Quality Inspection Jobs in Maine

Hands-on experience with the management of Quality System Processes such as Deviation, CAPA, and Change Controls.

Hands-on experience with the management of Quality System Processes such as Deviation, CAPA, and Change Controls required.

Provides guidance/coaching to less experienced colleagues.

Manufacturing, Laboratory, quality, technical or engineering experience within biotech of pharmaceutical industry.

Demonstrated skills in analysis and problem-solving.

5 years of diversified experience in a clinical trial, pharmaceutical or biopharmaceutical manufacturing environment.

Experience with mock inspection planning and response management

Evaluating risk management processes and documentation

Experience with global regulatory agency requirements, with focus on US FDA requirements

Providing input on standards and processes for ensuring compliance with regulatory requirements as well as corporate and departmental procedures

Bachelor’s degree with 10+ years’ experience in quality assurance

Excellent interpersonal, problem solving and negotiation skills

Experience in people leadership, managing global teams and coordinating collaboration with cross-functional teams

Strong strategic thinking, planning, execution, and communication skills

Global/international experience required, including ability to collaborate with colleagues and staff in other locations

Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development

Director, GCP Inspection Strategy -REMOTE

Lead Inspection Readiness and Strategy support forteams prior to anticipated global and regional regulatory inspections (BIMO, pre-approval, GCP inspections, etc.)

Requirements: Candidate must have at least 10 years of quality assurance experience, which includes:

Practical experience performing in-process and final inspections on machined parts, assemblies, and / or sub-assemblies.

Thorough experience with J-STD-001 soldering, IPC 600 and/or IPC 610 inspection standards.

Experience performing inspections in aerospace or military / defense manufacturing

Pay rate will be commensurate with experience.

Must have the ability to read / interpret engineering drawings and Purchase Orders (POs).

Qualification of New suppliers, management of the Approved supplier database, and creation/ review of Quality Agreements

> 5 years’ project management of multi-disciplinary teams

Utilize expertise of quality systems, data integrity, software compliance and GMP requirements to conduct internal quality audits

Monitor and manage Supplier Complaint Process

Undergraduate degree in engineering, science, or other degree with applicable experience

2-4 years of relevant experience applying regulations and communicating with regulatory agencies, Animal Health/ Pharma industry.