Materials Specifications Specialist - Contract (GMP)

BioMarin Pharmaceutical Inc.; Novato (CA); On-site; USD 55,000 - 96,000; Part time

Job summary

BioMarin Pharmaceutical Inc. is seeking a temporary contractor to support execution of a global material specification remediation program associated with regulatory commitments and CAPA activities.

The contractor will work closely with Material Sciences, Global Quality, Regulatory Compliance, and Site Quality teams to review, revise, implement, and maintain raw material specifications in accordance with compendial and internal requirements.

Qualifications

• BS degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline.
• 3–4 years of experience in 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, ACS, 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

GMP documentation

Technical writing

Change controls

CAPA processes

Pharmacopeial standards USP/EP/JP

Education

BS degree in Chemistry/Pharmaceutical Sciences

Tools

Veeva

Electronic quality systems

Job description

BioMarin Pharmaceutical Inc. is seeking a temporary contractor to support execution of a global material specification remediation program associated with regulatory commitments and CAPA activities.

The contractor will work closely with Material Sciences, Global Quality, Regulatory Compliance, and Site Quality teams to review, revise, implement, and maintain raw material specifications in accordance with compendial and internal requirements.