Manufacturing Compliance Specialist

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

Benefits offered by this job

Restaurant d'entreprise

Indemnités de stage/alternance

Job summary

Avecia Pharma in Massachusetts is seeking a Manufacturing Compliance Specialist to support quality and safety investigations and the drafting and revision of GMP documentation within the Manufacturing group.

You will work with Manufacturing managers and leads to uphold a culture of quality and safety, lead root-cause analysis, and assist with SOPs, batch records, audits, and training to ensure continual compliance across operations.

Qualifications

• 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.

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.

Skills

Technical writing

Communication

Root cause analysis

Team leadership

Lean/SS certification

Education

Bachelor's degree in a technical field

Tools

Microsoft Excel

Statistical software

Job description

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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.