting Manager; occasional interaction with departments including Quality Control, Manufacturing Operations, Engineering, MS&T, Validation, Site Engineering, and Digital Plant. Qualifications:
B.S. in Biological Science, Engineering, Biochemistry, or related discipline, or equivalent. At least 8 years of relevant experience in GMP, GCP, or GXP environments focused on product quality; active membership in ASQ or ISPE preferred. Experience with QC equipment qualification and project management. Knowledge of biotech, drug substance, finished product manufacturing, or medical device testing is highly desirable. Extensive knowledge of US and EU cGMP regulations, GAMP 5, and electronic systems like SAP, LIMS, TrackWise, Veeva Vault. Excellent technical writing and communication skills. Strong problem-solving skills and knowledge of data integrity principles. Attention to detail and experience working in FDA-regulated environments.
Additional Requirements:
Must be able to work onsite Monday through Friday, first shift. EEO Statement:
Mindlance is an Equal Opportunity Employer and does not discriminate based on minority, gender, disability, religion, LGBTQI, age, or veteran status. #J-18808-Ljbffr
Location:
Onsite, Devens Work Schedule:
Mon - Fri, First shift (8:30AM - 5PM) Responsibilities: Provide Quality Assurance (QA) support to Devens Site and reporting Manager through review and approval of investigations and corrective actions. Make decisions regarding non-conformance based on a thorough understanding of Quality Systems and Regulatory expectations. Review and approve quality, quality control, validation, and automation related documents. Review and approve Standard Operating Procedures (SOPs). Review and approve validation documents such as risk assessments, protocols, test scripts, and summary reports. Review and approve change proposals and related deliverables, ensuring compliance with regulatory and internal guidelines. Coach departments on investigations, CAPAs, risk assessments, and validation processes. Manage and prioritize multiple deliverables in a remote work environment. Interpret complex data and make sound independent decisions.
Interaction:
Regular interaction with Reporting Manager; occasional interaction with departments including Quality Control, Manufacturing Operations, Engineering, MS&T, Validation, Site Engineering, and Digital Plant. Qualifications:
B.S. in Biological Science, Engineering, Biochemistry, or related discipline, or equivalent. At least 8 years of relevant experience in GMP, GCP, or GXP environments focused on product quality; active membership in ASQ or ISPE preferred. Experience with QC equipment qualification and project management. Knowledge of biotech, drug substance, finished product manufacturing, or medical device testing is highly desirable. Extensive knowledge of US and EU cGMP regulations, GAMP 5, and electronic systems like SAP, LIMS, TrackWise, Veeva Vault. Excellent technical writing and communication skills. Strong problem-solving skills and knowledge of data integrity principles. Attention to detail and experience working in FDA-regulated environments.
Additional Requirements:
Must be able to work onsite Monday through Friday, first shift. EEO Statement:
Mindlance is an Equal Opportunity Employer and does not discriminate based on minority, gender, disability, religion, LGBTQI, age, or veteran status. #J-18808-Ljbffr