Materials Specialist

Tucker Parker Smith Group (TPS Group); Novato (CA); On-site; USD 76,000 - 83,000; Full time

Job summary

Tucker Parker Smith Group (TPS Group) is seeking a Material Sciences Specialist in California to support a global material specification remediation program within a leading pharmaceutical organization. You will review, update, and implement raw material specifications in line with compendial, quality, and internal requirements.

The ideal candidate has a strong GMP background, experience with raw material specifications, pharmacopeial standards, CAPA and change controls, and technical

Qualifications

• Bachelor's degree in a scientific discipline (Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering) required.
• 3–4+ years of pharma/biotech experience in material sciences, Quality, QC, or Regulatory.
• Experience with GMP/cGMP documentation and controlled documents.
• Experience with CAPAs, change controls, and deviations.

Responsibilities

• Review raw material specifications against current compendial requirements (USP, Ph. Eur./EP, JP).
• Revise specifications for excipients, chemicals, and process materials.
• Compile technical documentation and rationale for spec updates.
• Support change controls and CAPA-related activities.
• Coordinate impact assessments with cross-functional SMEs.
• Maintain specification inventories and implementation trackers.
• Ensure documentation meets GMP and specification templates.
• Assist regulatory inspections and CAPA effectiveness reviews.

Skills

Technical writing

Regulatory compliance knowledge

Cross-functional collaboration

GMP familiarity

Education

Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline

Tools

Veeva

eQMS

Document management systems

Job description

Pay Rate: $55–$60/hour

Contract: W-2 Contract through March 2027

Position Summary

We are seeking a Material Sciences Specialist to support a global material specification remediation program within a leading pharmaceutical organization. This position will support regulatory commitments and CAPA activities by reviewing, updating, and implementing raw material specifications in accordance with current compendial, quality, and internal requirements.

The ideal candidate will have a strong background in GMP environments, raw material specifications, pharmacopeial standards, technical documentation, change controls, and CAPAs.

Key Responsibilities

• Review existing raw material specifications against current compendial requirements.
• Compare USP, Ph. Eur./EP, JP, Client, and supplier specifications as applicable.
• Revise specifications for excipients, chemicals, and process materials.
• Compile technical documentation and supporting rationale for specification updates.
• Support initiation and execution of change controls and CAPA-related activities.
• Coordinate impact assessments and follow up with cross-functional SMEs on outstanding actions.
• Maintain specification inventories, implementation trackers, and status reports.
• Verify technical data consistency across specifications and supporting documentation.
• Ensure documentation meets approved GMP and specification templates.
• Support inspection readiness and preparation of documentation for regulatory inspections and CAPA effectiveness reviews.
• Collaborate with Material Sciences, Quality, QC, Regulatory Affairs, Manufacturing, Supply Chain, and Procurement teams.

Required Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline.
• 3–4+ years of experience within pharmaceutical/biotech manufacturing, Quality, QC, Material Sciences, Technical Services, or Regulatory Compliance.
• Experience working with GMP/cGMP documentation.
• Strong technical writing and controlled-document revision skills.
• Experience with CAPAs, change controls, and/or deviation systems.
• Working knowledge of pharmacopeial standards, including USP, EP/Ph. Eur., and JP.
• Ability to independently manage multiple priorities and work cross-functionally.

Preferred Qualifications

• Experience developing or maintaining raw material, excipient, or chemical specifications.
• Knowledge of supplier quality systems and raw material control strategies.
• Experience supporting regulatory remediation programs or inspection readiness.
• Experience with Veeva, electronic quality systems (eQMS), or document management systems.
• Previous experience within a regulated pharmaceutical or biotechnology environment.