Manufacturing Compliance Specialist

Nitto Avecia; Milford (MA); On-site; USD 78,000 - 94,000; Full time

Job summary

Nitto Avecia is seeking a Manufacturing Compliance Specialist to support quality and safety investigations, corrective actions, and the creation and revision of quality documentation within the Manufacturing group. The role collaborates with managers, supervisors, and leads to foster a culture of compliance and continuous improvement.

The ideal candidate has a technical BS with 3-5 years in a cGMP pharmaceutical setting, strong technical writing, and experience conducting root cause analyses.

Qualifications

• A BS in a technical discipline is required; Chemistry, Biology, or Engineering preferred.
• 3-5 years of experience in a cGMP pharmaceutical manufacturing environment with experience writing investigations and quality documents.
• Experience leading departmental and cross-functional teams through peer-to-peer influence is recommended.
• Lean/SS certification is preferred.
• Strong technical writing and communication skills are required.
• Experience leading root cause analysis is recommended.
• Proficiency with Microsoft applications and Excel graphing tools; knowledge of statistical software is preferred.

Responsibilities

• Facilitate, document, and review compliance investigations to identify root causes and ensure corrective actions are effective and compliant.
• Originating and revising manufacturing SOPs and batch records.
• Audit quality and safety compliance systems including risk assessment, 5S, training, documentation, and manufacturing operations for continual compliance.
• Support on-time performance within the department using visual management tools.
• Provide training opportunities for manufacturing staff in quality and safety compliance.
• Provide technical writing support for quality investigations and ensure reporting standards are met.

Skills

Technical writing

Root cause analysis

Cross-functional teamwork

Communication skills

Education

Bachelor's degree in Chemistry, Biology, or Engineering

Tools

Excel

Microsoft Office

Statistical software

Job description

About This Opportunity

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.

Key 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.

Required Skills/Abilities

• 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.


• Experience leading departmental and cross-functional teams through effective peer-to-peer influence is strongly recommended.


• Lean/SS certification is preferred.


• Must have strong technical writing and communication skills.


• Experience leading root cause analysis is strongly recommended.


• Must be experienced with standard Microsoft business applications and proficient with Excel graphing tools. Knowledge of statistical software tools is preferred.

The annualized salary range for this role is $77,500.00 - $94,000.00.