Manufacturing Compliance Specialist

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

Job summary

Avecia Pharma is seeking a Manufacturing Compliance Specialist to support quality and safety investigations, ensure corrective actions are effective, and help maintain compliant documentation across the manufacturing group.

The role partners with managers and staff to drive root cause analysis, revise SOPs and batch records, participate in audits, and promote a culture of quality and safety through strong technical writing and cross-functional collaboration.

Qualifications

• BS in chemistry, biology or engineering required.
• 3–5 years in a cGMP pharmaceutical manufacturing environment writing investigations and quality documents.
• Strong technical writing and communication skills.

Responsibilities

• Facilitate, document, and review investigations to identify root causes and ensure corrective actions.
• Support originating and revising SOPs and batch records.
• Audit quality and safety systems to ensure continual compliance.
• Assist with on-time performance using visual management tools.
• Provide training on quality and safety compliance for manufacturing staff.
• Provide technical writing support for quality investigations.

Skills

Technical writing

Root cause analysis

Lean/SS certification

Excel

Cross-functional teamwork

Communication skills

cGMP experience

Statistical software

Education

BS in Chemistry / Biology / Engineering

Tools

Microsoft Excel

MS Office

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.