Manufacturing Compliance Specialist

Nitto Denko Corp. • Milford, MA

52d • $77,500 - $94,000

About The Position

The Manufacturing Compliance Specialist position is responsible for supporting all compliance (Quality and Safety) investigations and corrective actions, as well as the origination and revision of quality documentation in support of the Manufacturing group. This person will work with Manufacturing managers, supervisors, and leads to assure the growth and maintenance of a quality and safety compliance culture.

Requirements

• A BS in a technical discipline is required, Chemistry, Biology, Engineering preferred.
• 3-5 years of experience in a cGMP pharmaceutical manufacturing environment with demonstrate experience writing investigations and other quality documents.
• Must have strong technical writing and communication skills.
• Must be experienced with standard Microsoft business applications and proficient with Excel graphing tools.

Nice To Haves

• Experience leading departmental and cross-functional teams through effective peer-to-peer influence is strongly recommended.
• Lean/SS certification is preferred.
• Experience leading root cause analysis is strongly recommended.
• Knowledge of statistical software tools is preferred.

Responsibilities

• Facilitate, document, and review compliance related investigations to ensure root causes are identified, corrective actions implemented, and the effectiveness of these corrective actions fulfill regulatory and business requirements.
• Support project team with originating and revising manufacturing related SOPs and batch records.
• Supports audits of all quality and safety compliance systems including safety analysis/risk assessment, 5S, training, documentation, and general manufacturing operations to assure continual compliance.
• Would support on time performance within the department using visual management tools.
• Support training opportunities for manufacturing staff in the areas of quality and safety compliance.
• Provide technical writing support for quality investigations and assure standards for investigational reporting are met.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level