Integrated Resources
Job Title:
QA Lead - Technical Operations Work Location : 100% Onsite, Devens, MA 01434 Duration:
6 months+
Pay range: $65/hr. on W2
Work Schedule: Monday - Friday, First Shift (8:30 AM - 5:00 PM)
Top Skills / Must Haves:
Experience with Quality Control Equipment (preferred) Technical Writing expertise Investigations / Deviation handling experience (preferred)
Job Description / Responsibilities:
Provide Quality Assurance (QA) support at the Devens site and to Reporting Manager through review and approval of Investigations and Corrective Actions Make decisions on non-conformance using a deep understanding of Quality Systems and Regulatory expectations Review and approve documents related to Quality, Quality Control, Validation, and Automation Review and approve Standard Operating Procedures (SOPs) Review and approve Validation documentation including risk assessments, protocols, test scripts, and summary reports Review and approve change proposals and associated deliverables ensuring compliance with regulatory and internal guidelines Coach departments on Investigations, CAPAs, risk assessments, and Validation subject matter Self-manage and prioritize multiple deliverables independently Interpret complex data and make sound decisions autonomously
Key Interactions:
Reporting Manager (regular) Occasionally interacts with:
Quality Control Manufacturing Operations Manufacturing Engineering Manufacturing Science and Technology (MS&T) Validation Site Engineering Digital Plant
Education, Experience, and Qualifications:
Bachelor's degree in Biological Science, Engineering, Biochemistry, or related field preferred 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 some project management Knowledge of biotech, bulk drug substance or finished product manufacturing, and medical device analytical testing preferred Extensive knowledge of US and EU cGMP regulations, guidance, and GAMP 5 Familiarity with electronic systems such as SAP, LIMS, TrackWise, Veeva Vault, and electronic/paper batch records desirable Excellent technical writing and verbal communication skills required Strong problem-solving background Understanding of data integrity principles Proven attention to detail Comfortable working in FDA regulated environments
QA Lead - Technical Operations Work Location : 100% Onsite, Devens, MA 01434 Duration:
6 months+
Pay range: $65/hr. on W2
Work Schedule: Monday - Friday, First Shift (8:30 AM - 5:00 PM)
Top Skills / Must Haves:
Experience with Quality Control Equipment (preferred) Technical Writing expertise Investigations / Deviation handling experience (preferred)
Job Description / Responsibilities:
Provide Quality Assurance (QA) support at the Devens site and to Reporting Manager through review and approval of Investigations and Corrective Actions Make decisions on non-conformance using a deep understanding of Quality Systems and Regulatory expectations Review and approve documents related to Quality, Quality Control, Validation, and Automation Review and approve Standard Operating Procedures (SOPs) Review and approve Validation documentation including risk assessments, protocols, test scripts, and summary reports Review and approve change proposals and associated deliverables ensuring compliance with regulatory and internal guidelines Coach departments on Investigations, CAPAs, risk assessments, and Validation subject matter Self-manage and prioritize multiple deliverables independently Interpret complex data and make sound decisions autonomously
Key Interactions:
Reporting Manager (regular) Occasionally interacts with:
Quality Control Manufacturing Operations Manufacturing Engineering Manufacturing Science and Technology (MS&T) Validation Site Engineering Digital Plant
Education, Experience, and Qualifications:
Bachelor's degree in Biological Science, Engineering, Biochemistry, or related field preferred 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 some project management Knowledge of biotech, bulk drug substance or finished product manufacturing, and medical device analytical testing preferred Extensive knowledge of US and EU cGMP regulations, guidance, and GAMP 5 Familiarity with electronic systems such as SAP, LIMS, TrackWise, Veeva Vault, and electronic/paper batch records desirable Excellent technical writing and verbal communication skills required Strong problem-solving background Understanding of data integrity principles Proven attention to detail Comfortable working in FDA regulated environments