| Quality Engineer :: Boston Andover, MA area at Boston, Massachusetts, USA |
| Email: [email protected] |
|
http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=3319352&uid=3aef7b407915486f906ab95527c51957 From: praveen nagar, vyzeinc.com [email protected] Reply to: [email protected] Job Description - Job Description - Provide LinkedIn (old) with good connection and profile picture . will need 2 manager references that have LinkedIn profiles they can contact, or a letter of recommendation they can attach with the resume. Pharmaceutical Company Quality Engineer (& Supplier Quality) 6 month contract Boston/Andover, MA area Interview: video, asap Skills: Quality Engineering Experience having worked on remediation project (pharmaceutical) support fixing compliance gapsoften after inspections, audits, or major deviations Remediation is high-risk and highly scrutinized (especially by regulators like the U.S. Food and Drug Administration), the experience requirements tend to be higher than for routine QA roles. Expectations: Core Industry Experience 512+ years in pharmaceutical or biotech manufacturing. That experience should include: Quality Assurance (QA) or Quality Control (QC) Manufacturing operations or technical support Direct exposure to regulated environments (cGMP) Strong Knowledge of Regulations Strongly desired - deep understanding of: cGMP (Current Good Manufacturing Practice) regulations preferred experience with Guidelines from International Council for Harmonization (ICH Q7, Q9, Q10 especially) Data integrity principles (ALCOA+) Regulatory expectations from agencies like FDA, EMA, etc. Direct Remediation Experience (Highly Valued) Preferred - Worked on 483 observations or warning letter responses Participated in or led remediation programs after audits/inspections Experience with CAPA (Corrective and Preventive Actions) systems Root cause investigation using tools like or similar to: Fishbone diagrams 5 Whys Fault tree analysis Audit & Inspection Readiness Experience supporting or leading regulatory inspections Ability to interact with inspectors confidently Conducting internal audits and gap assessments Technical & Documentation Skills Writing and revising SOPs, deviations, and investigation reports Reviewing batch records and validation documentation Knowledge of validation (process, cleaning, computer systems Preferred to have some knowledge/experience w/Project & Stakeholder Management Project management experience (timelines, deliverables, tracking) Ability to coordinate with manufacturing, engineering, QC, and leadership Experience working under pressure with strict deadlines Soft Skills Critical thinking and problem-solving Strong written communication (regulators read everything) Attention to detail Ability to challenge processes without disrupting operations Nice-to-Have Backgrounds Previous work at companies under consent decree or major remediation Consulting experience in pharma quality Six Sigma or Lean certification , , Yellow, Black belt Experience with electronic quality systems (TrackWise, Veeva Hire our IT Recruiter at just $499/month. Keywords: quality analyst information technology card Massachusetts Quality Engineer :: Boston Andover, MA area [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=3319352&uid=3aef7b407915486f906ab95527c51957 |
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| 06:34 PM 23-Apr-26 |