Material Specifications Specialist – Regulatory & CAPA Support

TALENT Software Services; Novato (CA); On-site; USD 90,000 - 135,000; Full time

Job summary

BioMarin is seeking a temporary contractor to support a global material specification remediation program, collaborating with Global Quality, Regulatory Compliance, and Site Quality to review, revise, implement, and maintain raw material specifications in line with compendial and internal requirements.

The role involves change control execution, CAPA tracking, data management, and cross-functional coordination to ensure regulatory alignment and inspection readiness.

Qualifications

• BS degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related field.
• 3-4 years of pharmaceutical manufacturing, quality, technical services, material sciences, or regulatory compliance.
• Experience working with GMP documentation.
• Strong technical writing and document revision skills.
• Familiarity with change controls, CAPAs, and deviation systems.
• Knowledge of pharmacopeial standards (USP, EP, JP).

Responsibilities

• Review existing raw material specifications against current compendial requirements.
• Compare USP, Ph. Eur., JP, Client, and supplier specifications where applicable.
• Support revision of excipient, chemical, and process material specifications.
• Compile technical justification packages and supporting rationale for specification updates, where appropriate.
• Support initiation and execution of change controls related to specification updates.
• Coordinate impact assessments from affected functional groups.
• Track implementation progress and CAPA milestones.
• Assist with closure documentation and inspection readiness activities.
• Maintain specification inventories and implementation trackers.
• Generate summary reports and status dashboards.
• Verify technical data consistency across specifications and supporting documents.
• Ensure document formatting aligns with approved specification templates.
• Work with Material Sciences, Quality Systems, Quality Control, Regulatory Affairs, Supply Chain, Manufacturing, and Procurement.
• Follow up with SMEs regarding impact assessments and outstanding actions.
• Support meeting preparation and action item tracking.
• Assemble supporting documentation for regulatory inspections and CAPA effectiveness reviews.
• Support ongoing alignment of specifications with compendial and regulatory expectations.

Skills

Technical writing

Documentation control

GMP documentation

Education

BS degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline

Tools

Veeva

Electronic quality systems

Job description

BioMarin is seeking a temporary contractor to support a global material specification remediation program, collaborating with Global Quality, Regulatory Compliance, and Site Quality to review, revise, implement, and maintain raw material specifications in line with compendial and internal requirements.

The role involves change control execution, CAPA tracking, data management, and cross-functional coordination to ensure regulatory alignment and inspection readiness.